Department of Health and Human Services

OFFICE OF 

INSPECTOR GENERAL 

 

ADVERSE EVENT REPORTING 

FOR MEDICAL DEVICES 

 

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: 

Office of Audit Services 

The Office of Audit Services (OAS) provides auditing services for HHS, either by conducting 

audits with its own audit resources or by overseeing audit work done by others. Audits 

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 

HHS programs and operations. These assessments help reduce waste, abuse, and 

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 

HHS, Congress, and the public with timely, useful, and reliable information on significant 

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 

investigators working in all 50 States and the District of Columbia, OI utilizes its resources 

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 

convictions, administrative sanctions, and/or civil monetary penalties. 

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 OIG’s internal operations. OCIG represents OIG in all civil and 

administrative fraud and abuse cases involving HHS programs, including False Claims Act, 

program exclusion, and civil monetary penalty cases. In connection with these cases, OCIG 

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. 
 

ΔINTRODUCTION EXECUTIVE SUMMARY 

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. 

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EXECUTIVE SUMMARY 

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. 

CDRH’s 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 

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EXECUTIVE SUMMARY 

event reports for the first time within 30 days and less than half within 

60 days in every year from 2003 to 2007. CDRH’s 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 CDRH’s 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. 

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EXECUTIVE SUMMARY 

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. 
Δ TABLE OF CONTENTS 

EXECUTIVE SUMMARY .....................................i

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 

FINDINGS .................................................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 

RECOMMENDATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 

Agency Comments and Office of Inspector General 

Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 

APPENDIXES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 

 A: Detailed Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 

 B: Trends in Adverse Event Reports: 2003–2007 . . . . . . . . . . . . 23 

 C: Adverse Event Reports Missing Critical Information . . . . . . . 24 

 D: Timeliness of FDA Review of Adverse Event Reports . . . . . . 25 

 E: Agency Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 

ACKNOWLEDGMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
 

Δ INTRODUCTION 

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. FDA’s 

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 FDA’s 

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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INTRODUCTION 

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 FDA’s 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. “MedWatch—Reporting 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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INTRODUCTION 

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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INTRODUCTION 

Table 1: Adverse Event Reporting Requirements 

 Source: 21 CFR § 803. 

Who Is Reporting What To Report To Whom To Report When To Report

Events that require remedial 

action to prevent an 

unreasonable risk of 

substantial harm to the public 

health and other types of 

events designated in writing 

by FDA

FDA

Within 5 working days 

of becoming aware of 

the event

Deaths, serious injuries, and 

malfunctions FDA

Within 30 calendar 

days of becoming 

aware of the event

Deaths Manufacturer (if known) 

and FDA

Within 10 working 

days of the event

Serious injuries Manufacturer (if known) 

or FDA

Within 10 working 

days of the event

Annual reports of all adverse 

events the facility reported 

during the past year

FDA Annually (by January 

1st)

edical Device 

Manufacturer

ser Facility

M

U

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 Reporting—Alternative 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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INTRODUCTION 

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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INTRODUCTION 

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 device’s label, research its history, and analyze 

trends to ensure that the device’s 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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INTRODUCTION 

information with premarket reviewers about problems noticed during a 

device’s 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 FDA’s 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 FDA’s 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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INTRODUCTION 

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. 

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Source: Office of Inspector General (OIG) analysis of MAUDE adverse event data, 2009. 

Percentages do not add to 100 because of rounding. 

Δ 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, 

distributors, and other voluntary 

reporters, such as consumers and 

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 2003–2007 

* Other manufacturer reports include FDA-requested reports and reports that are missing a classification. 

T

T

 P

F

 P

O

 P

ype of Manufacturer Reports 2003 2004 2005 2006 2007

hirty-day manufacturer reports 64,784 70,505 89,983 109,527 140,698

ercentage of total manufacturer reports 100% 100% 100% 100% 100%

ive-day manufacturer reports 432 203 160 134 54

ercentage of total manufacturer reports 1% 0% 0% 0% 0%

ther manufacturer reports* 1 10 14 15 313

ercentage of total manufacturer reports 0% 0% 0% 0% 0%

 Total manufacturer reports 65,217 70,718 90,157 109,676 141,065

 O E I - 0 1 - 0 8 - 0 0 11 0 ADVERSE E VENT REPORTING FOR MEDICAL DEVICES 9
 

FINDINGS 

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 manufacturer’s 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

 reports 2,890 3,256 3,752 3,048 3,234

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 

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FINDINGS 

facilities raises concerns about potential underreporting of adverse 

events. 

Table 4: User Facilities That Reported Adverse Events 

Number of User Facilities 

Reporting 2003 2004 2005 2006 2007

Total non-MedSun facilities 719 519 458 306 267

Total MedSun facilities 104 192 246 220 252

 Total user facilities

 reporting 823 711 704 526 519

Source: 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 

reports on time, but many 5-day manufacturer 

and user facility reports were late 

 O E I - 0 1 - 0 8 - 0 0 11 0 ADVERSE E VENT REPORTING FOR MEDICAL DEVICES 11

In 2007, manufacturers submitted 

89 percent of all 30-day reports on 

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. 
 

FINDINGS 

Table 5: Timeliness of Manufacturer Reports 2003–2007

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%

mergencyE 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%

therO manufacturer reports * 1 10 14 15 313

 Total manufacturer reports 65,217 70,718 90,157 109,676 141,065

Source: O MAUDE erse

Percen

IG analysis of adv event data, 2009. 

tages 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 2003–2007 

Report Types to FDA 2003 2004 2005 2006 2007

Total death reports 

to FDA

in MAUDE 151 142 99 69 66

Number late 74 55 37 26 32

Percentage late 49% 39% 37% 38% 48%

Total injury reports 

to FDA

in MAUDE 627 516 402 305 301

Number late

Percentage late

239

38%

206

40%

115

29%

141

46%

110

37%

Total death and injury reports 

in MAUDE to FDA 778 658 501 374 367

Number late 313 261 152 167 142

Percentage late 40% 40% 30% 45% 39%

Source: 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 

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FINDINGS 

declined from 2003 to 2007, the percentage late stayed relatively flat. 

(See Table 7.) 

Table 7: Late User Facility Reports to Manufacturers 

2003–2007 

Report Types to Manufacturers 2003 2004 2005 2006 2007

Total death reports 

manufacturers

in MAUDE to 151 119 95 67 55

Number late 74 51 39 24 29

Percentage late 49% 43% 41% 36% 53%

Total injury reports 

manufacturers

in MAUDE to 813 675 475 346 335

Number late 345 305 201 170 141

Percentage late 42% 45% 42% 49% 42%

Total death and injury reports in 

MAUDE to manufacturers 964 794 570 413 390

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 

system enables CDRH to gather 

information about potentially 

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. 

CDRH does not use adverse event reports in a 

systematic manner to detect and address safety 

concerns about medical devices 

 O E I - 0 1 - 0 8 - 0 0 11 0 ADVERSE E VENT REPORTING FOR MEDICAL DEVICES 13
 

FINDINGS 

CDRH also lacks an established system to document when adverse 

event reports result in onsite inspections. Although analysts refer 

adverse event reports to CDRH’s 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 

Compliance’s 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 

2003 2004 2005 2006 2007 Total '03 

- '07

Suspect products or devices 2 12 13 11 4 42

Inspection sites 2 19 37 62 10 130

CDRH establishment inspection reports 

not received 2 11 16 25 4

Percentage of inspection sites 100% 58% 43% 40% 40% 45%

Adverse event report numbers identified 

in files 0 3 3 1 0

58

7

Source: OIG analysis of Office of Compliance files, 2009.

The limited documentation extends to inspection results. In the Office 

of Compliance’s 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. CDRH’s 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. 

 O E I - 0 1 - 0 8 - 0 0 11 0 ADVERSE E VENT REPORTING FOR MEDICAL DEVICES 14
 

FINDINGS 

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 CDRH’s 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. 

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FINDINGS 

Table 9: Timeliness of FDA Review of Adverse Event Reports 

2003–2007 

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. 

Percentages 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 CDRH’s 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 manufacturer’s 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 

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FINDINGS 

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.

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ΔRECOMMENDATIONS RECOMMENDATIONS 

 

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 CDRH’s 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 FDA’s 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 

 O E I - 0 1 - 0 8 - 0 0 11 0 ADVERSE E VENT REPORTING FOR MEDICAL DEVICES 18
 

RECOMMENDATIONS 

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.

 O E I - 0 1 - 0 8 - 0 0 11 0 ADVERSE E VENT REPORTING FOR MEDICAL DEVICES 19
 

Δ APPENDIX~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 CDRH’s 

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 

 O E I - 0 1 - 0 8 - 0 0 11 0 ADVERSE E VENT REPORTING FOR MEDICAL DEVICES 20
 

APPENDIX~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 CDRH’s Office of Compliance about all 

inspections that were associated with adverse event reports from 

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APPENDIX~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 CDRH’s 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 CDRH’s 

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. 

 O E I - 0 1 - 0 8 - 0 0 11 0 ADVERSE E VENT REPORTING FOR MEDICAL DEVICES 22
 

ΔAPPENDIX~A APPENDIX~B 

Trends in Adverse Event Reports: 2003–2007 

Table B-1: Medical Device Adverse Event Reports 2003–2007 

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.

 O E I - 0 1 - 0 8 - 0 0 11 0 ADVERSE E VENT REPORTING FOR MEDICAL DEVICES 23
 

Δ APPENDIX~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 

Source: Office of Inspector General analysis of MAUDE adverse event data, 2009. 

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 

name and device brand name 2% 1% 1% 1% 1%

Percentage missing device brand 

name and generic name 2% 1% 1% 1% 1%

Percentage missing any device 

identification number * 30% 36% 37% 45% 50%

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 

name and device brand name 9% 8% 6% 5% 3%

Percentage missing device brand 

name and generic name 3% 3% 2% 2% 2%

Percentage missing any device 

identification number * 97% 97% 98% 98% 98%

* Device identification numbers include the model number, lot number, serial number, catalog number, and any 

other identification number.

 O E I - 0 1 - 0 8 - 0 0 11 0 ADVERSE E VENT REPORTING FOR MEDICAL DEVICES 24
 

Δ APPENDIX~D 

Timeliness of FDA Review of Adverse Event Reports 

Table D-1: Food and Drug Administration Review of 5-Day 

Reports 2003–2007 

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. 

 O E I - 0 1 - 0 8 - 0 0 11 0 ADVERSE E VENT REPORTING FOR MEDICAL DEVICES 25
A P PEN 0 x E 

Agency Comments 

DEPARTMENT OF HEALTH & HUMAN SERVICES 

Food and Drug Administration 

Silver Spring, MD 20993 

DATE: 

TO: 

FROM: 

SUBJECT: 

September 16, 2009 

Inspector General 

Principal Deputy Commissioner of Food and Drugs 

FDA's General Comments to OIG's draft report titled, 

Reporting/or Medical Devices (OEI-OI-08-001O) 

Adverse Event 

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 

I 

I· 

OEI·01·08·00110 ADVERSE EVENT REPORTING FOR MEDICAL DEVICES 26 
 

APPENDIX ~ E 

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ΔAPPENDIX E ACKNOWLEDGEMENTS 

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.