Allevyn Life 66021306Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 05000223481421), received between Oct 12, 2020 and Mar 7, 2021 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (13 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.

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.

• 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 11429786 ↗
• 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 11429783 ↗
• 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 11429782 ↗
• MalfunctionMar 7, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT, DURING AND AFTER PROCEDURE, IT WAS DETECTED THAT SILICONE GETS ATTACHED TO THE DRESSING LINER WHILE REMOVING THE LINER FOR APPLICATION. SILICONE WILL STAY ON THE WOUND WHILE REMOVING THE DRESSING FOR CHANGE. THE PROCEDURE WAS COMPLETED WITH A DELAY IN WOUND HEALING OF MORE THAN 30 MINUTES. THE PROCEDURE WAS COMPLETED USING A SMITH & NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11429738 ↗
• MalfunctionJan 11, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ALLEVYN LIFE SACRUM DRESSING WAS SHEDDING SILICONE ONTO THE PATIENT UPON REMOVAL AND IT IS DIFFICULT TO REMOVE FROM THE SKIN. IT WAS ALSO SHEDDING SILICONE AS THE BACKING IS REMOVED BEFORE APPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11148608 ↗
• MalfunctionJan 11, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ALLEVYN LIFE SACRUM DRESSING WAS SHEDDING SILICONE ONTO THE PATIENT UPON REMOVAL AND IT IS DIFFICULT TO REMOVE FROM THE SKIN. IT WAS ALSO SHEDDING SILICONE AS THE BACKING IS REMOVED BEFORE APPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11148564 ↗
• MalfunctionDec 22, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, THE ALLEVYN LIFE SACRUM IS "SHEDDING" SILICONE ONTO THE PATIENT UPON REMOVAL AND IT'S DIFFICULT TO REMOVE FROM THE SKIN. IT'S ALSO SHEDDING AS THE BACKING IS REMOVED BEFORE APPLICATION. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED OR IF THERE WAS ANY DELAY.

  Patient problems: Skin Tears

  MAUDE report 11057262 ↗
• MalfunctionDec 22, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, THE ALLEVYN LIFE SACRUM IS "SHEDDING" SILICONE ONTO THE PATIENT UPON REMOVAL AND IT'S DIFFICULT TO REMOVE FROM THE SKIN. IT'S ALSO SHEDDING AS THE BACKING IS REMOVED BEFORE APPLICATION. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED OR IF THERE WAS ANY DELAY.

  Patient problems: Skin Tears

  MAUDE report 11057255 ↗
• MalfunctionDec 22, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, THE ALLEVYN LIFE SACRUM IS "SHEDDING" SILICONE ONTO THE PATIENT UPON REMOVAL AND IT'S DIFFICULT TO REMOVE FROM THE SKIN. IT'S ALSO SHEDDING AS THE BACKING IS REMOVED BEFORE APPLICATION. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED OR IF THERE WAS ANY DELAY.

  Patient problems: Skin Tears

  MAUDE report 11057203 ↗
• MalfunctionDec 16, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, SILICONE IS RIPPING OFF IN LARGE PORTIONS FROM THE BACK OF ALLEVYN LIFE SACRUM (SMALL) PACK OF 10 DRESSINGS. THE SILICONE IS GETTING ALL OVER THE PATIENTS, CAUSING SHORTER WEAR TIMES, AND INHIBITING THE CLINICIAN FROM PEEKING UNDER PREVENTION DRESSINGS DUE TO THE FACT THAT THE SILICONE IS JUST COMING OFF AND THEN IT IS IMPOSSIBLE FOR THE DRESSING TO RE STICK. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11016649 ↗
• MalfunctionDec 16, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, SILICONE IS RIPPING OFF IN LARGE PORTIONS FROM THE BACK OF ALLEVYN LIFE SACRUM (SMALL) PACK OF 10 DRESSINGS. THE SILICONE IS GETTING ALL OVER THE PATIENTS, CAUSING SHORTER WEAR TIMES, AND INHIBITING THE CLINICIAN FROM PEEKING UNDER PREVENTION DRESSINGS DUE TO THE FACT THAT THE SILICONE IS JUST COMING OFF AND THEN IT IS IMPOSSIBLE FOR THE DRESSING TO RE STICK. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11016646 ↗
• MalfunctionDec 16, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, SILICONE IS RIPPING OFF IN LARGE PORTIONS FROM THE BACK OF ALLEVYN LIFE SACRUM (SMALL) PACK OF 10 DRESSINGS. THE SILICONE IS GETTING ALL OVER THE PATIENTS, CAUSING SHORTER WEAR TIMES, AND INHIBITING THE CLINICIAN FROM PEEKING UNDER PREVENTION DRESSINGS DUE TO THE FACT THAT THE SILICONE IS JUST COMING OFF AND THEN IT IS IMPOSSIBLE FOR THE DRESSING TO RE STICK. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11016643 ↗
• MalfunctionDec 16, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, SILICONE IS RIPPING OFF IN LARGE PORTIONS FROM THE BACK OF ALLEVYN LIFE SACRUM (SMALL) PACK OF 10 DRESSINGS. THE SILICONE IS GETTING ALL OVER THE PATIENTS, CAUSING SHORTER WEAR TIMES, AND INHIBITING THE CLINICIAN FROM PEEKING UNDER PREVENTION DRESSINGS DUE TO THE FACT THAT THE SILICONE IS JUST COMING OFF AND THEN IT IS IMPOSSIBLE FOR THE DRESSING TO RE STICK. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11016638 ↗
• MalfunctionDec 16, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, SILICONE IS RIPPING OFF IN LARGE PORTIONS FROM THE BACK OF ALLEVYN LIFE SACRUM (SMALL) PACK OF 10 DRESSINGS. THE SILICONE IS GETTING ALL OVER THE PATIENTS, CAUSING SHORTER WEAR TIMES, AND INHIBITING THE CLINICIAN FROM PEEKING UNDER PREVENTION DRESSINGS DUE TO THE FACT THAT THE SILICONE IS JUST COMING OFF AND THEN IT IS IMPOSSIBLE FOR THE DRESSING TO RE STICK. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11016529 ↗
• MalfunctionDec 16, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, SILICONE IS RIPPING OFF IN LARGE PORTIONS FROM THE BACK OF ALLEVYN LIFE SACRUM (SMALL) PACK OF 10 DRESSINGS. THE SILICONE IS GETTING ALL OVER THE PATIENTS, CAUSING SHORTER WEAR TIMES, AND INHIBITING THE CLINICIAN FROM PEEKING UNDER PREVENTION DRESSINGS DUE TO THE FACT THAT THE SILICONE IS JUST COMING OFF AND THEN IT IS IMPOSSIBLE FOR THE DRESSING TO RE STICK. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11016515 ↗
• MalfunctionDec 16, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, SILICONE IS RIPPING OFF IN LARGE PORTIONS FROM THE BACK OF ALLEVYN LIFE SACRUM (SMALL) PACK OF 10 DRESSINGS. THE SILICONE IS GETTING ALL OVER THE PATIENTS, CAUSING SHORTER WEAR TIMES, AND INHIBITING THE CLINICIAN FROM PEEKING UNDER PREVENTION DRESSINGS DUE TO THE FACT THAT THE SILICONE IS JUST COMING OFF AND THEN IT IS IMPOSSIBLE FOR THE DRESSING TO RE STICK. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11016510 ↗
• MalfunctionDec 16, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, SILICONE IS RIPPING OFF IN LARGE PORTIONS FROM THE BACK OF ALLEVYN LIFE SACRUM (SMALL) PACK OF 10 DRESSINGS. THE SILICONE IS GETTING ALL OVER THE PATIENTS, CAUSING SHORTER WEAR TIMES, AND INHIBITING THE CLINICIAN FROM PEEKING UNDER PREVENTION DRESSINGS DUE TO THE FACT THAT THE SILICONE IS JUST COMING OFF AND THEN IT IS IMPOSSIBLE FOR THE DRESSING TO RE STICK. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11016497 ↗
• MalfunctionDec 16, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, SILICONE IS RIPPING OFF IN LARGE PORTIONS FROM THE BACK OF ALLEVYN LIFE SACRUM (SMALL) PACK OF 10 DRESSINGS. THE SILICONE IS GETTING ALL OVER THE PATIENTS, CAUSING SHORTER WEAR TIMES, AND INHIBITING THE CLINICIAN FROM PEEKING UNDER PREVENTION DRESSINGS DUE TO THE FACT THAT THE SILICONE IS JUST COMING OFF AND THEN IT IS IMPOSSIBLE FOR THE DRESSING TO RE STICK. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11016486 ↗
• MalfunctionDec 16, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, SILICONE IS RIPPING OFF IN LARGE PORTIONS FROM THE BACK OF ALLEVYN LIFE SACRUM (SMALL) PACK OF 10 DRESSINGS. THE SILICONE IS GETTING ALL OVER THE PATIENTS, CAUSING SHORTER WEAR TIMES, AND INHIBITING THE CLINICIAN FROM PEEKING UNDER PREVENTION DRESSINGS DUE TO THE FACT THAT THE SILICONE IS JUST COMING OFF AND THEN IT IS IMPOSSIBLE FOR THE DRESSING TO RE STICK. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11016450 ↗
• 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 10987542 ↗
• MalfunctionDec 3, 2020Loss of or Failure to Bond; Material Integrity Problem; Loss of or Failure to Bond; 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 10937387 ↗
• MalfunctionOct 12, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE DRESSINGS WERE OPENED BY THE SALES REPRESENTATIVE AND GLUED TO A HOLDER FOR A DEMONSTRATION PRESENTATION. SOME DRESSINGS DO NOT EVEN STICK TO THE HOLDER BECAUSE THE SILICONE REMAINS ON THE REMOVABLE PLASTIC PART OF THE DEVICE. NO PATIENT WAS INVOLVED IN THIS EVENT. 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; No Consequences Or Impact To Patient

  MAUDE report 10667624 ↗