DUODERM 187900Recalls & reported problems
Convatec, Purchasing Department · DUODERM XTHIN DRS 5X10CM (1x20PK) NAI · Class 1
Quick summary
This ConvaTec DuoDERM wound dressing is the subject of 25 adverse event reports, mostly describing dressings arriving outside their packaging, unsealed or unsterile, or damaged before use; some reports describe skin tearing during removal. There were no deaths or reported injuries. No recalls name this device. Reports rose to 22 in the recent year from 0 in the prior year.
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
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00768455102778), received between May 10, 2024 and Aug 27, 2026 — classified as 25 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (23 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 Product23
- Device Damaged Prior to Use20
- Unsealed Device Packaging20
- Contamination /Decontamination Problem3
- Difficult to Remove2
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- Skin Tears2
- Tissue Breakdown2
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Difficult to Remove
The customer reported that the dressing caused skin damage during removal. She stated that after a short period of wear, the dressing adhered firmly to the skin and, upon removal, resulted in skin tearing. The client discontinued use of the product following the event. Product use and appropriate removal techniques were discussed with the client. No concomitant medications were reported. Outcome was reported as skin torn/ripped. No photo is available at this time.
Patient problems: Skin Tears; Tissue Breakdown
MAUDE report 50470490 ↗MalfunctionAug 27, 2026Difficult to Remove
The customer reported that the dressing caused skin damage during removal. She stated that after a short period of wear, the dressing adhered firmly to the skin and, upon removal, resulted in skin tearing. The client discontinued use of the product following the event. Product use and appropriate removal techniques were discussed with the client. No concomitant medications were reported. Outcome was reported as skin torn/ripped. No photo is available at this time.
Patient problems: Skin Tears; Tissue Breakdown
MAUDE report 50470461 ↗MalfunctionMar 10, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE END USER REPORTED THAT NO BOX WAS RECEIVED, JUST THE DRESSINGS OUTSIDE OF THE BOX AND SOME OF THE BLISTER PACKS WERE OPENED. HE USED SOME OF THE PRODUCT ANYWAY, BUT IT ADHERED FOR ONLY ONE DAY. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557801 ↗MalfunctionMar 10, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE END USER REPORTED THAT NO BOX WAS RECEIVED, JUST THE DRESSINGS OUTSIDE OF THE BOX AND SOME OF THE BLISTER PACKS WERE OPENED. HE USED SOME OF THE PRODUCT ANYWAY, BUT IT ADHERED FOR ONLY ONE DAY. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557798 ↗MalfunctionMar 10, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE END USER REPORTED THAT NO BOX WAS RECEIVED, JUST THE DRESSINGS OUTSIDE OF THE BOX AND SOME OF THE BLISTER PACKS WERE OPENED. HE USED SOME OF THE PRODUCT ANYWAY, BUT IT ADHERED FOR ONLY ONE DAY. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557795 ↗MalfunctionMar 10, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE END USER REPORTED THAT NO BOX WAS RECEIVED, JUST THE DRESSINGS OUTSIDE OF THE BOX AND SOME OF THE BLISTER PACKS WERE OPENED. HE USED SOME OF THE PRODUCT ANYWAY, BUT IT ADHERED FOR ONLY ONE DAY. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557794 ↗MalfunctionMar 10, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE END USER REPORTED THAT NO BOX WAS RECEIVED, JUST THE DRESSINGS OUTSIDE OF THE BOX AND SOME OF THE BLISTER PACKS WERE OPENED. HE USED SOME OF THE PRODUCT ANYWAY, BUT IT ADHERED FOR ONLY ONE DAY. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557790 ↗MalfunctionMar 10, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE END USER REPORTED THAT NO BOX WAS RECEIVED, JUST THE DRESSINGS OUTSIDE OF THE BOX AND SOME OF THE BLISTER PACKS WERE OPENED. HE USED SOME OF THE PRODUCT ANYWAY, BUT IT ADHERED FOR ONLY ONE DAY. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557789 ↗MalfunctionMar 10, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE END USER REPORTED THAT NO BOX WAS RECEIVED, JUST THE DRESSINGS OUTSIDE OF THE BOX AND SOME OF THE BLISTER PACKS WERE OPENED. HE USED SOME OF THE PRODUCT ANYWAY, BUT IT ADHERED FOR ONLY ONE DAY. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557788 ↗MalfunctionMar 10, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE END USER REPORTED THAT NO BOX WAS RECEIVED, JUST THE DRESSINGS OUTSIDE OF THE BOX AND SOME OF THE BLISTER PACKS WERE OPENED. HE USED SOME OF THE PRODUCT ANYWAY, BUT IT ADHERED FOR ONLY ONE DAY. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557787 ↗MalfunctionMar 10, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE END USER REPORTED THAT NO BOX WAS RECEIVED, JUST THE DRESSINGS OUTSIDE OF THE BOX AND SOME OF THE BLISTER PACKS WERE OPENED. HE USED SOME OF THE PRODUCT ANYWAY, BUT IT ADHERED FOR ONLY ONE DAY. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557786 ↗MalfunctionMar 10, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE END USER REPORTED THAT NO BOX WAS RECEIVED, JUST THE DRESSINGS OUTSIDE OF THE BOX AND SOME OF THE BLISTER PACKS WERE OPENED. HE USED SOME OF THE PRODUCT ANYWAY, BUT IT ADHERED FOR ONLY ONE DAY. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557785 ↗MalfunctionMar 10, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE END USER REPORTED THAT NO BOX WAS RECEIVED, JUST THE DRESSINGS OUTSIDE OF THE BOX AND SOME OF THE BLISTER PACKS WERE OPENED. HE USED SOME OF THE PRODUCT ANYWAY, BUT IT ADHERED FOR ONLY ONE DAY. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557783 ↗MalfunctionMar 10, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE END USER REPORTED THAT NO BOX WAS RECEIVED, JUST THE DRESSINGS OUTSIDE OF THE BOX AND SOME OF THE BLISTER PACKS WERE OPENED. HE USED SOME OF THE PRODUCT ANYWAY, BUT IT ADHERED FOR ONLY ONE DAY. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557782 ↗MalfunctionMar 10, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE END USER REPORTED THAT NO BOX WAS RECEIVED, JUST THE DRESSINGS OUTSIDE OF THE BOX AND SOME OF THE BLISTER PACKS WERE OPENED. HE USED SOME OF THE PRODUCT ANYWAY, BUT IT ADHERED FOR ONLY ONE DAY. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557781 ↗MalfunctionMar 10, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE END USER REPORTED THAT NO BOX WAS RECEIVED, JUST THE DRESSINGS OUTSIDE OF THE BOX AND SOME OF THE BLISTER PACKS WERE OPENED. HE USED SOME OF THE PRODUCT ANYWAY, BUT IT ADHERED FOR ONLY ONE DAY. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557673 ↗MalfunctionMar 10, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE END USER REPORTED THAT NO BOX WAS RECEIVED, JUST THE DRESSINGS OUTSIDE OF THE BOX AND SOME OF THE BLISTER PACKS WERE OPENED. HE USED SOME OF THE PRODUCT ANYWAY, BUT IT ADHERED FOR ONLY ONE DAY. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557672 ↗MalfunctionMar 10, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE END USER REPORTED THAT NO BOX WAS RECEIVED, JUST THE DRESSINGS OUTSIDE OF THE BOX AND SOME OF THE BLISTER PACKS WERE OPENED. HE USED SOME OF THE PRODUCT ANYWAY, BUT IT ADHERED FOR ONLY ONE DAY. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557670 ↗MalfunctionMar 10, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE END USER REPORTED THAT NO BOX WAS RECEIVED, JUST THE DRESSINGS OUTSIDE OF THE BOX AND SOME OF THE BLISTER PACKS WERE OPENED. HE USED SOME OF THE PRODUCT ANYWAY, BUT IT ADHERED FOR ONLY ONE DAY. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557669 ↗MalfunctionMar 10, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE END USER REPORTED THAT NO BOX WAS RECEIVED, JUST THE DRESSINGS OUTSIDE OF THE BOX AND SOME OF THE BLISTER PACKS WERE OPENED. HE USED SOME OF THE PRODUCT ANYWAY, BUT IT ADHERED FOR ONLY ONE DAY. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557668 ↗MalfunctionMar 10, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE END USER REPORTED THAT NO BOX WAS RECEIVED, JUST THE DRESSINGS OUTSIDE OF THE BOX AND SOME OF THE BLISTER PACKS WERE OPENED. HE USED SOME OF THE PRODUCT ANYWAY, BUT IT ADHERED FOR ONLY ONE DAY. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557667 ↗MalfunctionMar 10, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE END USER REPORTED THAT NO BOX WAS RECEIVED, JUST THE DRESSINGS OUTSIDE OF THE BOX AND SOME OF THE BLISTER PACKS WERE OPENED. HE USED SOME OF THE PRODUCT ANYWAY, BUT IT ADHERED FOR ONLY ONE DAY. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557666 ↗MalfunctionMay 10, 2024Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19286250 ↗MalfunctionMay 10, 2024Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19286177 ↗MalfunctionMay 10, 2024Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19286150 ↗
Other Dressing, Wound, Occlusive devices
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- DUODERM 187961Convatec, Purchasing Department · Dressing, Wound, Occlusive153 reports
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- DUODERM 187662Convatec, Purchasing Department · Dressing, Wound, Occlusive43 reports
- ALLEVYN LIFE L 15.4X15.4 CTN10 66801069Smith & Nephew Medical Limited · Dressing, Wound, Occlusive28 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.