DUODERM 187660Recalls & reported problems
Convatec, Purchasing Department · DUODERM CGF DRS 10x10CM (1x5PK) NAI · Class 1
Quick summary
This Convatec DuoDERM wound dressing has 206 adverse event reports, with no deaths and no injuries. Most reports describe dressings arriving unsterile, often with unsealed packaging, damaged packs or foreign matter inside. Reports rose to 82 in the last 12 months from 47 in the previous 12. No recalls name this device.
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
- 207
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 207 adverse event reports that list this exact device (DI 00768455106974), received between Mar 28, 2022 and Aug 18, 2026 — classified as 207 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (207 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 Product207
- Contamination /Decontamination Problem177
- Packaging Problem32
- Unsealed Device Packaging27
- Device Damaged Prior to Use18
- Device Contaminated During Manufacture or Shipping3
- Device Damaged Prior to Receipt by User1
Patient problems
- No Clinical Signs, Symptoms or Conditions207
Recent adverse event reports
The 25 most recent of 207 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Receipt by User
To date no additional patient or event details have been received.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50304920 ↗MalfunctionJun 12, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE DISTRIBUTOR REPORTED THAT THE DRESSING PACKAGE WAS NOT SEALED. IT WAS UNKNOWN WHETHER THE PRODUCT WAS USED ON PATIENT OR NOT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25483747 ↗MalfunctionJun 12, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE DISTRIBUTOR REPORTED THAT THE DRESSING PACKAGE WAS NOT SEALED. IT WAS UNKNOWN WHETHER THE PRODUCT WAS USED ON PATIENT OR NOT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25483746 ↗MalfunctionJun 12, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE DISTRIBUTOR REPORTED THAT THE DRESSING PACKAGE WAS NOT SEALED. IT WAS UNKNOWN WHETHER THE PRODUCT WAS USED ON PATIENT OR NOT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25483745 ↗MalfunctionJun 12, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE DISTRIBUTOR REPORTED THAT THE DRESSING PACKAGE WAS NOT SEALED. IT WAS UNKNOWN WHETHER THE PRODUCT WAS USED ON PATIENT OR NOT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25483629 ↗MalfunctionJun 12, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE DISTRIBUTOR REPORTED THAT THE DRESSING PACKAGE WAS NOT SEALED. IT WAS UNKNOWN WHETHER THE PRODUCT WAS USED ON PATIENT OR NOT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25483614 ↗MalfunctionMay 7, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TWENTY FIVE OF DRESSINGS WERE FOUND WITH FOREIGN MATTER INSIDE. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25115624 ↗MalfunctionMay 7, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TWENTY-FIVE OF DRESSINGS WERE FOUND WITH FOREIGN MATTER INSIDE. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25115576 ↗MalfunctionMay 7, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TWENTY FIVE OF DRESSINGS WERE FOUND WITH FOREIGN MATTER INSIDE. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114983 ↗MalfunctionMay 7, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TWENTY FIVE OF DRESSINGS WERE FOUND WITH FOREIGN MATTER INSIDE. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114982 ↗MalfunctionMay 7, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TWENTY-FIVE OF DRESSINGS WERE FOUND WITH FOREIGN MATTER INSIDE. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114977 ↗MalfunctionMay 7, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TWENTY FIVE OF DRESSINGS WERE FOUND WITH FOREIGN MATTER INSIDE. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114976 ↗MalfunctionMay 7, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TWENTY FIVE OF DRESSINGS WERE FOUND WITH FOREIGN MATTER INSIDE. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114975 ↗MalfunctionMay 7, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TWENTY FIVE OF DRESSINGS WERE FOUND WITH FOREIGN MATTER INSIDE. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114968 ↗MalfunctionMay 7, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TWENTY-FIVE OF DRESSINGS WERE FOUND WITH FOREIGN MATTER INSIDE. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114941 ↗MalfunctionMay 7, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TWENTY-FIVE OF DRESSINGS WERE FOUND WITH FOREIGN MATTER INSIDE. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114939 ↗MalfunctionMay 7, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TWENTY-FIVE OF DRESSINGS WERE FOUND WITH FOREIGN MATTER INSIDE. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114934 ↗MalfunctionMay 7, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TWENTY-FIVE OF DRESSINGS WERE FOUND WITH FOREIGN MATTER INSIDE. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114928 ↗MalfunctionMay 7, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TWENTY FIVE OF DRESSINGS WERE FOUND WITH FOREIGN MATTER INSIDE. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114909 ↗MalfunctionMay 7, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TWENTY FIVE OF DRESSINGS WERE FOUND WITH FOREIGN MATTER INSIDE. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114345 ↗MalfunctionMay 7, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TWENTY-FIVE OF DRESSINGS WERE FOUND WITH FOREIGN MATTER INSIDE. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114341 ↗MalfunctionMay 7, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TWENTY-FIVE OF DRESSINGS WERE FOUND WITH FOREIGN MATTER INSIDE. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114339 ↗MalfunctionMay 7, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TWENTY FIVE OF DRESSINGS WERE FOUND WITH FOREIGN MATTER INSIDE. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114337 ↗MalfunctionMay 7, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TWENTY-FIVE OF DRESSINGS WERE FOUND WITH FOREIGN MATTER INSIDE. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114336 ↗MalfunctionMay 7, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TWENTY-FIVE OF DRESSINGS WERE FOUND WITH FOREIGN MATTER INSIDE. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114335 ↗
Other Dressing, Wound, Occlusive devices
- DUODERM 187957Convatec, Purchasing Department · Dressing, Wound, Occlusive4,342 reports
- DUODERM 187955Convatec, Purchasing Department · Dressing, Wound, Occlusive1 recall2,348 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.