DUODERM 187961Recalls & reported problems
Convatec, Purchasing Department · DuoDERM® CGF® Extra Thin Dressing - 2" X 8" (Rectangle) · Class 1
Quick summary
This DuoDERM CGF Extra Thin dressing is a wound dressing that covers and protects skin wounds. Its 153 reports mostly describe dressings arriving unsterile or contaminated, with some unsealed packaging and dressings that did not absorb fluid. The reports include no deaths and no injuries. No recalls name this device. Reports dropped from 68 in the year before to 1 in the latest 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
- 153
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 00768455102822), received between Apr 28, 2021 and Jan 22, 2026 — classified as 153 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (151 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 Product151
- Contamination /Decontamination Problem128
- Packaging Problem19
- Unsealed Device Packaging8
- Device Damaged Prior to Use3
- Nonstandard Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions153
Recent adverse event reports
The 25 most recent of 153 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 2026Nonstandard Device
IT WAS REPORTED BY DISTRIBUTOR THAT THE DRESSING DID NOT ABSORB THE EXUDATE. THE CUSTOMER PROVIDED A PHOTOGRAPH AS EVIDENCE OF THE ISSUE AND REPORTED THAT HALF OF THE ITEM HAD BEEN USED .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24144104 ↗MalfunctionAug 29, 2025Nonstandard Device; Nonstandard Device
THE RETAILER NOTIFIED ABOUT THE DRESSING UNABLE TO ABSORB EXUDATE. VIDEO DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22920472 ↗MalfunctionAug 21, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT IN AN INBOUND INSPECTION THERE WERE BLACK SPOTS INSIDE THE DRESSINGS. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22859559 ↗MalfunctionAug 21, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT IN AN INBOUND INSPECTION THERE WERE BLACK SPOTS INSIDE THE DRESSINGS. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22859556 ↗MalfunctionAug 21, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT IN AN INBOUND INSPECTION THERE WERE BLACK SPOTS INSIDE THE DRESSINGS. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22859534 ↗MalfunctionAug 21, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT IN AN INBOUND INSPECTION THERE WERE BLACK SPOTS INSIDE THE DRESSINGS. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22858952 ↗MalfunctionAug 21, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT IN AN INBOUND INSPECTION THERE WERE BLACK SPOTS INSIDE THE DRESSINGS. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22858942 ↗MalfunctionAug 21, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT IN AN INBOUND INSPECTION THERE WERE BLACK SPOTS INSIDE THE DRESSINGS. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22858940 ↗MalfunctionAug 21, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT IN AN INBOUND INSPECTION THERE WERE BLACK SPOTS INSIDE THE DRESSINGS. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22858939 ↗MalfunctionAug 21, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT IN AN INBOUND INSPECTION THERE WERE BLACK SPOTS INSIDE THE DRESSINGS. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22858938 ↗MalfunctionAug 21, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT IN AN INBOUND INSPECTION THERE WERE BLACK SPOTS INSIDE THE DRESSINGS. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22858934 ↗MalfunctionAug 21, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT IN AN INBOUND INSPECTION THERE WERE BLACK SPOTS INSIDE THE DRESSINGS. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22858929 ↗MalfunctionAug 21, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT IN AN INBOUND INSPECTION THERE WERE BLACK SPOTS INSIDE THE DRESSINGS. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22858859 ↗MalfunctionAug 21, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT IN AN INBOUND INSPECTION THERE WERE BLACK SPOTS INSIDE THE DRESSINGS. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22858857 ↗MalfunctionAug 21, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT IN AN INBOUND INSPECTION THERE WERE BLACK SPOTS INSIDE THE DRESSINGS. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22858856 ↗MalfunctionAug 21, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT IN AN INBOUND INSPECTION THERE WERE BLACK SPOTS INSIDE THE DRESSINGS. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22858855 ↗MalfunctionAug 21, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT IN AN INBOUND INSPECTION THERE WERE BLACK SPOTS INSIDE THE DRESSINGS. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22858849 ↗MalfunctionAug 21, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT IN AN INBOUND INSPECTION THERE WERE BLACK SPOTS INSIDE THE DRESSINGS. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22858846 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TEN PIECES OF DRESSING WITH COLORED DOT. THE PRODUCT WAS NOT USED ON PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22294609 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TEN PIECES OF DRESSING WITH COLORED DOT. THE PRODUCT WAS NOT USED ON PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22294608 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TEN PIECES OF DRESSING WITH COLORED DOT. THE PRODUCT WAS NOT USED ON PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22294607 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TEN PIECES OF DRESSING WITH COLORED DOT. THE PRODUCT WAS NOT USED ON PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22294606 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TEN PIECES OF DRESSING WITH COLORED DOT. THE PRODUCT WAS NOT USED ON PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22294605 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TEN PIECES OF DRESSING WITH COLORED DOT. THE PRODUCT WAS NOT USED ON PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22294604 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT TEN PIECES OF DRESSING WITH COLORED DOT. THE PRODUCT WAS NOT USED ON PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22294603 ↗
Other Dressing, Wound, Occlusive devices
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- DUODERM 187955Convatec, Purchasing Department · Dressing, Wound, Occlusive1 recall2,348 reports
- DUODERM 187660Convatec, Purchasing Department · Dressing, Wound, Occlusive207 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.