Reported Reactions

Devices › Dressing, wound, occlusive

Device brand name · Dressing wound occlusive

Duoderm: medical device reports filed with FDA

10,758 reports name it, 2022–2026. Manufacturer given most often on reports: Convatec Dominican Republic. Product code NAD.

10,758
device reports naming the brand
0% of all MAUDE reports · about 2,750 a year
5,527
reports, 12 months to August 2026
2,561 in the 12 months before
100%
classified as malfunction
95.1% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 10,758 reports that name the brand "Duoderm" (dressing wound occlusive), received between August 2022 and August 2026; the manufacturer given most often on reports is Convatec Dominican Republic. Spellings of one product vary from report to report.

5,527 reports arrived in the 12 months to August 2026, up 116% from 2,561 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 (100%); across all dressing, wound, occlusive reports (product code NAD) death is recorded in 0% and malfunction in 95.1%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are delivered as unsterile product (92.6%), contamination /decontamination problem (89.2%) and device damaged prior to use (5.5%). The patient problems coded most often are tissue breakdown, skin tears and skin inflammation/ irritation. 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."

Reports by month, five years

01,5843,167Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 2Sep 2022: 88Oct 2022: 78Nov 2022: 14Dec 2022: 102023Jan 2023: 6Feb 2023: 5Mar 2023: 5Apr 2023: 10May 2023: 8Jun 2023: 27Jul 2023: 3Aug 2023: 23Sep 2023: 445Oct 2023: 780Nov 2023: 204Dec 2023: 312024Jan 2024: 36Feb 2024: 111Mar 2024: 185Apr 2024: 32May 2024: 14Jun 2024: 85Jul 2024: 205Aug 2024: 263Sep 2024: 504Oct 2024: 280Nov 2024: 28Dec 2024: 72025Jan 2025: 396Feb 2025: 465Mar 2025: 95Apr 2025: 289May 2025: 225Jun 2025: 144Jul 2025: 49Aug 2025: 79Sep 2025: 341Oct 2025: 72Nov 2025: 287Dec 2025: 1652026Jan 2026: 271Feb 2026: 55Mar 2026: 50Apr 2026: 196May 2026: 97Jun 2026: 30Jul 2026: 796Aug 2026: 3,167

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

By year received

02,3314,6622022: 19220222023: 1,54720232024: 1,75020242025: 2,60720252026: 4,6622026

Event type and report source

Event type, as classified on the report

Death0%0
Injury0%2
Malfunction100%10,756
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%10,758
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 18,954 reports carrying product code NAD. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Delivered as unsterile product9,96392.6%59.7%
Contamination /decontamination problem9,59489.2%51.3%
Device damaged prior to usethe device was damaged before use5975.5%3.2%
Tear, rip or hole in device packaging3663.4%2.1%
Unsealed device packaging3152.9%4.3%
Packaging problem3132.9%2.7%
Difficult to removethe device was hard to remove1891.8%2.1%
Device damaged prior to receipt by user1631.5%0.9%
Nonstandard device890.8%0.7%
Material disintegration780.7%0.7%
Device contaminated during manufacture or shipping360.3%0.9%
Material separation160.1%0.2%
Migrationthe device moved from where it was placed50%0%
Material discolored40%0%
Microbial contamination of device40%0%
Activation, positioning or separation problem10%0%
Device handling problem10%0%
Device misassembled during manufacturing /shipping10%0%
Flare or flash10%0%
Improper or incorrect procedure or method10%0%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)ReportsShare
Tissue breakdown790.7%
Skin tears630.6%
Skin inflammation/ irritation260.2%
Discomfortdiscomfort180.2%
Distress140.1%
Hemorrhage/blood loss/bleeding140.1%
Erythemaskin redness130.1%
Rashskin rash120.1%
Laceration(s)110.1%
Painpain, site not specified40%
Hypersensitivity/allergic reaction30%
Bruise/contusion20%
Abrasion10%
Blistera blister10%
Burning sensationa burning feeling10%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureDuodermProduct code NADAll MAUDE reports
Reports10,75818,95426,136,888
Share of that pool—56.8%0%
Classified as death, per 1,000 reports009
Classified as injury0%4.8%36.2%
Classified as malfunction100%95.1%62.3%
Filed by the manufacturer100%99.6%94.9%

Shares are of reports, not of devices in use. 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."

Other brands with product code NAD

BrandReportsLatest 12 monthsClassified as death
Duoderm/Granuflex/Duoactive - Moisture Retentive Duoderm Cgf Dressing6,20500%
L3w0750 - Duoderm29300%
Aquacel Foam4891240%
Equate317370.3%
Iv3000 1 Hand 6x7cm Ctn 10015730%
Opsite Flexifix Gentle 5cmx5m20600%
EnCor Biopsy Probe5,264150%
Renasys Go Npwt Device20100%

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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Duoderm reports

How many FDA reports name Duoderm?

10,758 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 5,527 in the latest 12 months.

What kinds of events are reported?

malfunction (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

delivered as unsterile product (92.6%), contamination /decontamination problem (89.2%), device damaged prior to use (5.5%), tear, rip or hole in device packaging (3.4%) and unsealed device packaging (2.9%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Duoderm was at fault?

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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.