Department of Health and Human Services
OFFICE OF 
 
INSPECTOR GENERAL 
 
 
 
 
 
 
 
 
ADVER  SE EVENT REPORTING 
 
M D  
FOR  EDICAL  EVICES
 
   
 
 
 
 
 
 
Daniel R. Levinson  
Inspector General 
 
October 2009 
OEI-01-08-00110   
 
Office of Inspector General 
http://oig.hhs.gov 
 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as 
amended, is to protect the integrity of the Department of Health and Human Services 
(HHS) programs, as well as the health and welfare of beneficiaries served by those 
programs.  This statutory mission is carried out through a nationwide network of audits, 
investigations, and inspections conducted by the following operating components: 
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examine the performance of HHS programs and/or its grantees and contractors in carrying 
out their respective responsibilities and are intended to provide independent assessments of 
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mismanagement and promote economy and efficiency throughout HHS. 
Office of Evaluation and Inspections 
The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide 
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issues.  These evaluations focus on preventing fraud, waste, or abuse and promoting 
economy, efficiency, and effectiveness of departmental programs.  To promote impact, OEI 
reports also present practical recommendations for improving program operations.  
Office of Investigations 
The Office of Investigations (OI) conducts criminal, civil, and administrative investigations 
of fraud and misconduct related to HHS programs, operations, and beneficiaries.  With 
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by actively coordinating with the Department of Justice and other Federal, State, and local 
law enforcement authorities.  The investigative efforts of OI often lead to criminal 
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Office of Counsel to the Inspector General 
The Office of Counsel to the Inspector General (OCIG) provides general legal services to 
OIG, rendering advice and opinions on HHS programs and operations and providing all 
legal support for OIGs internal operations.  OCIG represents OIG in all civil and 
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also negotiates and monitors corporate integrity agreements.  OCIG renders advisory 
opinions, issues compliance program guidance, publishes fraud alerts, and provides other 
guidance to the health care industry concerning the anti-kickback statute and other OIG 
enforcement authorities.   
   
I N T R O D U C T I O N  
 E X E C U T I V E   S U M M A R Y  
OBJECTIVES
 
1.  To determine the extent of adverse event reporting from 2003 to 
2007 by manufacturers and facilities that use medical devices. 
2.  To determine the extent to which manufacturers and facilities that 
use medical devices comply with adverse event reporting 
requirements for medical devices. 
3.  To assess how the Food and Drug Administration (FDA) uses 
medical device adverse event data to identify and address safety 
concerns. 
BACKGROUND 
Adverse event reporting enables FDA to take corrective action on 
problem devices and to prevent injury and death by alerting the public 
when potentially hazardous devices are discovered.  Within FDA, the 
Center for Devices and Radiological Health (CDRH) is responsible for 
regulating medical devices. 
Regulations require device manufacturers to report to FDA (1) within       
30 calendar days of acquiring information that reasonably suggests one 
of their devices may have caused or contributed to a death, serious 
injury, or malfunction and (2) within 5 working days if an event 
requires action other than routine maintenance or service to prevent a 
public health issue.  Regulations also require user facilities, such as 
hospitals and nursing homes, to report deaths to both the manufacturer, 
if known, and FDA within 10 working days.  User facilities must report 
serious injuries to the manufacturers (or FDA if the manufacturer is 
unknown) within 10 working days.  User facilities must also submit 
annual reports to FDA of all adverse event reports sent to 
manufacturers or FDA in the past year. 
We used six data sources for this study:  the Manufacturer and User 
Facility Device Experience (MAUDE) database, the alternative 
summary reports database, annual user facility reports, CDRH files on 
regulatory actions, structured interviews with CDRH analysts, and 
interviews with CDRH senior officials. 
 
 
  OEI-01-08-00110  ADVERSE EVENT REPORTING FOR MEDICAL DEVICES  i   
   
E X E C U T I V E   S U M M A R Y  
FINDINGS 
Overall, FDA received twice as many adverse event reports for 
medical devices in 2007 than in 2003; however, some types of 
reports decreased.  Manufacturers, user facilities, and other reporters 
submitted 72,866 medical device adverse event reports in 2003, which 
doubled to 150,210 reports in 2007.  Manufacturers submitted the vast 
majority of these reports.  Thirty-day reports of death, serious injury, 
and malfunction accounted for almost all manufacturer reports and 
drove the overall increase in adverse event reports.   
Five-day reports made up less than 1 percent of manufacturer reports.  
Although the total number of manufacturer reports increased 
substantially, 5-day reports fell from 432 to 54 reports per year over the 
5-year period.   
Manufacturers submitted most adverse event reports on time, but 
many 5-day manufacturer and user facility reports were late.  In 
2007, manufacturers submitted 89 percent of all 30-day reports on time.  
This percentage has remained relatively unchanged since 2003.  
Although manufacturers submitted only 54 5-day reports in 2007,        
31 percent of them were late.  This was a decrease from a high of         
64 percent in 2003 but an increase from 7 percent in 2005.   
In 2007, user facilities submitted 39 percent of both death and injury 
adverse event reports late to FDA.  From 2003, the percentage late 
ranged from 30 percent to 45 percent.  Likewise, user facilities 
submitted at least 42 percent of adverse event reports late to 
manufacturers in each year from 2003 to 2007.   
CDRH does not use adverse event reports in a systematic manner to 
detect and address safety concerns about medical devices.  
Analysts have documented little of their reviews, which can make it 
difficult to trace the response to an individual event.  Outcomes of 
adverse events can result in a variety of postmarket surveillance 
activities; however, at this time CDRH cannot link these activities to 
particular adverse events.  CDRH also lacks an established system to 
document when adverse event reports result in onsite inspections.  
CDRHs Office of Compliance does not document which reports resulted 
in inspections when analysts refer the reports.  CDRH also does not 
document onsite inspections in its adverse event database (MAUDE).   
CDRH does not consistently read adverse event reports for the first time 
in a timely manner.  Analysts read fewer than one-third of adverse 
  OEI-01-08-00110  ADVERSE EVENT REPORTING FOR MEDICAL DEVICES  ii   
   
E X E C U T I V E   S U M M A R Y  
event reports for the first time within 30 days and less than half within 
60 days in every year from 2003 to 2007.  CDRHs procedures require          
that high-priority adverse event reports be in MAUDE and ready for 
analysts to review within 96 hours of receipt; however, we were unable 
to verify CDRHs compliance with these procedures through its 
documents. 
CDRH rarely acts when manufacturers and user facilities submit 
reports late.  Analysts told us they generally forward concerns about 
timeliness only when they notice pervasive problems, and they usually 
handle concerns informally by calling the manufacturers.   
The inability to obtain complete and usable information in adverse 
event reports hinders analysts review of reports.  Analysts also pointed 
to MAUDE as an impediment because they cannot easily conduct trend 
analysis and MAUDE does not connect with other CDRH databases. 
CDRH makes limited use of annual reports.  We identified at least      
526 user facilities that should have submitted annual reports for 2006, 
but CDRH could provide only 220 annual reports for that year.  We 
could not determine whether facilities did not submit reports or whether 
CDRH was unable to supply copies.   
RECOMMENDATIONS 
To improve how FDA uses adverse event reports to identify and address 
safety concerns, FDA should: 
Develop a protocol for reviewing adverse event reports that 
specifically addresses the following needs:   
Document followup on adverse events.  CDRH should develop systems 
that reference the actions it takes on particular adverse event reports.  
In addition, CDRH should consider developing a tracking system to 
follow the outcome of referrals sent to the Office of Compliance.  
Ensure and document that CDRH is meeting its guidelines for reviewing all 
5-day and Code Blue adverse event reports.  CDRH established 5-day 
and Code Blue reports (reports of pediatric deaths, multiple deaths, 
exsanguinations, explosions, fires, burns, electrocutions, and 
anaphylaxis) as the highest priority reports.  Following its own 
procedures, which require that contractors enter all high-priority 
reports in MAUDE within 24 hours and analysts first read them within           
96 hours, would ensure that CDRH knew whether manufacturers took 
the appropriate steps. 
  OEI-01-08-00110  ADVERSE EVENT REPORTING FOR MEDICAL DEVICES  iii   
   
E X E C U T I V E   S U M M A R Y  
Follow up with manufacturers that routinely submit reports late or with 
incomplete information.  CDRH should identify and target manufacturers 
and user facilities with a history of noncompliance with adverse event 
submission requirements.   
Enhance outreach strategies to reduce underreporting by user facilities. 
CDRH should consider implementing strategies such as the type of 
additional training and outreach that the MedSun program has used to 
work effectively with its participants to increase reporting.  
Seek legislative authority to eliminate the requirement for user 
facilities to submit annual reports.  Eliminating this requirement       
(21 U.S.C.  360i(b)(c)) would decrease the regulatory burden on user 
facilities, as well as CDRH.  Other than a count of total adverse event 
reports, all of the information in the annual reports is redundant to the 
originally submitted reports.    
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 
RESPONSE 
FDA agreed with both of our recommendations.  In response to our first 
recommendation, FDA said that CDRH will develop a clear review 
protocol that addresses the needs our report identified.  To achieve this, 
FDA stated that its new FDA Adverse Event database will allow for 
more extensive documentation of followup on adverse events and permit 
FDA to more readily identify late and incomplete reports.  FDA also 
stated that CDRH has developed a tracking system that facilitates 
referrals to the Office of Compliance and follows up on them.  Finally, 
FDA will identify steps it will take to stimulate user facility reporting.  
Because FDA stated that a change in statutory authority would be 
needed to eliminate the requirement to submit annual reports, we 
revised our second recommendation accordingly. 
  OEI-01-08-00110  ADVERSE EVENT REPORTING FOR MEDICAL DEVICES  iv   
 
 T A B L E   O F   C O N T E N T S  
 
EXECUTIVE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
 
I N T RO DUC T IO N . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 
 
 
F I N D IN G S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9  
Overall, FDA received twice as many adverse event reports 
for medical devices in 2007 than in 2003; however, some 
types of reports decreased . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9  
Manufacturers submitted most adverse event reports on 
time, but many 5-day manufacturer and user facility 
reports were late. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 
CDRH does not use adverse event reports in a systematic 
manner to detect and address safety concerns about 
medical devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 
 
 
 
R E C O MMEN D A T ION S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 
Agency Comments and Office of Inspector General 
Response. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 
 
 
APPENDIXES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 
  A:  Detailed Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 
  B:  Trends in Adverse Event Reports:  20032007 . . . . . . . . . . . . 23 
  C:  Adverse Event Reports Missing Critical Information . . . . . . . 24 
  D:  Timeliness of FDA Review of Adverse Event Reports  . . . . . . 25 
  E:  Agency Comments  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 
 
A C K NO WL E D G M E N T S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29   
   
 I N T R O D U C T I O N  
OBJECTIVES 
1.  To determine the extent of adverse event reporting from 2003 to 
2007 by manufacturers and facilities that use medical devices. 
2.  To determine the extent to which manufacturers and facilities that 
use medical devices comply with adverse event reporting 
requirements for medical devices. 
3.  To assess how the Food and Drug Administration (FDA) uses 
medical device adverse event data to identify and address safety 
concerns. 
BACKGROUND 
FDA is responsible for ensuring the safety and effectiveness of medical 
devices in this country.  These devices range from bandages and tongue 
depressors to pacemakers and implantable infusion pumps.  FDAs 
Center for Devices and Radiological Health (CDRH) has approved more 
than 20,000 firms to produce nearly 100,000 medical devices.1 2  Within 
FDA, CDRH is responsible for regulating medical devices as well as 
regulating unnecessary radiation exposure from medical, occupational, 
and consumer products.3   
Adverse event reporting represents a critical component of FDAs 
information-gathering process after it has approved or cleared a medical 
device for marketing.  Adverse event reporting enables FDA to take 
corrective action on problem devices and to prevent injury and death by 
alerting the public when potentially hazardous devices are discovered.  
Analyzing adverse event reporting also enables FDA to detect 
unanticipated events and user errors, monitor and classify recalls, 
update medical device labels, and develop educational outreach.  
Adverse event reports supply FDA with the most comprehensive source 
 
1 FDA, CDRH. Better Health Care With Quality Medical Devices:  FDA on the Cutting 
Edge of Device Technology, February 2002.  Available online at 
http://download.journals.elsevierhealth.com/pdfs/journals/1075-
4210/PIIS107542100200007X.pdf.  Last accessed on June 23, 2009. 
2 FDA, CDRH. CDRH FY 2006 Annual Report, 2006.  Available online at 
http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm129258.
pdf.  Last accessed on June 23, 2009. 
3 FDA, CDRH. About the Center for Devices and Radiological Health, June 4, 2009.  
Available online at http://www.fda.gov/AboutFDA/CentersOffices/CDRH/default.htm.  Last 
accessed on June 11, 2009. 
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I N T R O D U C T I O N  
of information about the safety and effectiveness of the device as it is 
used in everyday circumstances.  Using adverse event report data, FDA 
can detect problems previously unknown to the manufacturer as well as 
problems with similar devices or device categories. 
Adverse Event Reporting for Medical Devices  
FDA, through its MedWatch program, collects information about 
injuries and adverse events that occur when using medical devices.  
MedWatch is FDAs program for reporting serious reactions; product 
quality problems; therapeutic inequivalence or failure; and product use 
errors with human medical products, such as drugs and medical 
devices.4  Mandatory adverse event reporting began in 1984 when FDA 
set forth regulations requiring manufacturers and importers to notify 
CDRH when they become aware of a death or serious injury that may be 
associated with one of their devices or a device malfunction that would 
likely cause or contribute to a death or serious injury if that malfunction 
were to recur.5  The Safe Medical Devices Act of 1990 extended these 
reporting requirements to facilities that use medical devices 
(hereinafter referred to as user facilities), which include hospitals, 
ambulatory surgical facilities, nursing homes, and outpatient treatment 
facilities that are not physicians offices.6  The final regulations 
governing these reporting requirements took effect in 1996.7 
The Medical Device Amendments of 1992 mandated changes to the 
adverse event regulations for manufacturers and user facilities by 
requiring a single reporting standard and defining the types of injuries 
that must be reported.8 9  The regulations mandate that manufacturers 
and user facilities provide information about the patient, adverse event, 
and suspect device.10  Manufacturers must also provide the device 
 
4 FDA. MedWatchReporting by Consumers, June 8, 2009.  Available online at 
https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.   Last accessed on 
June 11, 2009. 
5 49 Fed. Reg. 36326, 36348 (Sep. 14, 1984). 
6 Safe Medical Devices Act of 1990.  P.L. No. 101-629  2, Federal Food, Drug, and 
Cosmetic Act,  519(b), 42 U.S.C.  360i(b). 
7 60 Fed. Reg. 63578 (Dec. 11, 1995); 61 Fed. Reg. 16043 (Apr. 11, 1996). 
8 Medical Device Amendments of 1992, P.L. No. 102-300  5, Federal Food, Drug, and 
Cosmetic Act,  519(a), 42 U.S.C.  360i(a). 
9 The regulations define serious injury as any illness or injury that is life threatening, 
results in permanent impairment of a body function or permanent damage to a body 
structure, or requires medical or surgical intervention to prevent such permanent effects.  
21 CFR  803.3. 
10 21 CFR  803.23, 803.52. 
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I N T R O D U C T I O N  
specifications and details about any evaluation of the device.11  User 
facilities must submit information about the specific event or problem, 
including how the device was involved and where the event or problem 
occurred.12  
Federal regulations require manufacturers to report to FDA within     
30 calendar days of acquiring information that reasonably suggests one 
of their devices may have malfunctioned or caused or contributed to a 
death or serious injury.13  Manufacturers must report within 5 working 
days if an event requires action other than routine maintenance or 
service to prevent a public health issue or if FDA has made a request for 
5-day reports.14  If a manufacturer lacks the required information at the 
time of the report or obtains additional information after submitting the 
initial report, it must provide supplemental adverse event reports to 
FDA.15    
Regulations also require user facilities to report device-related deaths to 
both the manufacturer, if known, and FDA within 10 working days.16  
User facilities must also report device-related serious injuries to the 
manufacturers (or FDA if the manufacturer is unknown) within           
10 working days.17  In addition, user facilities must submit annual 
reports to FDA that include either summaries or copies of all adverse 
event reports sent to manufacturers or FDA in the past year.18  Table 1 
summarizes the reporting requirements for manufacturers and user 
facilities. 
 
 
 
 
 
 
 
11 21 CFR  803.52. 
12 21 CFR  803.11, 803.32; MedWatch Form FDA 3500A.  Available online at 
http://www.fda.gov/downloads/Safety/MedWatch/HowToReport/DownloadForms/ucm08272.
pdf.  Last accessed on March 12, 2009. 
13 21 CFR  803.3 and 803.10(c)(1). 
14 21 CFR  803.3 and 803.10(c)(2). 
15 21 CFR  803.10(c)(3). 
16 21 CFR  803.10(a)(1)(i). 
17 21 CFR  803.10(a)(1)(ii). 
18 21 CFR  803.10(a)(2) and 803.33. 
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I N T R O D U C T I O N  
Table 1:  Adverse Event Reporting Requirements 
 
 
Who Is Reporting What To Report To Whom To Report When To Report
 
  Events that require remedial 
action to prevent an 
  unreasonable risk of  Within 5 working days 
substantial harm to the public FDA of becoming aware of 
 Medical Device  health and other types of  the event
Manufacturer events designated in writing 
  by FDA
  Deaths, serious injuries, and  Within 30 calendar 
FDA days of becoming 
malfunctions
  aware of the event
Manufacturer (if known)  Within 10 working 
Deaths
  and FDA days of the event
Manufacturer (if known)  Within 10 working 
Serious injuries
  or FDA days of the event
User Facility
Annual reports of all adverse 
  Annually (by January 
events the facility reported  FDA
1st)
during the past year
 
 Source:  21 CFR  803. 
 
Consumers and health care professionals may voluntarily submit 
adverse event reports.19  In fiscal year (FY) 2006, FDA received              
114,291 mandatory reports and 5,265 voluntary reports.20    
Alternative Summary Reports 
On October 1, 1999, CDRH began accepting requests to participate in 
the alternative summary report (ASR) program, which allows 
manufacturers to submit abbreviated and aggregated adverse event 
reports.21  Manufacturers must apply for permission from FDA to 
submit quarterly ASRs for individual medical devices.22  For all other 
devices, manufacturers continue to submit full adverse event reports.  
Manufacturers must submit ASRs within 1 month following the 
 
19 FDA.  How to Report a Medical Device Problem.  Available online at 
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/FormsandInstructions/default.h
tm.  Last accessed on June 16, 2009. 
20 FDA, CDRH.  FY 2006 Annual Report, September 2007.  Available online at 
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm129324.htm.  Last 
accessed on June 16, 2009. 
21 FDA, CDRH.  Medical Device ReportingAlternative Summary Reporting Program, 
October 2000.  Available online at 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc
m072029.htm.  Last accessed on June 16, 2009. 
22 Ibid. 
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I N T R O D U C T I O N  
reporting quarter.  FDA stores ASRs in a different database than other 
manufacturer reports.   
Rather than individually reviewing ASRs, CDRH conducts trend 
analyses on them, such as calculating occurrence rate changes for 
specific events.  CDRH may request a manufacturer to submit a full 
report if it needs additional information about a specific event.  In       
FY 2006, CDRH received information about 104,641 adverse events 
submitted through ASRs.23   
MedSun Program 
In 2002, CDRH launched the Medical Product Safety Network 
(MedSun) pilot project to increase user facility reporting rates and 
improve the quality of reports.  About 350 user facilities, primarily 
hospitals, participate voluntarily.  This represents a small fraction of 
the thousands of hospitals, nursing homes, ambulatory surgical centers, 
and outpatient treatment facilities that use devices.  MedSun 
participants submit additional information that could help improve the 
safe and effective use of medical devices.24  
MedSun analysts work closely with participating user facilities to assist 
them in determining the appropriate response to adverse events.  User 
facilities receive additional training on reporting events and feedback 
regarding the reports that they submitted.  In addition to mandating 
reporting of deaths and serious injuries, CDRH encourages MedSun 
participants to report close calls and user errors voluntarily.   
Manufacturer and User Facility Device Experience Database 
Since 1996, the Manufacturer and User Facility Device Experience 
(MAUDE) database has housed all voluntary and mandatory adverse 
event reports, including reports submitted through MedSun.  CDRH 
analysts use MAUDE to review the adverse event reports and examine 
specific devices adverse event histories as well as those of similar 
devices.  FDA is in the process of replacing MAUDE with the FDA 
Adverse Event Reporting System, which will house adverse event 
 
23 FDA, CDRH.  FY 2006 Annual Report, September 2007.  Available online at 
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm129324.htm.  Last 
accessed on March 12, 2009. 
24 FDA, CDRH.  MedSun:  About MedSun, May 21, 2009.  Available online at 
https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.  Last accessed on 
March 12, 2009. 
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I N T R O D U C T I O N  
information from all five FDA centers.25  CDRH will implement the new 
system at the end of 2010.26  
CDRH Review of Adverse Events 
Each night, MAUDE forwards new reports to CDRH analysts based on 
their specialties, which range from nursing to engineering.  CDRH 
prioritizes the review of adverse event reports moving from the most to 
the least serious: 
  5-day reports (those required to be reported within 5 days of an 
adverse event); 
  Code Blue reports (reports of pediatric deaths, multiple deaths, 
exsanguinations, explosions, fires, burns, electrocutions, and 
anaphylaxis); 
  individual death and serious injury reports (those required to be 
reported within 30 days of an adverse event); and 
  malfunction reports (MAUDE randomly chooses 1 of every        
10 malfunction reports for review). 
Analysts review the devices label, research its history, and analyze 
trends to ensure that the devices warning reflects the adverse event 
and occurs at no greater than the expected rate.  If analysts need more 
information, they may request additional details from the 
manufacturer.27   If a type of event mentioned in the warning occurred  
and the manufacturer took the appropriate response, analysts stop 
researching the adverse event and save the report in the database for 
trending and further use. 
When appropriate, analysts may recommend specific actions based on 
their reviews.  These actions include warning physicians and the public 
about potential health concerns, requiring manufacturers to conduct 
postmarket studies, increasing education and outreach to 
manufacturers and user facilities, and consulting with other CDRH 
offices to arrange field investigations.  Analysts also may exchange 
 
25 The five FDA centers are CDRH, the Center for Drug Evaluation and Research, the 
Center for Biologics Evaluation and Research, the Center for Food Safety and Applied 
Nutrition, and the Center for Veterinary Medicine. 
26 FDA, CDRH.  MedWatch Plus/FAERS.  Available online at 
http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/SpotlightonCPIPro
jects/ucm083295.htm.  Last accessed on March 12, 2009. 
27 21 CFR  803.15. 
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information with premarket reviewers about problems noticed during a 
devices approval, which might assist them in determining whether 
further action is necessary.  In the most serious situations, CDRH may 
request for-cause inspections of the manufacturers.28   
CDRH, through the Office of Compliance, sends all requests for 
manufacturer inspections to FDAs Office of Regulatory Affairs, which 
conducts inspections and recommends classifications.29  However, 
CDRH makes the final decisions regarding classification after reviewing 
the inspection reports.  FDA has several means to protect the public 
from unsafe and ineffective devices, including:30 
  recalling a medical device from the marketplace,31 
  withdrawing and temporarily suspending an approved 
application,32  
  requiring a manufacturer to conduct postmarket surveillance,33 
  levying a civil monetary penalty not to exceed $150,000 per 
event and $1 million per proceeding,34  
  issuing a warning of FDAs intent to seek criminal prosecution,35 
  filing a proceeding to seize a specified device,36 
  seeking an injunction,37 or 
  referring the matter to the appropriate United States Attorney 
for prosecution.38 
 
 
28 A for-cause inspection is based on a previous problem or complaint. 
29 Inspections can result in one of three classifications:  no action indicated, voluntary 
action indicated, or official action indicated.   
30 FDA. Regulatory Procedures Manual, March 2008.  Available online at 
http://www.fda.gov/ora/compliance_ref/rpm/.   Last accessed on March 12, 2009. 
31 21 U.S.C.  360h(e). 
32 21 U.S.C.  360e(e). 
33 21 U.S.C.  360l(a). 
34 21 U.S.C.  333(f)(1). 
35 21 U.S.C.  335. 
36 21 U.S.C.  334(a). 
37 21 U.S.C.  332(a). 
38 21 U.S.C.  333(a). 
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I N T R O D U C T I O N  
METHODOLOGY 
Scope 
This study focused on the universe of reported medical device adverse 
events contained in the MAUDE and ASR databases from 2003 to 2007.  
Data Collection and Analysis  
We used six data sources for this evaluation:   
(1)  MAUDE:  the FDA database containing manufacturer, user facility, 
distributor, and voluntary reports;   
(2)  ASR database:  the FDA database containing reports that 
manufacturers submitted quarterly to FDA;  
(3)  annual user facility reports; 
(4)  CDRH files on compliance and enforcement actions from the Office 
of Compliance about manufacturer inspections and information about 
regulatory actions taken;    
(5)  structured interviews with all 16 CDRH analysts who review 
individual adverse event reports; and 
(6)  interviews with CDRH senior officials. 
Appendix A contains a full description of the methods. 
Limitations 
We did not verify information in the adverse event reports from the user 
facilities or manufacturers.  We also did not calculate the magnitude of 
underreporting from either user facilities or manufacturers.  Finally, 
this report does not make determinations about the appropriateness of 
the analysts decisions or the actions that CDRH took pertaining to any 
adverse event report. 
Standards 
This study was conducted in accordance with the Quality Standards for 
Inspections approved by the Council of the Inspectors General on 
Integrity and Efficiency. 
  OEI-01-08-00110  ADVERSE EVENT REPORTING FOR MEDICAL DEVICES  8   
   
 F I N D I N G S  
 
Overall, FDA received twice as many adverse  Manufacturers, user facilities, 
event reports for medical devices in 2007 than in  distributors, and other voluntary 
reporters, such as consumers and 
2003; however, some types of reports decreased  
physicians, submitted             
72,866 medical device adverse event reports in 2003.  By 2007, that 
number more than doubled to 150,210 reports.  Medical device 
manufacturers submitted the vast majority of these reports.  Between 
2003 and 2007, manufacturer reports increased from 90 to 94 percent of 
all reports.  Reports from user facilities and those from distributors and 
voluntary reporters made up the few remaining reports.  (See Appendix 
B for details.) 
The increase in 30-day manufacturer reports drove the overall increase 
Thirty-day reports of death, serious injury, and malfunction accounted 
for almost 100 percent of manufacturer reports and drove the overall 
increase in adverse event reports.  The remaining manufacturer reports 
were mostly 5-day reports, but also included FDA special requests and 
reports without a classification.  (See Table 2 for details.) 
Five-day reports, resulting from an adverse event that necessitates 
remedial action to prevent a public health risk, made up less than          
1 percent of manufacturer reports.  Although the total number of 
manufacturer reports substantially increased, 5-day reports decreased 
from 432 to 54 reports per year over the 5-year period.  It is unclear why 
the number of reports decreased; however, the decrease might be 
explained by reporters misclassifying the reports, an actual decrease in 
5-day reports, or a combination of the two.   
Table 2:  Manufacturer Adverse Event Reports 20032007 
 
 Type of Manufacturer Reports 2003 2004 2005 2006 2007
 
Thirty-day manufacturer reports 64,784 70,505 89,983 109,527 140,698
    Percentage of total manufacturer reports 100% 100% 100% 100% 100%
Five-day manufacturer reports 432 203 160 134 54
 
   Percentage of total manufacturer reports 1% 0% 0% 0% 0%
 
Other manufacturer reports* 1 10 14 15 313
   Percentage of total manufacturer reports 0% 0% 0% 0% 0%
 
     Total manufacturer reports 65,217 70,718 90,157 109,676 141,065
 
Source:  Office of Inspector General (OIG) analysis of MAUDE adverse event data, 2009. 
Percentages do not add to 100 because of rounding. 
 
* Other manufacturer reports include FDA-requested reports and reports that are missing a classification. 
  OEI-01-08-00110  ADVERSE EVENT REPORTING FOR MEDICAL DEVICES  9   
   
F I N D I N G S  
In addition to submitting individual adverse event reports, 
manufacturers submitted 233 quarterly ASRs in 2007, a slight increase 
from the 209 ASRs they submitted in 2003.  Each ASR may include 
thousands of adverse events that occurred in the preceding quarter.  In 
2003, ASRs contained 91,192 adverse events.  This number increased 
steadily until 2006, when it increased more than fourfold to         
443,066 events, and then stayed relatively flat with 449,978 events in 
2007.  The vast majority of that fourfold increase can be attributed to 
one particular manufacturers device.  That manufacturer started 
reporting adverse events involving this device using ASRs in 2006.  This 
device accounted for 312,625 events in 2006 and 309,918 in 2007. 
MedSun user facilities submitted more reports than all other user facilities 
Through their submission of both mandatory and voluntary reports, the 
MedSun facilities accounted for 78 percent of all user facility adverse 
event reports in 2007.  User facilities include hospitals, ambulatory 
surgical facilities, nursing homes, and outpatient treatment facilities 
that are not physicians offices.  In fact, the large increase in MedSun 
reports caused the total number of user facility reports to increase       
12 percent over the 5 years.  (See Table 3.)  
Table 3:  Non-MedSun and MedSun User Facility Reports 
 
 
  Type of Report 2003 2004 2005 2006 2007
Total non-MedSun reports 2,029 1,592 1,273 879 697
 
Mandatory reports 1,275 1,035 79 596 532
Voluntary reports 754 557 494 283 165
 
Total MedSun reports 861 1,664 2,479 2,169 2,537
 
Mandatory reports 100 308 330 210 251
Voluntary reports 761 1,356 2,149 1,959 2,286
 
     Total user facility
2,890 3,256 3,752 3,048 3,234
      reports
Source:  OIG analysis of MAUDE adverse event data, 2009. 
 
The decrease in and low numbers of reports from non-MedSun facilities 
highlight a potential reporting problem.  Of the roughly 350 MedSun 
facilities, 252 submitted at least one adverse event report in 2007, up 
from 104 facilities in 2003.  (See Table 4.)  Conversely, only                 
267 non-MedSun user facilities out of the thousands of potential user 
facilities submitted reports in 2007, down from 719 in 2003.  Certainly 
some of the discrepancy results from the special attention and training 
MedSun facilities receive, but the low rate of reporting from other 
  OEI-01-08-00110  ADVERSE EVENT REPORTING FOR MEDICAL DEVICES  10   
   
F I N D I N G S  
facilities raises concerns about potential underreporting of adverse 
events. 
Table 4:  User Facilities That Reported Adverse Events 
 Nu mber of User Facilities 
2003 2004 2005 2006 2007
Reporting
 
Total non-MedSun facilities 719 519 458 306 267
 
 Total MedSun facilities 104 192 246 220 252
     Total user facilities
  823 711 704 526 519
     reporting
S ource:  OIG analysis of MAUDE adverse event data, 2009. 
Despite the sharp drop in non-MedSun user facility reporting, CDRH 
has offered little outreach to these user facilities.  CDRH staff are 
available during business hours to answer user facilities reporting 
questions, and the agency posts guidance documents online.  However, 
outreach has been limited to a few conferences in the last 5 years.  
 
Manufacturers submitted most adverse event 
In 2007, manufacturers submitted 
reports on time, but many 5-day manufacturer 
89 percent of all 30-day reports on 
and user facility reports were late  time.  This percentage has 
remained relatively unchanged since 2003, when manufacturers 
submitted 88 percent on time. 
Most 30-day reports were on time, but an increasing number of 5-day 
reports and ASRs were late
Although manufacturers submitted only 54 5-day reports in 2007,            
31 percent of them were late.  This was down from a high of 64 percent in 
2003 but up from 7 percent in 2005.  (See Table 5.)  Manufacturers also 
submitted an increasing percentage of ASRs late.  In 2003, 6 percent of 
ASRs were late, but by 2007, 53 percent were late. 
 
 
 
 
 
 
  OEI-01-08-00110  ADVERSE EVENT REPORTING FOR MEDICAL DEVICES  11   
   
F I N D I N G S  
Table 5: Timeliness of Manufacturer Reports 20032007
 
 
  2003 2004 2005 2006 2007
 Thirty-day manufacturer reports 64,784 70,505 89,983 109,527 140,698
Percentage of reports on time 88% 89% 92% 91% 89%
 
Percentage of reports late 8% 7% 5% 7% 8%
  Percentage of unable to determine 4% 4% 3% 3% 3%
 Emergency 5-day manufacturer reports 432 203 160 134 54
Percentage of reports on time 28% 77% 88% 84% 65%
 
Percentage of reports late 64% 21% 7% 14% 31%
  Percentage of unable to determine 8% 2% 5% 2% 4%
 Other manufacturer reports * 1 10 14 15 313
     Total manufacturer reports 65,217 70,718 90,157 109,676 141,065
 
Source:  OIG analysis of MAUDE adverse event data, 2009. 
 
Percentages do not add to 100 because of rounding. 
*  Other manufacturer reports include FDA-requested reports and reports that are missing classifications. 
User facilities submitted at least 30 percent of adverse event reports late
In 2007, user facilities submitted 39 percent of both death and injury 
adverse event reports late to FDA.  The percentage late ranged from    
30 percent in 2005 to 45 percent in 2006.  (See Table 6.) 
Table 6:  Late User Facility Reports to FDA 20032007 
   
Report Types to FDA 2003 2004 2005 2006 2007
 
 Total death reports in MAUDE 
151 142 99 69 66
to FDA
 
Number late 74 55 37 26 32
 
Percentage late 49% 39% 37% 38% 48%
 
Total injury reports in MAUDE 
627 516 402 305 301
 to FDA
Number late 239 206 115 141 110
 
Percentage late 38% 40% 29% 46% 37%
 
Total death and injury reports 
778 658 501 374 367
 in MAUDE to FDA
Number late 313 261 152 167 142
 
Percentage late 40% 40% 30% 45% 39%
S ource:  OIG analysis of MAUDE adverse event data, 2009. 
Likewise, user facilities submitted at least 42 percent of adverse event 
reports late to manufacturers in each year from 2003 to 2007.  Although 
the number of adverse event reports submitted to manufacturers 
  OEI-01-08-00110  ADVERSE EVENT REPORTING FOR MEDICAL DEVICES  12   
   
F I N D I N G S  
declined from 2003 to 2007, the percentage late stayed relatively flat.  
(See Table 7.)   
Table 7:  Late User Facility Reports to Manufacturers  
20032007 
 
 
Report Types to Manufacturers 2003 2004 2005 2006 2007
 
Total death reports in MAUDE to 
 manufacturers 151 119 95 67 55
Number late 74 51 39 24 29
 
Percentage late 49% 43% 41% 36% 53%
 Total injury reports in MAUDE to  813 675 475 346 335
manufacturers
  Number late 345 305 201 170 141
Percentage late 42% 45% 42% 49% 42%
 Total death and injury reports in 
964 794 570 413 390
MAUDE to manufacturers
  Number late 419 356 240 194 170
Percentage late 43% 45% 42% 47% 44%
 
Source:  OIG analysis of MAUDE adverse event data, 2009. 
 
The adverse event reporting 
CDRH does not use adverse event reports in a 
system enables CDRH to gather 
systematic manner to detect and address safety 
information about potentially 
concerns about medical devices 
hazardous devices that could 
cause either injury or death.  It is not clear, however, the extent to 
which CDRH uses this information to identify and address problems 
with medical devices.  
CDRH has not documented followup on adverse event reports
MAUDE enables analysts to document when they send out additional 
information requests, place a telephone call, recommend an inspection, 
or take other actions during the review of an adverse event report.  In 
practice, however, analysts document little of their reviews, which can 
make it difficult to trace the response to an individual event.  For 
example, analysts reported that they often send requests for additional 
information to manufacturers that omitted pertinent information or 
specific details about the event, yet the analysts documented sending 
requests for only 5 percent of reports in 2007.  
Outcomes of adverse events can result in a variety of postmarket 
surveillance activities, such as public health notifications, warning 
letters, and education of manufacturers and user facilities.  At this time, 
CDRH cannot link these responses to particular adverse events through 
documentation. 
  OEI-01-08-00110  ADVERSE EVENT REPORTING FOR MEDICAL DEVICES  13   
   
F I N D I N G S  
CDRH also lacks an established system to document when adverse 
event reports result in onsite inspections.  Although analysts refer 
adverse event reports to CDRHs Office of Compliance to pursue 
regulatory action, the office does not document which reports resulted in 
inspections.  Between 2003 and 2007, 7 of 130 onsite inspections           
(5 percent) specifically referenced adverse event numbers in their files.  
(See Table 8.)  According to CDRH staff, a single adverse event report 
would not generally prompt an onsite inspection, and the Office of 
Compliances records do not indicate whether the adverse event report 
was the primary reason for the inspection.  
Table 8:  For-Cause Inspections Related to Adverse Event 
Reports 
 
Total '03 
2003 2004 2005 2006 2007
- '07
 
Suspect products or devices 2 12 13 11 4 42
 Inspection sites 2 19 37 62 10 130
 
CDRH establishment inspection reports 
21116 25 4 58
not received
 
Percentage of inspection sites 100% 58% 43% 40% 40% 45%
 
Adverse event report numbers identified 
033 10 7
 in files
Source:  OIG analysis of Office of Compliance files, 2009. 
 
The limited documentation extends to inspection results.  In the Office 
of Compliances files, 58 of 130 inspection files for 2003 to 2007           
(45 percent) did not contain the Establishment Inspection Reports.  (See 
Table 8.)  That report includes observations from the onsite inspection 
and the recommended classification of the inspection.  CDRH was able 
to determine the outcomes of 37 of those 58 inspections by looking in a 
separate database; however, CDRH was unable to provide information 
about the outcomes of the remaining 21 inspections.  CDRHs files also 
indicated that regulatory action resulting from inspections associated 
with adverse events was limited to eight warning letters during that 
time. 
CDRH also does not document onsite inspections in the MAUDE 
database.  Our analysis found that analysts recommended inspections 
for 39 reports.  However, we were unable to match any of those adverse 
event report numbers with onsite inspection files from the Office of 
Compliance.   
  OEI-01-08-00110  ADVERSE EVENT REPORTING FOR MEDICAL DEVICES  14   
   
F I N D I N G S  
The analysts we interviewed reported a need for information about the 
inspections or other corrective actions.  Most analysts (12 of 16) 
reported that the lack of feedback from the Office of Compliance is a 
barrier for them to effectively do their jobs.  They reported that the lack 
of information about the outcomes of their referrals makes it difficult to 
follow up with user facilities and manufacturers.  It also affects how 
analysts might respond to additional adverse event reports from the 
same reporter.  
CDRH does not consistently read adverse event reports for the first time in a 
timely manner 
Of the adverse event reports in MAUDE that were read, analysts read 
fewer than one-third of them for the first time within 30 days and less 
than half within 60 days in every year from 2003 through 2007.  (See 
Table 9.)  The vast majority of the unread reports were malfunction 
reports, and MAUDE assigns only 10 percent of those reports to 
analysts for review.  Failure to review reports in a timely manner may 
result in harm to other consumers if the manufacturer misclassified the 
adverse event (e.g., submitting a 30-day report rather than a 5-day 
report). 
CDRH has procedures for reviewing Code Blue and 5-day reports; 
however, we are unable to verify through CDRHs documents whether it 
met the deadlines laid out in those procedures.  The procedures call for 
a contractor to review and identify these reports.  The contractor then 
notifies by email the appropriate personnel of all Code Blue or 5-day 
reports.  The contractor initially enters these reports into MAUDE 
within 24 hours of receiving them, and they should be ready for the 
analysts to review within 96 hours of their receipt.  Our review of 
MAUDE indicates that analysts first read only 6 percent of 5-day 
reports within 5 days of when the reports were entered in 2007.  From        
2003 to 2006 analysts read less than 1 percent of these reports within   
5 days.  For more detailed information on how soon analysts read 5-day 
reports, see Appendix D. 
 
 
 
 
 
 
  OEI-01-08-00110  ADVERSE EVENT REPORTING FOR MEDICAL DEVICES  15   
   
FFF III NNN DDD III NNN GGG SSS    
Table 9:  Timeliness of FDA Review of Adverse Event Reports 
20032007 
 
 
How Soon the Report Is Read 2003 2004 2005 2006 2007
 
All read reports in MAUDE 48,093 52,294 61,617 86,566 122,469
 
Within 0 to 5 days 0% 0% 0% 0% 0%
Within 6 to 10 days 3% 3% 4% 3% 2%
 
Within 11 to 30 days 29% 23% 30% 27% 21%
  Within 31 to 60 days 14% 12% 8% 12% 18%
After 60 days 54% 61% 58% 58% 59%
 
Source:  OIG analysis of MAUDE adverse event data, 2009. 
P ercentages do not add to 100 because of rounding. 
CDRH rarely acts when manufacturers and user facilities submit reports late 
Analysts told us that they generally forward concerns about timeliness 
to CDRHs Division of Surveillance Systems, which manages reporting 
requirements, only when they notice pervasive problems.  In interviews, 
many analysts told us that they handle concerns about timeliness 
informally by calling the manufacturer.  CDRH senior officials told us 
that they rely on analysts to forward information on lack of timely 
reporting to that division.  When it receives concerns, CDRH may 
schedule a conference with the manufacturer.  If the problems persist, 
CDRH may forward the information to the appropriate district office to 
include in the manufacturers next onsite inspection. 
Inability to obtain complete and usable information in adverse event reports 
and in MAUDE hinders analysts review of reports  
Analysts reported that they are unable to make determinations about 
adverse events as quickly as they would like because of data quality and 
data management obstacles.  Although manufacturers and user 
facilities generally submit the required event description on the report 
form, analysts told us that the description is often too vague to be of use 
in their evaluation.  Almost all adverse event reports from 2003 to 2007 
included an event description, although in 2007 the number of reports 
missing descriptions increased.  We did not evaluate the quality of the 
event descriptions.  Missing or vague information can force analysts to 
spend time tracking down additional information, potentially adding 
weeks or months to the process.  (See Appendix C for details.)  
Analysts also pointed to MAUDE as an impediment to making swift 
decisions.  They told us that they are unable to easily conduct trend 
analysis of adverse events using MAUDE.  Additionally, MAUDE does 
not connect with other CDRH databases, which would facilitate 
  OEI-01-08-00110  ADVERSE EVENT REPORTING FOR MEDICAL DEVICES  16   
   
F I N D I N G S  
researching information such as the current device label.  FDA is in the 
process of migrating to a new system, the FDA Adverse Event Reporting 
System, which may address some of the current MAUDE deficiencies. 
CDRH makes limited use of annual reports 
We identified at least 526 user facilities that should have submitted 
annual reports for 2006, but CDRH could provide only 220 annual 
reports for that year.  We could not determine whether facilities did not 
submit reports or CDRH was unable to supply copies.  Either reason 
suggests that these reports have limited utility for the agency. 
CDRH makes limited use of the annual reports that are submitted.  
Staff use them only to verify that corresponding death reports are in 
MAUDE.  Our analysis confirmed that all 24 deaths from the           
2006 annual reports were in MAUDE.  CDRH officials told us that they 
enter missing death reports from the user facilities into MAUDE but 
generally do not contact the user facilities.  Except for a cover sheet 
with a count of reports, the event information in the annual report 
should be redundant to previously submitted information.
  OEI-01-08-00110  ADVERSE EVENT REPORTING FOR MEDICAL DEVICES  17   
   
R E C O M M E N D A T I O N S  
 R E C O M M E N D A T I O N S  
  
The adverse event reporting system provides both CDRH and 
manufacturers with a means to identify and monitor significant adverse 
events involving medical devices.  Our evaluation found that although 
many manufacturers submitted 30-day adverse events on a timely 
basis, compliance rates for 5-day and user facility reports could be 
improved.  This evaluation highlights CDRHs vulnerabilities in its 
ability to identify and address safety concerns for medical devices. 
CDRH has taken steps to improve its data systems and how it 
communicates.  FDA is in the process of replacing MAUDE with the 
FDA Adverse Event Reporting System, which will store adverse events 
for all five of FDAs centers.  CDRH also recently formed committees 
made up of representatives from across CDRH to discuss how to proceed 
with analyzing adverse events that require followup.  The goals of these 
committees are to improve communication and share information.    
As the number of adverse event reports continues to increase, we 
recognize the challenges of processing a growing workload in a limited 
time while staffing levels remain the same.  Given this challenge, it is 
essential that the review process be as transparent as possible and the 
information about specific adverse events be formally documented in a 
searchable and easily retrieved format.  
In light of our findings, CDRH should: 
Develop a protocol for reviewing adverse event reports that specifically 
addresses the following needs: 
Document followup on adverse events.  CDRH should develop systems 
that reference the actions it takes on particular adverse event reports.  
Communication with manufacturers and user facilities, recommended 
actions, and onsite inspections should be clearly documented in records 
linked by a unique adverse event number.   
In addition, CDRH should consider developing a tracking system to 
follow the outcome of referrals that analysts send to the Office of 
Compliance.  This could enhance the communication between the Office 
of Compliance and the analysts. 
Ensure and document that CDRH is meeting its guidelines for reviewing all 
5-day and Code Blue adverse event reports.  Considerable time can pass 
from the date of the actual event until an analyst reads the report for 
the first time.  Although CDRH cannot control when manufacturers 
submit reports, it can influence how quickly analysts first assess the 
  OEI-01-08-00110  ADVERSE EVENT REPORTING FOR MEDICAL DEVICES  18   
   
R E C O M M E N D A T I O N S  
events and the actions the manufacturers are pursuing.  Following its 
own procedures, which require that contractors initially enter all 
priority reports in MAUDE within 24 hours and analysts read them 
within 96 hours would ensure that CDRH knows whether 
manufacturers took the appropriate steps.   
Follow up with manufacturers that routinely submit reports late or with 
incomplete information.  CDRH should identify and target manufacturers 
and user facilities with a history of noncompliance with adverse event 
submission requirements.   
Enhance outreach strategies to reduce underreporting by user facilities.  To 
increase reporting among non-MedSun user facilities, CDRH should 
consider implementing strategies such as the type of additional training 
and outreach that the MedSun program has used to work effectively 
with its participants to increase reporting.  
Seek legislative authority to eliminate the requirement for user facilities to 
submit annual reports 
Other than a count of total adverse event reports, all of the information 
in the annual reports is redundant to the originally submitted reports.  
Eliminating this requirement (21 U.S.C.  360i(b)(c)) would decrease the 
regulatory burden on user facilities, as well as the review burden on 
CDRH.  Instead, CDRH should emphasize the importance of timely and 
appropriate reporting of all injuries and deaths by user facilities. 
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 
RESPONSE 
FDA agreed with both of our recommendations.  In response to our first 
recommendation, FDA said that CDRH will develop a clear review 
protocol that addresses the needs our report identified.  To achieve this, 
FDA stated that its new FDA Adverse Event database will allow for 
more extensive documentation of followup on adverse events and permit 
FDA to more readily identify late and incomplete reports.  FDA also 
stated that CDRH has developed a tracking system that facilitates 
referrals to the Office of Compliance and follows up on them.  Finally, 
FDA will identify steps it will take to stimulate user facility reporting.  
Because FDA stated that a change in statutory authority would be 
needed to eliminate the requirement to submit annual reports, we 
revised our second recommendation accordingly. 
The complete text of FDA comments appears in Appendix E.
  OEI-01-08-00110  ADVERSE EVENT REPORTING FOR MEDICAL DEVICES  19   
   
 A P P E N D I X ~ A    
 
Detailed Methodology 
Scope 
This study focused on the universe of reported adverse events in the 
Manufacturer and User Facility Device Experience (MAUDE) and 
alternative summary report (ASR) databases from 2003 to 2007.  We 
assessed compliance with reporting requirements for manufacturers 
and user facilities, as well as the timeliness of the review by the Center 
for Device and Radiological Health (CDRH).  We also assessed CDRHs 
use of regulatory actions in instances in which analysts determined that 
the manufacturers did not adequately address the adverse events.   
Data Collection and Analysis  
We used six data sources for this evaluation:  (1) MAUDE, (2) ASR 
database, (3) annual user facility reports, (4) CDRH files on regulatory 
actions, (5) structured interviews with CDRH analysts, and                  
(6) interviews with CDRH senior officials. 
MAUDE 
We analyzed all adverse event reports from January 2003 through 
December 2007 that CDRH stores in MAUDE.  MAUDE contains 
manufacturer, user facility, distributor, and voluntary reports.  An 
adverse event may have multiple follow-up reports in addition to an 
initial report, and each report is referred to as a document.  MAUDE 
contained a total of 563,670 documents for 2003 through 2007.  These 
documents include 518,422 initial reports.  The Food and Drug 
Administration (FDA) sent the data in Access files, which we imported 
and analyzed using SAS.   
Our analysis included all initial reports in MAUDE.  We analyzed them 
to determine when they were read for the first time.  We assessed the 
review status of the reports to identify completed reviews, as well how 
many reports were still unread.  We examined 5-day manufacturer 
reports to compare how soon analysts read these reports for the first 
time versus other reports. 
We used the initial adverse event reports to analyze the timeliness and 
completeness of manufacturer and user facility reports.  We did not 
analyze initial voluntary or distributor reports other than to obtain a 
total number.  We used the report dates to determine timeliness based 
on whether they were 5- or 30-day manufacturer reports or 10-day user 
facility reports.  We further divided our analysis of user facility reports 
  OEI-01-08-00110  ADVERSE EVENT REPORTING FOR MEDICAL DEVICES  20   
   
A P P E N D I X ~ A    
based on whether they were death or serious injury reports.  We did not 
analyze the timeliness of reports that did not fall under those 
categories.   
We analyzed how frequently data were missing from manufacturer and 
user facility reports for information that analysts and CDRH staff told 
us was critical to assessing report completeness.  Finally, we identified 
any documented review activity to determine how many additional 
information request letters CDRH sent out and to provide more 
information on follow-up actions recommended by analysts.    
About 350 user facilities submit reports through the Medical Product 
Safety Network (MedSun).  Certain dates in MedSun, such as dates 
when CDRH receives the report and when an analyst first reviews it, 
are reset when reports are transferred to MAUDE.  To obtain correct 
user facility report dates, we requested all MedSun records from 
January 2003 through December 2007.  We identified which user 
facility reports came through the MedSun system and performed our 
analysis using the MedSun dates. 
ASRs 
We analyzed ASRs that manufacturers submitted to FDA each quarter 
from April 2003 through March 2008 (to account for late reports) 
covering January 2003 through December 2007.  FDA sent us the data 
in Access files, which we imported and analyzed using SAS.  We 
compared the dates when manufacturers submitted the reports to the 
dates of the end of each quarter to evaluate the timeliness of 
manufacturers that chose to submit ASRs.  We also calculated the total 
number of events submitted through ASRs each year.  We performed 
comparisons to determine when CDRH received and reviewed ASRs to 
assess how long it takes CDRH to analyze ASR data. 
Annual Reports 
We requested all annual user facility reports for 2006.  We reviewed the 
report dates user facilities provided to determine the timeliness of the 
reports.  We identified all deaths in the annual reports and attempted to 
find individual death reports in MAUDE.  We also compared the 
number of annual reports with the number of user facilities that 
submitted adverse event reports to MAUDE in 2006 to calculate the 
minimum number of missing annual reports. 
CDRH Regulatory Information 
We requested information from CDRHs Office of Compliance about all 
inspections that were associated with adverse event reports from 
  OEI-01-08-00110  ADVERSE EVENT REPORTING FOR MEDICAL DEVICES  21   
   
A P P E N D I X ~ A    
January 2003 through December 2007.  We also requested any 
information about regulatory actions, such as warning letters, recalls, 
product seizures, and injunctions that FDA had taken relating to 
adverse events.  We reviewed 140 cases in which FDA had initiated 
regulatory action associated with adverse event reports.    
Structured interviews with CDRH analysts 
We conducted structured interviews with all 16 CDRH analysts who 
reviewed adverse event reports from December 2008 through      
January 2009.  We conducted 10 of these interviews in person and 6 by 
phone.  Six of these analysts work in the Patient Safety branch and 
review adverse event reports from MedSun facilities.  The remaining    
10 analysts work in the Product Safety branch and review adverse event 
reports from all other sources. 
We asked analysts how they identify adverse event reports that 
required followup and develop a plan of action to manage them.  We also 
asked them about the strengths of CDRHs current procedures as well 
as opportunities for improvement.   
Interviews with CDRH senior officials 
We interviewed senior CDRH officials both by telephone and in person.  
The interviews covered topics ranging from MAUDE data to CDRHs 
communication with different divisions within the center.  
Limitations 
We did not verify information in the adverse event reports from the user 
facilities or manufacturers.  In addition, we limited our analysis to those 
reports that user facilities and manufacturers submitted to FDA.  We 
did not attempt to calculate the magnitude of underreporting from 
either user facilities or manufacturers.  Finally, we did not make 
determinations about the appropriateness of the analysts decisions or 
the actions that CDRH took pertaining to any adverse event report. 
 
 
  OEI-01-08-00110  ADVERSE EVENT REPORTING FOR MEDICAL DEVICES  22   
   
 A P P E N D I X ~ B  
A P P E N D I X ~ A  
Trends in Adverse Event Reports:  20032007 
 
Table B-1:  Medical Device Adverse Event Reports 20032007 
 
 
Type of Adverse Event Report 2003 2004 2005 2006 2007
Manufacturer reports 65,217 70,718 90,157 109,676 141,065
Percentage of total reports 90% 90% 92% 93% 94%
User facility reports 2,890 3,256 3,752 3,048 3,234
Percentage of total reports 4% 4% 4% 3% 2%
Other reports* 4,759 4,610 4,552 5,571 5,911
Percentage of total reports 7% 6% 4% 5% 4%
     Report total 72,866 78,584 98,461** 118,295** 150,210
Source:  Office of Inspector General analysis of Manufacturer and User Facility Device Experience database 
adverse event data, 2009. 
Percentages do not add to 100 because of rounding. 
* Other reports include FDA voluntary and distributor reports. 
** Totals for 2005 and 2006 do not include one report and five reports, respectively, because information in the 
reports needed for our analysis was missing.
  OEI-01-08-00110  ADVERSE EVENT REPORTING FOR MEDICAL DEVICES  23   
   
  A P P E N D I X ~ C  
 
Adverse Event Reports Missing Critical Information 
For our analysis, we included the manufacturer name; device brand 
name; device generic name; device product code; and, when necessary, 
the device identification numbers.  In situations when more than one 
device may have been involved in the adverse event, we considered a 
report as missing information if any associated device field was missing 
information.  We considered the device information missing when the 
field was blank; specified do not know, no information, or 
unknown; or contained what the Center for Device and Radiological 
Health called invalid data.  We did not consider information missing 
when the field contained not applicable. 
Table C-1:  Adverse Event Reports Missing Critical Information 
 
 
2003 2004 2005 2006 2007
Initial manufacturer reports 65,127 70,718 90,162 109,676 141,065
Percentage missing event description 3% 5% 2% 2% 11%
Percentage missing manufacturer 
2% 1% 1% 1% 1%
name and device brand name
Percentage missing device brand 
2% 1% 1% 1% 1%
name and generic name
Percentage missing any device 
30% 36% 37% 45% 50%
identification number *
Initial user facility reports 2,890 3,256 3,752 3,048 3,234
Percentage missing event description 0% 0% 0% 0% 1%
Percentage missing manufacturer 
9% 8% 6% 5% 3%
name and device brand name
Percentage missing device brand 
3% 3% 2% 2% 2%
name and generic name
Percentage missing any device 
97% 97% 98% 98% 98%
Souidrceen:t i fOicfafitcioen o nf uInmsbpeecr t*or General analysis of MAUDE adverse event data, 2009. 
* Device identification numbers include the model number, lot number, serial number, catalog number, and any 
other identification number.
  OEI-01-08-00110  ADVERSE EVENT REPORTING FOR MEDICAL DEVICES  24   
   
 A P P E N D I X ~ D  
Timeliness of FDA Review of Adverse Event Reports 
 
Table D-1: Food and Drug Administration Review of 5-Day 
Reports 20032007 
 
How Soon the Report Is Read 2003 2004 2005 2006 2007
Read 5-day reports 350 55 31 125 51
Within 0 to 5 days 0% 0% 0% 0% 6%
Within 6 to 10 days 23% 15% 6% 8% 6%
Within 11 to 30 days 61% 69% 13% 70% 59%
Within 31 to 60 days 16% 4% 6% 2% 10%
After 60 days 1% 13% 74% 20% 20%
Source:  Office of Inspector General analysis of Manufacturer and User Facility Device Experience database 
adverse event data, 2009. 
Percentages do not add to 100 because of rounding. 
  OEI-01-08-00110  ADVERSE EVENT REPORTING FOR MEDICAL DEVICES  25  I 
I 
A  P PEN  0  x  E 
Agency Comments 
DEPARTMENT OF HEALTH & HUMAN SERVICES 
Food and Drug Administration 
Silver Spring, MD 20993 
DATE:  September  16,  2009 
TO:  Inspector General 
FROM:  Principal Deputy Commissioner of Food and Drugs 
SUBJECT:  FDA's General Comments to OIG's draft report titled, Adverse Event 
Reporting/or Medical Devices (OEI-OI-08-001O) 
FDA is providing the attached general comments to the Office ofInspector General's 
draft report titled: Adverse Event Reporting/or Medical Devices (OE/-OI-08-0010). 
FDA appreciates the opportunity to review and comment onthis draft report before it is 
published. 
Joshua M~arfstein, M.D. 

Principal  eputy CommIssIOner ofFood and Drugs 

Attachment 
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A P P E N D I X   E  
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This report was prepared under the direction of Joyce Greenleaf, 
Regional Inspector General for Evaluation and Inspections in the 
Boston regional office, and Russell Hereford, Deputy Regional Inspector 
General.   
Danielle Fletcher served as the team leader for this study.  Other 
principal Office of Evaluation and Inspections staff from the Boston 
regional office who contributed to the report include Rose Lichtenstein; 
central office staff who contributed include Talisha Searcy.  
 
 
  OEI-01-08-00110  ADVERSE EVENT REPORTING FOR MEDICAL DEVICES  29