Dressing, wound, occlusive: medical device reports filed with FDA

18,954 reports carry this product code, 2004–2026; 9 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

18,954
reports with this product code: 0.1% of all MAUDE reports; 5,587
reports, 12 months to August 2026: 2,623 in the 12 months before; 95.1%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code NAD is FDA's classification for "Dressing, wound, occlusive" (general, Plastic Surgery panel), a class 1 device. 18,954 medical device reports carry this product code, 0.1% of the MAUDE database, from January 2004 to August 2026.

5,587 reports arrived in the 12 months to August 2026, up 113% from 2,623 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (95.1%), injury (4.8%) and other (0.1%). 9 brand names with a page on this site carry this code; the brands table is ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Duoderm	10,757	5,527	0%	100%
Duoderm/Granuflex/Duoactive - Moisture Retentive Duoderm Cgf Dressing	6,189	0	0%	99.8%
L3w0750 - Duoderm	293	0	0%	98.6%
Aquacel Foam	12	124	0%	88.1%
Equate	3	37	0.3%	24%
Iv3000 1 Hand 6x7cm Ctn 100	3	3	0%	93.6%
Opsite Flexifix Gentle 5cmx5m	2	0	0%	97.6%
EnCor Biopsy Probe	1	15	0%	99%
Renasys Go Npwt Device	1	0	0%	86.6%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Convatec Dominican Republic	16,842	88.9%
Smith & Nephew Medical	752	4%
Convatec	406	2.1%
3m Health Care	72	0.4%
3m	23	0.1%
Integra Lifesciences	21	0.1%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0%8

Injury4.8%905

Malfunction95.1%18,019

Other0.1%21

Not given0%1

Who filed

Manufacturer report99.6%18,882

Voluntary report0.3%60

User facility report0%0

Distributor report0%1

Not given0.1%11

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Delivered as unsterile product	11,322	59.7%
Contamination /decontamination problem	9,719	51.3%
Device contamination with chemical or other material	5,776	30.5%
Unsealed device packaging	807	4.3%
Device damaged prior to usethe device was damaged before use	615	3.2%
Packaging problem	520	2.7%
Tear, rip or hole in device packaging	404	2.1%
Difficult to removethe device was hard to remove	403	2.1%
Loss of or failure to bond	168	0.9%
Device damaged prior to receipt by user	166	0.9%
Device contaminated during manufacture or shipping	162	0.9%
Material disintegration	131	0.7%
Nonstandard device	131	0.7%
Insufficient device problem information	122	0.6%
Failure to adhere or bond	84	0.4%
Material integrity problema problem with the device material	71	0.4%
Device operates differently than expectedthe device behaved unexpectedly	53	0.3%
Material separation	29	0.2%
Difficult to open or remove packaging material	23	0.1%
Patient-device incompatibilitythe device did not suit the patient	20	0.1%

Questions about dressing, wound, occlusive reports

What is product code NAD?

FDA's classification code for "Dressing, wound, occlusive", class 1, reviewed by the general, Plastic Surgery panel. Every device report carries the product code of the device involved.

How many reports carry this code?

18,954 reports through August 2026, 5,587 of them in the latest 12 months.

Which brands appear most often?

Duoderm (10,757), Duoderm/Granuflex/Duoactive - Moisture Retentive Duoderm Cgf Dressing (6,189), L3w0750 - Duoderm (293), Aquacel Foam (12) and Equate (3). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." Brands differ in how many are in use, how long they have been sold and how reports are collected.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.