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 In this section:

                Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities

Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities

                        About Manufacturer and User Facility Device Experience (MAUDE)
          Medical Device Reporting Regulation History


                        eMDR – Electronic Medical Device Reporting
          MDR Adverse Event Codes Home
          Medical Devices
          Device Advice: Comprehensive Regulatory Assistance
          Postmarket Requirements (Devices)
          Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities
          About Manufacturer and User Facility Device Experience (MAUDE)Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities About Manufacturer and User Facility Device Experience (MAUDE)
  
  	
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    PrintManufacturer and User Facility Device Experience (MAUDE) database represents reports of adverse events involving medical devices.

The searchable database contains the last 10 years of medical device report (MDR) data. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19. The downloadable data files consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996.

The public may search the database for information on medical devices that may have malfunctioned or caused a death or serious injury. Data for the past 10 years is available through the end of the previous month. The FDA seeks to include all reports received prior to each monthly update. The inclusion of some reports may be delayed by technical or clerical difficulties.

Data more than 10 years old through 1995 is available in zip files as listed below by year.

MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices. The FDA reviews all medical device reports (MDRs) received. The FDA's analysis of MDRs evaluates the totality of information provided in the initial MDR as well as any MDR supplemental reports subsequently provided. The submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event. For example, in certain MDRs, the text of the report may include the word "death" or a related term. However, the MDR would not, and should not, be classified as death unless the reporter believes the patient's cause of death was or may have been attributed to the device or the device was or may have been a factor in the death.

In addition, although MDRs are a valuable source of information, this passive surveillance system has limitations. The incidence, prevalence, or cause of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources.

Please be aware that reports regarding device trade names may have been submitted under different manufacturer names. Searches only retrieve records that contain the search term(s) provided by the requester.

The data is also available in zipped files for downloading. The data in zip files is updated on a monthly basis.

These files were then compressed ("zipped") in order to save space. For these files to be useful to you, you'll first have to download them, unzip them, and then import them into a database or word processor for your further processing.

**DISCLAIMER:** Section 21 CFR 803.16 explains that a report or other information submitted by a reporting entity under this part, and any release by FDA of that report or information, does not necessarily reflect  an admission that the device, or the reporting entity or its employees, caused or contributed to the reportable event. The reporting entity need not admit and may deny that the report or information submitted under this part constitutes an admission that the device, the party submitting the report, or employees thereof, caused or contributed to a reportable event. In addition, some firms have submitted their own additional disclaimer statements.

The releasable MAUDE data is presented in four logical records types. For this data to be meaningful, you should download all four types of files. The four record formats contain all releasable information on MEDWATCH Form 3500.

**Downloading Hint:** When downloading the MAUDE data files to a database such as Microsoft Access, it is recommended that you first open, then save the data file in Microsoft Word. This will add an "end of record" marker to each MAUDE record that can be recognized by Microsoft ACCESS. For files such as the FOIDEV files, you may need to put in an extra character at the end of the first record prior to importing the file, otherwise the last column of data may be lost.

**Master Event Data:** A distinct master event data record will be present for each source reporting an event. In other words, if a User Facility, Distributor, Manufacturer, and voluntary submitter all report an event, there will be four event records.

**Device Data:** Record Type 2 contains information related to the device(s) involved in the event.

**Patient Data:**Record Type 3 contains information related to the patient(s) involved in the event.

**Text Data:** Record Type 4 contains textual information from MEDWATCH Form Sections B5, H3, and H10.

All record types are linked via the MDR REPORT KEY.

For distributor reports which have had subsequent manufacturer reports, a special data element, MANUFACTURER LINK FLAG, will be set to 'Y'. In this case, the DISTRIBUTOR information (Section F on the master event data record) will be present; otherwise, these data elements will be blank.

The following files are available: (File Sizes are approximate)

File Name
			Compressed
			Size in Bytes
			Uncompressed
			Size in Bytes
			Total Recordsmdrfoi.zip
			58880KB
			560954KB
			1766723
			MAUDE Base records received to date for 2023mdrfoithru2023.zip
			598951KB
			5800337KB
			18118160
			Master Record through 2023mdrfoiadd.zip
			6052KB
			57102KB
			179856
			New MAUDE Base records for the current month.mdrfoichange.zip
			27210KB
			267107KB
			786149
			MAUDE Base data updates: changes to existing Base data.patient.zip
			9439KB
			71703KB
			1766486
			MAUDE Patient records received to date for 2023patientthru2023.zip
			95312KB
			687674KB
			18104231
			Patient Record through 2023patientadd.zip
			980KB
			7363KB
			179802
			New MAUDE Patient records for the current month.patientchange.zip
			4710KB
			32258KB
			785692
			MAUDE Patient data updates: changes to existing Base data.patientproblemcode.zip
			127591KB
			1229424KB
			17844128
			MAUDE Patient records for problemcodepatientproblemdata.zip
			11KB
			25KB
			998
			Patient Problem Datafoidevthru1997.zip
			6001KB
			31217KB
			136917
			Device Data through 1997foidev1998.zip
			3205KB
			17539KB
			63440
			Device Data for 1998foidev1999.zip
			2764KB
			14798KB
			52880
			Device Data for 1999device2000.zip
			1932KB
			9998KB
			53114
			Device Data for 2000device2001.zip
			2126KB
			11075KB
			59073
			Device Data for 2001device2002.zip
			2321KB
			12967KB
			70384
			Device Data for 2002device2003.zip
			2527KB
			14242KB
			77949
			Device Data for 2003device2004.zip
			2803KB
			14944KB
			82887
			Device Data for 2004device2005.zip
			3350KB
			17711KB
			99770
			Device Data for 2005device2006.zip
			3966KB
			21308KB
			120486
			Device Data for 2006device2007.zip
			4820KB
			30277KB
			172205
			Device Data for 2007device2008.zip
			5521KB
			34034KB
			195474
			Device Data for 2008device2009.zip
			6724KB
			43739KB
			243108
			Device Data for 2009device2010.zip
			8724KB
			56054KB
			304407
			Device Data for 2010device2011.zip
			11585KB
			80802KB
			446880
			Device Data for 2011device2012.zip
			13376KB
			88104KB
			487770
			Device Data for 2012device2013.zip
			17746KB
			124537KB
			682402
			Device Data for 2013device2014.zip
			20349KB
			159694KB
			863841
			Device Data for 2014device2015.zip
			23406KB
			169708KB
			862910
			Device Data for 2015device2016.zip
			26283KB
			180365KB
			868406
			Device Data for 2016device2017.zip
			31495KB
			206501KB
			938709
			Device Data for 2017device2018.zip
			37401KB
			236929KB
			1050565
			Device Data for 2018device2019.zip
			45758KB
			307569KB
			1333416
			Device Data for 2019device2020.zip
			50434KB
			362346KB
			1567507
			Device Data for 2020device2021.zip
			60622KB
			460511KB
			2031066
			Device Data for 2021device2022.zip
			73404KB
			658110KB
			2949597
			Device Data for 2022device2023.zip
			72164KB
			528326KB
			2340887
			Device Data for 2023device.zip
			53709KB
			398661KB
			1767182
			Device Data received to date for 2023deviceadd.zip
			5603KB
			39637KB
			179835
			New MAUDE Device data for the current month.devicechange.zip
			25572KB
			194107KB
			786446
			Device data updates: changes to existing Device data and additional Device data for existing Base records.deviceproblemcodes.zip
			16KB
			42KB
			1704
			Device Problem Datafoidevproblem.zip
			46548KB
			256369KB
			18041237
			Device Data for foidevproblemfoitextthru1995.zip
			3561KB
			16551KB
			27401
			Narrative data through 1995foitext1996.zip
			2782KB
			9318KB
			32059
			Narrative Data for 1996foitext1997.zip
			7557KB
			26382KB
			91009
			Narrative Data for 1997foitext1998.zip
			5924KB
			20773KB
			68316
			Narrative Data for 1998foitext1999.zip
			4501KB
			15788KB
			51119
			Narrative Data for 1999foitext2000.zip
			4760KB
			16491KB
			52625
			Narrative Data for 2000foitext2001.zip
			5090KB
			17763KB
			57986
			Narrative Data for 2001foitext2002.zip
			6089KB
			22304KB
			64859
			Narrative Data for 2002foitext2003.zip
			6221KB
			23332KB
			66241
			Narrative Data for 2003foitext2004.zip
			6090KB
			21742KB
			56117
			Narrative Data for 2004foitext2005.zip
			9649KB
			34692KB
			95044
			Narrative Data for 2005foitext2006.zip
			20092KB
			69183KB
			177414
			Narrative Data for 2006foitext2007.zip
			25177KB
			88484KB
			232627
			Narrative Data for 2007foitext2008.zip
			28286KB
			101218KB
			264972
			Narrative Data for 2008foitext2009.zip
			40869KB
			147687KB
			388042
			Narrative Data for 2009foitext2010.zip
			62269KB
			252984KB
			635654
			Narrative Data for 2010foitext2011.zip
			94583KB
			425073KB
			1040278
			Narrative Data for 2011foitext2012.zip
			108957KB
			475208KB
			1167621
			Narrative Data for 2012foitext2013.zip
			139507KB
			622562KB
			1609332
			Narrative Data for 2013foitext2014.zip
			164295KB
			788040KB
			1948365
			Narrative Data for 2014foitext2015.zip
			184834KB
			861735KB
			2073784
			Narrative Data for 2015foitext2016.zip
			194760KB
			924811KB
			2180342
			Narrative Data for 2016foitext2017.zip
			216542KB
			1076108KB
			2365719
			Narrative Data for 2017foitext2018.zip
			260992KB
			1351216KB
			2826706
			Narrative Data for 2018foitext2019.zip
			315226KB
			1759125KB
			3441119
			Narrative Data for 2019foitext2020.zip
			327827KB
			1975465KB
			3982704
			Narrative Data for 2020foitext2021.zip
			375867KB
			2220111KB
			4802258
			Narrative Data for 2021foitext2022.zip
			354865KB
			2632509KB
			5927375
			Narrative Data for 2022foitext2023.zip
			306475KB
			2173130KB
			4228146
			Narrative Data for 2023foitext.zip
			228840KB
			1624064KB
			3191200
			Narrative Data received to date for 2023foitextadd.zip
			23518KB
			165967KB
			319976
			New MAUDE Narrative data for the current month.foitextchange.zip
			188661KB
			1399243KB
			2181875
			Narrative data updates: changes to existing narrative data and additional narrative data for existing base records.



[Accessibility]

**Note**: This documentation is intended to be used in conjunction with a copy of Medwatch Form 3500A and 3500.

**Record/Data Characteristics:**

The data has one record per line, with the data fields in a pipe-delimited, (i.e., "|") format
	All data elements are alpha-numeric
	All text fields contain whatever data was provided/entered. If no information was provided/entered the field will be left empty. If an asterisk ("*") is present, it represents what was entered on the 3500/3500A.
	All "FLAG" data elements have the value of "Y" for Yes, "N" for No, or are blank if no data was available/entered.
	All fields identified as multiply-occurring represent data elements which may have multiple values. Each value will be present in the field, separated by a comma. The word "OTHER" may appear as one of the values if the "Other" box was checked off. If the whole field is blank, no data was reported/entered.
	Section G CONTACT address information may not necessarily be the address where the device is manufactured.**Special Note for REPORT NUMBER data element:**

The REPORT NUMBER data element represents Manufacturer Report Number, Distributor Report Number, or internally-generated voluntary report number, depending on the source of the record.

This REPORT NUMBER field will be blank when:

User Facility submitted the report
	Distributor report has not been followed by a subsequent Manufacturer report.**Special Notes for Voluntary Reports and User Facility Malfunction Reports:**

The only data elements which will be present on the Master Event Record will be:

NEW RECORD
	DEVICE EVENT KEY
	REPORT SOURCE CODE
	MDR REPORT KEY
	Section BAll other data elements will be blank.

**MDRFOI** file contains following 82 fields, delimited by pipe (|), one record per line:

1. MDR Report Key
2. Empty field (not used)
3. Report Number
4. Report Source Code

P = Voluntary report
U = User Facility report
D = Distributor report
M = Manufacturer report

5. Manufacturer Link Flag (internal information flag)
6. Number Devices in Event (if source code is 'P', field will be null)
7. Number Patient in Event (if source code is 'P', field will be null)
8. Date Received

SECTION-B

9. Adverse Event Flag (B1)
10. Product Problem Flag (B1)
11. Date Report (B4)
12. Date of Event (B3) -- new added, 2006
13. Single Use Flag (Reprocessor Flag) (D8) -- new added, 2006
14. Reporter Occupation Code (E3) -- new added, 2006

* INVALID DATA
000 OTHER
001 PHYSICIAN
002 NURSE
003 NON-HEALTHCARE PROFESSIONAL
0HP HEALTH PROFESSIONAL
0LP LAY USER/PATIENT
100 OTHER HEALTH CARE PROFESSIONAL
101 AUDIOLOGIST
102 DENTAL HYGIENIST
103 DIETICIAN
104 EMERGENCY MEDICAL TECHNICIAN
105 MEDICAL TECHNOLOGIST
106 NUCLEAR MEDICINE TECHNOLOGIST
107 OCCUPATIONAL THERAPIST
108 PARAMEDIC
109 PHARMACIST
110 PHLEBOTOMIST
111 PHYSICAL THERAPIST
112 PHYSICIAN ASSISTANT
113 RADIOLOGIC TECHNOLOGIST
114 RESPIRATORY THERAPIST
115 SPEECH THERAPIST
116 DENTIST
117 NURSE PRACTITIONER

300 OTHER CAREGIVERS
301 DENTAL ASSISTANT
302 HOME HEALTH AIDE
303 MEDICAL ASSISTANT
304 NURSING ASSISTANT
305 PATIENT
306 PATIENT FAMILY MEMBER OR FRIEND
307 PERSONAL CARE ASSISTANT
400 SERVICE AND TESTING PERSONNEL
401 BIOMEDICAL ENGINEER
402 HOSPITAL SERVICE TECHNICIAN
403 MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
404 PHYSICIST
405 SERVICE PERSONNEL
499 DEVICE UNATTENDED
500 RISK MANAGER
501 ADMINISTRATOR/SUPERVISOR
600 ATTORNEY
999 UNKNOWN
NA NOT APPLICABLE
NI NO INFORMATION
UNK UNKNOWN

SECTION-E (if source code is 'P', Section E to H will contain no data)

15. Health Professional (E2)
16. Initial Report to FDA (E4)

Y = Yes
N = No
U = Unknown
* = No answer provided

SECTION-F

17. Date Facility Aware (F6)

18. Report Date (F8)
19. Report to FDA (F11)
20. Date Report to FDA (F11)
21. Event Location (F12)
22. Date Report to Manufacturer (F13)

SECTION-G (only for report source 'M', others sources will be null)

23. Manufacturer Contact Title Name (G1)
24. Manufacturer Contact First Name (G1)
25. Manufacturer Contact Last Name (G1)
26. Manufacturer Contact Street 1 (G1)
27. Manufacturer Contact Street 2 (G1)
28. Manufacturer Contact City (G1)
29. Manufacturer Contact State Code (G1)
30. Manufacturer Contact Zip Code (G1)
31. Manufacturer Contact Zip Code Ext (G1)
32. Manufacturer Contact Country Code
33. Manufacturer Contact Postal Code
34. Manufacturer Contact Phone No Area Code (G1)
35. Manufacturer Contact Phone No Exchange (G2)
36. Manufacturer Contact Phone No (G2)
37. Manufacturer Contact Phone No Ext (G2)
38. Manufacturer Contact Phone No Country Code
39. Manufacturer Contact Phone No City Code
40. Manufacturer Contact Phone No Local
41. Manufacturer G1 Name (G1)
42. Manufacturer G1 Street 1 (G1)
43. Manufacturer G1 Street 2 (G1)
44. Manufacturer G1 City (G1)
45. Manufacturer G1 State Code (G1)
46. Manufacturer G1 Zip Code (G1)
47. Manufacturer G1 Zip Code Ext (G1)
48. Manufacturer G1 Country Code
49. Manufacturer G1 Postal Code
50. Date Manufacturer Received (G4)

SECTION-H
51. Device Date Of Manufacture (H4)
52. Single Use Flag (H5)
53. Remedial Action (H7) -- multiple source type, separate by ','

RC = Recall
RP = Repair
RL = Replace
RB = Relabeling
OT = Other
NO = Notification
IN = Inspection
PM = Patient Monitoring
MA = Modification/Adjustment
* = Invalid Data

54. Previous Use Code (H8)
55. Removal/Correction Number (H9)
56. Event type (H1) -- only relevant for report sourcetype 'M'

D = Death
IN = Injury
IL = Injury
IJ = Injury
M = Malfunction
O = Other
* = No answer provided

57. Distributor Name (F3) -- if report source code = 'M' and
58. Distributor Address line 1 (F3)
59. Distributor Address line 2 (F3)
60. Distributor City (F3)
61. Distributor State Code (F3)
62. Distributor Zip Code (F3)
63. Distributor Zip Code Ext (F3)
64. Report to Manufacturer (F13)
65. Manufacturer Name (F14)
66. Manufacturer Address line 1 (F14)
67. Manufacturer Address line 2 (F14)
68. Manufacturer City (F14)
69. Manufacturer State Code (F14)
70. Manufacturer Zip Code (F14)
71. Manufacturer Zip Code Ext (F14)
72. Manufacturer Country Code (F14)
73. Manufacturer Postal Code (F14)
74. Type of Report (F7) !multiple submission type, separate by ','

I = Initial submission
F = Followup
X = Extra copy received
O = Other information submitted

75. Source Type (G3) -- multiple source type, separate by ','

00 Other
01 Foreign
02 Study
03 Literature
04 Consumer
05 Health Professional
06 User facility
07 Company representation
08 Distributor
99 Unknown
* Invalid data

76. Date Added
77. Date Changed
78. Reporter Country Code
79. PMA PMN Number
80. Exemption Number
81. Summary Report
82. NOE Summary

**DEVICE** file contains following 48 fields, delimited by pipe (|), one record per line:

1. MDR Report Key
2. Device Event key
3. Implant Flag -- D6, new added; 2006
4. Date Removed Flag -- D7, new added; 2006; if flag in M or Y, print Date

U = Unknown
A = Not available
I = No information at this time
M = Month and year provided only, day defaults to 01
Y = Year provided only, day defaulted to 01, month defaulted to January

5. Device Sequence No -- from device report table
6. Date Received (from mdr_document table)

SECTION-D

7. Brand Name (D1)
8. Generic Name (D2)
9. Manufacturer Name (D3)
10. Manufacturer Address 1 (D3)
11. Manufacturer Address 2 (D3)
12. Manufacturer City (D3)
13. Manufacturer State Code (D3)
14. Manufacturer Zip Code (D3)
15. Manufacturer Zip Code ext (D3)
16. Manufacturer Country Code (D3)
17. Manufacturer Postal Code (D3)
18. Device Operator (D5)
19. Expiration Date of Device (D4)
20. Model Number (D4)
21. Catalog Number (D4)
22. Lot Number (D4)
23. Other ID Number (D4)
24. Device Availability (D10)

Y = Yes
N = No
R = Device was returned to manufacturer
* = No answer provided

25. Date Returned to Manufacturer (D10)
26. Device Report Product Code
27. Device Age (F9)
28. Device Evaluated by Manufacturer (H3)

Y = Yes
N = No
R = Device not returned to manufacturer
* = No answer provided

BASELINE SECTION (for records prior to 2009)
29. Baseline brand name
30. UDI-DI (D4)
31. UDI-Public (D4)
32. Baseline generic name
33. Baseline model no
34. Baseline catalog no
35. Baseline other id no
36. Baseline device family
37. Baseline shelf life contained in label

Y = Yes
N = No
A = Not applicable
* = No answer provided

38. Baseline shelf life in months
39. Baseline PMA flag
40. Baseline PMA no
41. Baseline 510(k) flag
42. Baseline 510(k) no
43. Baseline preamendment
44. Baseline transitional
45. Baseline 510(k exempt flag
46. Baseline date) first marketed
47. Baseline date ceased marketing

**PATIENT** file contains following 5 fields, delimited by pipe (|), one record per line:

1. MDR Report Key (from patient report table)
2. Patient Sequence Number (from patient report table)
3. Date Received (from mdr_document table)
4. Sequence Number||','|| Treatment -- multiple source type, separate by ';'
5. Sequence Number||','|| Outcome -- multiple source type, separate by ';'

L - Life Threatening
H - Hospitalization
S - Disability
C - Congenital Anomaly
R - Required Intervention
O - Other
* - Invalid Data
U - Unknown
I - No Information
A - Not Applicable
D - Death

6. Patient Age
7. Patient Sex or Gender
8. Patient Weight
9. Patient Ethnicity
10. Patient Race

**TEXT** file contains following 6 fields, delimited by pipe (|), one record per line:

1. MDR Report Key
2. MDR Text Key
3. Text Type Code (D=B5, E=H3, N=H10 from mdr_text table)
4. Patient Sequence Number (from mdr_text table)
5. Date Report (from mdr_text table)
6. Text (B5, or H3 or H10 from mdr_text table)

**FOIDEVPROBLEM** contains 2 fields, delimited by pipe (|), one record per line:
1. Device Problem Code
2. Problem Description

**DEVICEPROBLEMCODES** contains 2 fields, delimited by pipe (|), one record per line:
1. MDR Report Key
2. Device Problem Code -- (F10) new added; 2006

**PATIENTPROBLEMDATA** contains following 2 fields, delimited by pipe (|), one record per line:
1. Patient Problem Code
2. Problem Description

**PATIENTPROBLEMCODE** contains following 2 fields, delimited by pipe (|), one record per line:
1. MDR Report Key
2. Patient Problem Code

Device Operator Code Key

* INVALID DATA
0 OTHER
1 PHYSICIAN
2 NURSE
3 NON-HEALTHCARE PROFESSIONAL
0HP HEALTH PROFESSIONAL
0LP LAY USER/PATIENT
100 OTHER HEALTH CARE PROFESSIONAL
101 AUDIOLOGIST
102 DENTAL HYGIENIST
103 DIETICIAN
104 EMERGENCY MEDICAL TECHNICIAN
105 MEDICAL TECHNOLOGIST
106 NUCLEAR MEDICINE TECHNOLOGIST
107 OCCUPATIONAL THERAPIST
108 PARAMEDIC
109 PHARMACIST
110 PHLEBOTOMIST
111 PHYSICAL THERAPIST
112 PHYSICIAN ASSISTANT
113 RADIOLOGIC TECHNOLOGIST
114 RESPIRATORY THERAPIST
115 SPEECH THERAPIST
116 DENTIST
117 NURSE PRACTIONER

300 OTHER CAREGIVERS
301 DENTAL ASSISTANT
302 HOME HEALTH AIDE
303 MEDICAL ASSISTANT
304 NURSING ASSISTANT
305 PATIENT
306 PATIENT FAMILY MEMBER OR FRIEND
307 PERSONAL CARE ASSISTANT
400 SERVICE AND TESTING PERSONNEL
401 BIOMEDICAL ENGINEER
402 HOSPITAL SERVICE TECHNICIAN
403 MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
404 PHYSICIST
405 SERVICE PERSONNEL
499 DEVICE UNATTENDED
500 RISK MANAGER
501 ADMINISTRATOR/SUPERVISOR
600 ATTORNEY
999 UNKNOWN
NA NOT APPLICABLE
NI NO INFORMATION
UNK UNKNOWN

Event Location Code Key

* INVALID DATA
000 OTHER
001 HOSPITAL
002 HOME
003 NURSING HOME
004 OUTPATIENT TREATMENT FACILITY
005 OUTPATIENT DIAGNOSTIC FACILITY
006 AMBULATORY SURGICAL FACILITY
500 HOSPITAL
501 CATHETERIZATION SUITE
502 CRITICAL CARE UNIT
503 DIALYSIS UNIT
504 EMERGENCY ROOM
505 EXAMINATION ROOM
506 LABORATORY/PATHOLOGY DEPARTMENT
507 MATERNITY WARD - NURSERY
508 OPERATING ROOM
509 OUTPATIENT CLINIC/SURGERY
510 PATIENT'S ROOM OR WARD
511 RADIOLOGY DEPARTMENT
600 AMBULATORY HEALTH CARE FACILITY
601 AMBULATORY SURGICAL CENTER
602 BLOOD BANK
603 BLOODMOBILE
604 CATHETERIZATION LAB - FREE STANDING
605 CHEMOTHERAPY CENTER
606 CLINIC - WALK IN, OTHER
607 DIALYSIS CENTER
608 DRUG CLINIC

609 IMAGING CENTER - MOBILE
610 IMAGING CENTER - STATIONARY
611 LABORATORY
612 MOBILE HEALTH UNIT
613 MRI CENTERS
614 PSYCHIATRIC CENTER - WALK IN, OTHER
615 TUBERCULOSIS CLINIC
616 URGENT CARE CENTER
617 OUTPATIENT DIAGNOSTIC FACILITY
700 LONG-TERM CARE FACILITY
701 HOSPICE
702 NURSING HOME
703 PSYCHIATRIC FACILITY
704 REHABILITATION CENTER
705 RETIREMENT HOME
810 PATIENT'S HOME
820 IN TRANSIT TO USER/MEDICAL FACILITY
830 PUBLIC VENUE
831 OUTDOORS
832 PARK
833 PLAYGROUND
834 PUBLIC BUILDING
835 SCHOOL
836 STREET
999 UNKNOWN
NA NOT APPLICABLE
NI NO INFORMATION
UNK UNKNOWN

                                                                                  Content current as of:
      01/05/2024
              
              
Regulated Product(s)
		 Medical Devices
			  			     			  			     Radiation-Emitting ProductsTopic(s)
			  PostmarketMandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities

          
                        About Manufacturer and User Facility Device Experience (MAUDE)
          Medical Device Reporting Regulation History


                        eMDR – Electronic Medical Device Reporting
          MDR Adverse Event Codes
 
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