ALLEVYN LIFE M 12.9X12.9 CTN10 66801068Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 05000223478018), received between Oct 14, 2020 and Aug 26, 2021 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (15 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE LITERATURE ARTICLE NAME "EFFECTIVENESS OF USING A NEW POLYURETHANE FOAM MULTI-LAYER DRESSING IN THE SACRAL AREA TO PREVENT THE ONSET OF PRESSURE ULCER IN THE ELDERLY WITH HIP FRACTURES: A PRAGMATIC RANDOMISED CONTROLLED TRIAL", IT WAS REPORTED THAT, WHEN USING ALLEVYN LIFE M 12.9X12.9 CTN10 TO PREVENT THE ONSET OF PRESSURE ULCER IN ELDERLY PATIENTS WITH HIP FRACTURES, 6 PATIENTS SUFFERED A LEVEL 2 PRESSURE ULCER FORMATION. FURTHER INFORMATION ON HOW WAS THE TREATMENT CONCLUDED IS NOT AVAILABLE.

  Patient problems: Ulcer

  MAUDE report 12370179 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE LITERATURE ARTICLE NAME "EFFECTIVENESS OF USING A NEW POLYURETHANE FOAM MULTI-LAYER DRESSING IN THE SACRAL AREA TO PREVENT THE ONSET OF PRESSURE ULCER IN THE ELDERLY WITH HIP FRACTURES: A PRAGMATIC RANDOMISED CONTROLLED TRIAL", IT WAS REPORTED THAT, WHEN USING ALLEVYN LIFE M 12.9X12.9 CTN10 TO PREVENT THE ONSET OF PRESSURE ULCER IN ELDERLY PATIENTS WITH HIP FRACTURES, 2 PATIENTS SUFFERED A LEVEL 1 PRESSURE ULCER FORMATION. FURTHER INFORMATION ON HOW WAS THE TREATMENT CONCLUDED IS NOT AVAILABLE.

  Patient problems: Ulcer

  MAUDE report 12370145 ↗
• MalfunctionMar 7, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT, DURING DRESSING CHANGE, SILICONE IS COMING AWAY FROM THE DRESSING ONTO THE LINER WHILE REMOVING THE LINER FOR APPLICATION AND ALSO SILICONE IS STAYING ON THE SKIN/WOUND WHILE REMOVING THE DRESSING TO REPLACE WITH A NEW DRESSING. IT IS UNKNOWN WHEN DID THE EVENT HAPPENED HOW WAS THE PROCEDURE FINISHED AND IF THERE WAS A DELAY. NO OTHER COMPLICATIONS WHERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11429785 ↗
• MalfunctionJan 6, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE ALLEVYN LIFE WAS APPLIED TO AN OPEN EXUDATIVE WOUND. WHEN IT WAS REMOVED SEVERAL DAYS LATER, IT HAD AN EXUDATE LEAK, IT DID NOT HAVE AN IMAGE ON THE EXUDATE UPTAKE DRESSING CHANGE INDICATOR. THE NURSE SAYS THAT THE SILICONE LAYER WAS "STUCK", AS IF IT HAD CREATED A BARRIER AND THE EXUDATE WAS NOT ABSORBED PROPERLY, SO THE WOUND DID NOT PROGRESS POSITIVELY. TREATMENT WAS CONTINUED WITH A BACK-UP WITH NO DELAY. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11127437 ↗
• MalfunctionDec 23, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, DURING INSPECTION IT WAS NOTICED THAT THE ALLEVYN LIFE 12.9 CM X 12.9 CM FLOWER, THE STICKY PART REMAINED ON THE REMOVABLE BACKING AND THE SILICONE HAD NO STICKINESS LEFT AT ALL ON IT. THE PINK BORDER DOES APPEAR WRINKLED IN SPOTS. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11066446 ↗
• MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, THE SILICON FROM 100 ALLEVYN LIFE M 12.9X12.9 CTN10 DRESSINGS IS RIPPING OFF IN LARGE PORTIONS, CAUSING SHORTER WEAR TIMES, INHIBITING THEM (HCPS) FROM FOLLOWING THE PREVENTION PROTOCOLS, AND CAUSING RE-STICK ISSUES. INCIDENT OCCURRED DURING SET UP/INSPECTION. NO DELAY, PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11008233 ↗
• MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, THE SILICON FROM 100 ALLEVYN LIFE M 12.9X12.9 CTN10 DRESSINGS IS RIPPING OFF IN LARGE PORTIONS, CAUSING SHORTER WEAR TIMES, INHIBITING THEM (HCPS) FROM FOLLOWING THE PREVENTION PROTOCOLS, AND CAUSING RE-STICK ISSUES. INCIDENT OCCURRED DURING SET UP/INSPECTION. NO DELAY, PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11008224 ↗
• MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, THE SILICON FROM 100 ALLEVYN LIFE M 12.9X12.9 CTN10 DRESSINGS IS RIPPING OFF IN LARGE PORTIONS, CAUSING SHORTER WEAR TIMES, INHIBITING THEM (HCPS) FROM FOLLOWING THE PREVENTION PROTOCOLS, AND CAUSING RE-STICK ISSUES. INCIDENT OCCURRED DURING SET UP/INSPECTION. NO DELAY, PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11008188 ↗
• MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, THE SILICON FROM 100 ALLEVYN LIFE M 12.9X12.9 CTN10 DRESSINGS IS RIPPING OFF IN LARGE PORTIONS, CAUSING SHORTER WEAR TIMES, INHIBITING THEM (HCPS) FROM FOLLOWING THE PREVENTION PROTOCOLS, AND CAUSING RE-STICK ISSUES. INCIDENT OCCURRED DURING SET UP/INSPECTION. NO DELAY, PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11008151 ↗
• MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, THE SILICON FROM 100 ALLEVYN LIFE M 12.9X12.9 CTN10 DRESSINGS IS RIPPING OFF IN LARGE PORTIONS, CAUSING SHORTER WEAR TIMES, INHIBITING THEM (HCPS) FROM FOLLOWING THE PREVENTION PROTOCOLS, AND CAUSING RE-STICK ISSUES. INCIDENT OCCURRED DURING SET UP/INSPECTION. NO DELAY, PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11008146 ↗
• MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, THE SILICON FROM 100 ALLEVYN LIFE M 12.9X12.9 CTN10 DRESSINGS IS RIPPING OFF IN LARGE PORTIONS, CAUSING SHORTER WEAR TIMES, INHIBITING THEM (HCPS) FROM FOLLOWING THE PREVENTION PROTOCOLS, AND CAUSING RE-STICK ISSUES. INCIDENT OCCURRED DURING SET UP/INSPECTION. NO DELAY, PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11007960 ↗
• MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, THE SILICON FROM 100 ALLEVYN LIFE M 12.9X12.9 CTN10 DRESSINGS IS RIPPING OFF IN LARGE PORTIONS, CAUSING SHORTER WEAR TIMES, INHIBITING THEM (HCPS) FROM FOLLOWING THE PREVENTION PROTOCOLS, AND CAUSING RE-STICK ISSUES. INCIDENT OCCURRED DURING SET UP/INSPECTION. NO DELAY, PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11007919 ↗
• MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, THE SILICON FROM 100 ALLEVYN LIFE M 12.9X12.9 CTN10 DRESSINGS IS RIPPING OFF IN LARGE PORTIONS, CAUSING SHORTER WEAR TIMES, INHIBITING THEM (HCPS) FROM FOLLOWING THE PREVENTION PROTOCOLS, AND CAUSING RE-STICK ISSUES. INCIDENT OCCURRED DURING SET UP/INSPECTION. NO DELAY, PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11007915 ↗
• MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, THE SILICON FROM 100 ALLEVYN LIFE M 12.9X12.9 CTN10 DRESSINGS IS RIPPING OFF IN LARGE PORTIONS, CAUSING SHORTER WEAR TIMES, INHIBITING THEM (HCPS) FROM FOLLOWING THE PREVENTION PROTOCOLS, AND CAUSING RE-STICK ISSUES. INCIDENT OCCURRED DURING SET UP/INSPECTION. NO DELAY, PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11007914 ↗
• MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, THE SILICON FROM 100 ALLEVYN LIFE M 12.9X12.9 CTN10 DRESSINGS IS RIPPING OFF IN LARGE PORTIONS, CAUSING SHORTER WEAR TIMES, INHIBITING THEM (HCPS) FROM FOLLOWING THE PREVENTION PROTOCOLS, AND CAUSING RE-STICK ISSUES. INCIDENT OCCURRED DURING SET UP/INSPECTION. NO DELAY, PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11007864 ↗
• MalfunctionDec 10, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE SILICON ADHESION IS COMING OFF ONTO THE PLASTIC BACKING. THE PRODUCT HAS NOT BEEN SUBMITTED TO A CUSTOMER OR USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10987594 ↗
• MalfunctionDec 5, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DRESSING HAD SILICONE LEFT BEHIND ON THE BACKING. NO PATIENTS OR ACCOUNTS ARE INVOLVED IN THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10950907 ↗
• MalfunctionDec 3, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SILICON ADHESION IS COMING OFF ONTO THE PLASTIC BACKING. THE PRODUCT HAS NOT BEEN SUBMITTED TO A CUSTOMER OR USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10939160 ↗
• InjuryNov 27, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT SOME ALLEVYN LIFE DRESSINGS HAVE PEELING PROBLEMS. THE SILICONE IS COMING OFF EITHER ONTO THE PATIENT'S SKIN OR ONTO THE PLASTIC PROTECTOR OF THE DRESSING. SILICONE RESIDUE WAS LEFT IN THE PERIWOUND SKIN OF THE PATIENT. THE WOUND WAS CLEANSED AND THE SILICONE REMOVED. ANOTHER DRESSING WAS APPLIED TO CONTINUE TREATMENT WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10915090 ↗
• MalfunctionOct 14, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT FOR SEVERAL ALLEVYN LIFE M 12.9 X 12.9 CTN10, THE DRESSING'S SILICONE IS COMING OFF IN LARGE SECTIONS ONTO THE BACKING AND ONTO THE PATIENTS. BECAUSE OF THIS, THEY ARE UNABLE TO FOLLOW THE PREVENTION PROTOCOL BECAUSE THE DRESSING BARELY LASTS ONE SHIFT. SILICONE IS EVERYWHERE, AND NOT ADHERING WHEN LIFTED FOR ASSESSMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10680401 ↗
• MalfunctionOct 14, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT FOR SEVERAL ALLEVYN LIFE M 12.9 X 12.9 CTN10, THE DRESSING'S SILICONE IS COMING OFF IN LARGE SECTIONS ONTO THE BACKING AND ONTO THE PATIENTS. BECAUSE OF THIS, THEY ARE UNABLE TO FOLLOW THE PREVENTION PROTOCOL BECAUSE THE DRESSING BARELY LASTS ONE SHIFT. SILICONE IS EVERYWHERE, AND NOT ADHERING WHEN LIFTED FOR ASSESSMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10680397 ↗
• MalfunctionOct 14, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT FOR SEVERAL ALLEVYN LIFE M 12.9 X 12.9 CTN10, THE DRESSING'S SILICONE IS COMING OFF IN LARGE SECTIONS ONTO THE BACKING AND ONTO THE PATIENTS. BECAUSE OF THIS, THEY ARE UNABLE TO FOLLOW THE PREVENTION PROTOCOL BECAUSE THE DRESSING BARELY LASTS ONE SHIFT. SILICONE IS EVERYWHERE, AND NOT ADHERING WHEN LIFTED FOR ASSESSMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10680380 ↗