DUODERM 187957Recalls & reported problems
Convatec, Purchasing Department · DUODERM XTHIN DRS 15X15CM (1x10PK) NAI · Class 1
Quick summary
This Duoderm Xthin is an occlusive wound dressing. Its 3,062 adverse event reports mostly describe foreign matter inside the packaging, dressings delivered unsterile, and damaged or unsealed packages. The reports include no deaths and no injuries. No recalls name this device. Reports fell to 335 over the last year, from 863 the year before.
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
- 4,342
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4,342 adverse event reports that list this exact device (DI 00768455106929), received between May 2, 2019 and Sep 29, 2026 — classified as 4,342 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (4,256 reports).
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
Most reported problems
Device problems
- Delivered as Unsterile Product4,256
- Contamination /Decontamination Problem4,095
- Packaging Problem220
- Device Damaged Prior to Use213
- Unsealed Device Packaging129
- Tear, Rip or Hole in Device Packaging56
- Nonstandard Device24
- Device Contaminated During Manufacture or Shipping15
Patient problems
- No Clinical Signs, Symptoms or Conditions4,338
- Tissue Breakdown3
- No Patient Involvement1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 25 most recent of 4,342 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931253 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931252 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931230 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931229 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931224 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931221 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931220 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931218 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931214 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931213 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931141 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931138 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
The distributor reported that dark colored particles embedded in the adhesive/hydrocolloid which were greater than 0.1 square millimeter in size. The product was not used on patient. A photograph depicting the issue was received from the complainant.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931136 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931134 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931129 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931128 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931126 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931125 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931123 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931118 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931117 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
The distributor reported that dark colored particles embedded in the adhesive/hydrocolloid which were greater than 0.1 square millimeter in size. The product was not used on patient. A photograph depicting the issue was received from the complainant.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931115 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931111 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
The distributor reported that dark colored particles embedded in the adhesive/hydrocolloid which were greater than 0.1 square millimeter in size. The product was not used on patient. A photograph depicting the issue was received from the complainant.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931105 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931090 ↗
Other Dressing, Wound, Occlusive devices
- DUODERM 187955Convatec, Purchasing Department · Dressing, Wound, Occlusive1 recall2,348 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.