DUODERM 187955Recalls & reported problems
Convatec, Purchasing Department · DUODERM XTHIN DRS 10x10CM (1x10PK) NAI · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Convatec DuoDerm wound dressing has 2,250 adverse event reports, with no deaths and no injuries. Most describe dressings delivered unsterile or contaminated, and some describe packaging problems, damage before use, or difficulty removing the dressing. 1 recall is open, from August 2025, because the dressing may have foreign matter on the product.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 2,348
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2,348 adverse event reports that list this exact device (DI 00768455106912), received between Apr 25, 2022 and Sep 30, 2026 — classified as 2,348 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (2,212 reports).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Aug 29, 2025Open, Classified
Wound dressing may have foreign matter on the product.
Z-0160-2026 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Delivered as Unsterile Product2,212
- Contamination /Decontamination Problem2,208
- Difficult to Remove84
- Device Damaged Prior to Use50
- Nonstandard Device39
- Packaging Problem33
- Device Contaminated During Manufacture or Shipping17
- Unsealed Device Packaging13
Patient problems
- No Clinical Signs, Symptoms or Conditions2,264
- Skin Tears59
- Tissue Breakdown59
- Skin Inflammation/ Irritation24
- Distress14
- Erythema10
- Laceration(s)10
- Rash10
Recent adverse event reports
The 25 most recent of 2,348 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951282 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951277 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951276 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951274 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951266 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951263 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951261 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951257 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951255 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951094 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
The distributor reported that the colored dot was found on fifty-nine dressings. The product was not used. The photographs depicting the issue were received from the complainant.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951093 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951092 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951090 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951087 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951081 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951074 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951073 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951071 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
The distributor reported that the colored dot was found on fifty-nine dressings. The product was not used. The photographs depicting the issue were received from the complainant.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951069 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951067 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951062 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
The distributor reported that the colored dot was found on fifty-nine dressings. The product was not used. The photographs depicting the issue were received from the complainant.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951061 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951055 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
The distributor reported that the colored dot was found on fifty-nine dressings. The product was not used. The photographs depicting the issue were received from the complainant.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951054 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951051 ↗
Other Dressing, Wound, Occlusive devices
- DUODERM 187957Convatec, Purchasing Department · Dressing, Wound, Occlusive4,342 reports
- DUODERM 187660Convatec, Purchasing Department · Dressing, Wound, Occlusive207 reports
- DUODERM 187961Convatec, Purchasing Department · Dressing, Wound, Occlusive153 reports
- SAM Chest Seal CS203-ENSAM Medical Products · Dressing, Wound, Occlusive1 recall0 reports
- DUODERM 187662Convatec, Purchasing Department · Dressing, Wound, Occlusive43 reports
- ALLEVYN LIFE L 15.4X15.4 CTN10 66801069Smith & Nephew Medical Limited · Dressing, Wound, Occlusive28 reports
- ALLEVYN LIFE SACRUM (LARGE) PACK OF 10 66801307Smith & Nephew Medical Limited · Dressing, Wound, Occlusive28 reports
- DUODERM 187900Convatec, Purchasing Department · Dressing, Wound, Occlusive25 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.