Reported Reactions

Devices › Dressing, wound, occlusive

Device brand name · Dressing wound occlusive

L3w0750 - Duoderm: medical device reports filed with FDA

293 reports name it, 2020–2022. Manufacturer given most often on reports: Convatec Dominican Republic. Product code NAD.

293
device reports naming the brand
0% of all MAUDE reports · about 53 a year
0
reports, 12 months to August 2026
0 in the 12 months before
98.6%
classified as malfunction
95.1% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

293 medical device reports received by FDA name the brand "L3w0750 - Duoderm" (dressing wound occlusive); the manufacturer given most often on reports is Convatec Dominican Republic; received from December 2020 to August 2022. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

0 reports arrived in the 12 months to August 2026, and none 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 (98.6%) and injury (1.4%); 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 (74.4%), contamination /decontamination problem (34.8%) and packaging problem (34.5%). The patient problems coded most often are no patient involvement, skin irritation and erythema. 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

01224Sep 2021: 4Oct 2021: 6Nov 2021: 16Dec 2021: 62022Jan 2022: 16Feb 2022: 6Mar 2022: 11Apr 2022: 24May 2022: 6Jun 2022: 15Jul 2022: 10Aug 2022: 6Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 0Apr 2024: 0May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

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

0981952020: 420202021: 19520212022: 942022

Event type and report source

Event type, as classified on the report

Death0%0
Injury1.4%4
Malfunction98.6%289
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%293
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 product21874.4%59.7%
Contamination /decontamination problem10234.8%51.3%
Packaging problem10134.5%2.7%
Unsealed device packaging8629.4%4.3%
Device contaminated during manufacture or shipping4415%0.9%
Device contamination with chemical or other material3712.6%30.5%
Difficult to removethe device was hard to remove258.5%2.1%
Tear, rip or hole in device packaging93.1%2.1%
Melted10.3%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
No patient involvement5619.1%
Skin irritationirritated skin165.5%
Erythemaskin redness155.1%
Painpain, site not specified144.8%
Burning sensationa burning feeling134.4%
Itching sensation134.4%
Reactiona reaction, type not specified124.1%
Swellingswelling124.1%
Peeling62%
Tissue damage62%
Hemorrhage/blood loss/bleeding41.4%
Skin tears41.4%
Tissue breakdown41.4%
Bruise/contusion10.3%
Discomfortdiscomfort10.3%

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

In context

MeasureL3w0750 - DuodermProduct code NADAll MAUDE reports
Reports29318,95426,136,888
Share of that pool—1.5%0%
Classified as death, per 1,000 reports009
Classified as injury1.4%4.8%36.2%
Classified as malfunction98.6%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
Duoderm10,7585,5270%
Duoderm/Granuflex/Duoactive - Moisture Retentive Duoderm Cgf Dressing6,20500%
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 L3w0750 - Duoderm reports

How many FDA reports name L3w0750 - Duoderm?

293 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (98.6%) and injury (1.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

delivered as unsterile product (74.4%), contamination /decontamination problem (34.8%), packaging problem (34.5%), unsealed device packaging (29.4%) and device contaminated during manufacture or shipping (15%). 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 L3w0750 - 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.