ALLEVYN LIFE L 15.4X15.4 CTN10 66801069Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 05000223478049), received between Nov 10, 2020 and Nov 30, 2021 — classified as 4 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (19 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY (ACL OR OTHER), UPON REMOVAL OF THE ALLEVYN LIFE L 15.4X15.4 CTN10, IT WAS OBSERVED THAT THE PATIENT'S SKIN WAS MACERATED. ALSO, ACCORDING TO CLIENT´S DESCRIPTION THERE WAS A LOT OF ADHESIVE RESIDUE. TREATMENT WAS RESUMED, WITH A GREATER 30 MINUTES DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Skin Disorders

  MAUDE report 12894272 ↗
• InjuryNov 12, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT DURING A SARCOMA RESECTION SURGERY AN ALLEVYN LIFE L 15.4X15.4 CTN10 WAS USED ON THE PATIENT, THE SILICONE PLATES WAS PLACED IN THE BONY PROMINENCES ACCORDANTLY TO THE INSTITUTIONAL PROTOCOL PATIENT WAS IN VENTRAL POSITION WAS REQUIRED DURING PROCEDURE, SURGERY LASTED FOR 1 HOUR AND 30 MINUTES AND WHEN RETURNING PATIENT TO DDH POSITION AND AFTER REMOVING THE PLATES IT WAS NOTICED THAT THE PATIENT'S SKIN HAD MACERATIONS AND LOOKED LIKE A KIND OF "GLUE". THIS PROBLEM WAS TREATED USING 5 SACHETS OF STING FREE ADHESIVE REMOVER.

  Patient problems: Skin Disorders

  MAUDE report 12804752 ↗
• MalfunctionMay 13, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT AFTER AN UNKNOWN NUMBER OF ALLEVYN LIFE 15.4 CM X 15.4CM CTN 10S WERE REMOVED FROM THE SKIN, A RESIDUE OF SILICONE ADHESIVE WAS LEFT ON THE SKIN OF THE PATIENTS. PATIENTS WERE NOT HARMED. FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816123 ↗
• MalfunctionMay 10, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, BEFORE TREATMENT WITH ALLEVYN LIFE L 15.4X15.4 CTN10, WHEN THREE (3) CARRIER WERE REMOVED FROM THE SAME BOX, PART OF THE SILICONE ADHESIVE WAS REMOVED WITH THE CARRIER AND DID NOT REMAIN ON THE HALF PART OF THE DRESSING, SO IT COULD NOT BE USED. THE TREATMENT WAS SUCCESSFULLY COMPLETED USING A BACK UP DRESSING. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11802804 ↗
• MalfunctionMar 23, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT RECEIVED SOME ALLEVYN DRESSINGS, THE FIRST ONE WAS NOT USED DUE TO DECREASED ADHESIVE A SECOND ONE WAS USED AS ONLY A SMALL NICKEL SIZE AREA WAS MISSING. THE REST WERE NOT OPEN BUT THE CUSTOMER ASSUMES SINCE FIRST 2 WERE DEFECTIVE, THE REST MAY BE AS WELL. PATIENT ALSO HAD TO USE SOME OF HIS PERSONAL BACK STOCK HE PURCHASED INDEPENDENTLY SINCE THEY ARE NOT STICKING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11553617 ↗
• MalfunctionMar 16, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN OPENING THE SINGLE PRODUCT PACKAGE, DROPS OF SILICONE LOOSE FROM THE DRESSING WERE NOTICED IN THE WRAPPER. THERE WAS A SUBSEQUENT DIFFICULTY IN ADHESION REQUIRING REINFORCEMENT. EVEN SO, THE DURATION OF THE DRESSING AT THE SITE DECREASED. THE DRESSING ONLY LASTED 1 DAY. TREATMENT WAS COMPLETED WITH A BACK-UP WITH NO DELAY. 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 11492295 ↗
• InjuryMar 14, 2021Loss of or Failure to Bond; Defective Device; Loss of or Failure to Bond; Defective Device

  IT WAS REPORTED THAT, DURING TREATMENT, CUSTOMER STATED THAT ALLEVYN DEVICE FORM OF ABSORPTION DOES NOT OCCUR IN A VERTICAL WAY, BUT IN A TRANSVERSAL WAY, MACERATING THE MARGINS. THERE IS ALSO THE DISPLACEMENT OF THE COVERING ON THE SKIN CAUSING THE EDGES TO CURL, IMPLYING FREQUENT CHANGES OF THE COVERING. ALSO, COMPLAINED THAT THE PACKAGING / SEAL FOR BEING TRANSPARENT IS DIFFICULT TO RELEASE THE FOAM, COMPROMISING THE APPLICATION OF THE PRODUCT AND THE ASEPTIC TECHNIQUE. THE TREATMENT WAS COMPLETED WITHOUT DELAY USING A SMITH & NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Skin Infection

  MAUDE report 11478989 ↗
• 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 11429784 ↗
• 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 11429736 ↗
• MalfunctionJan 28, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING TREATMENT THE SILICONE CONTACT LAYER SEEMS TO BE STICKING TO THE BACKING OF THE DRESSING WHEN TAKEN OFF TO APPLY. THEN THE PRODUCT IS NOT STAYING IN PLACE AS IT SHOULD, AND AS IT HAS DONE IN THE PAST. IT IS FALLING OFF BETWEEN NURSE VISITS. PATIENT STATED THAT HE HAS BEEN ABLE TO ¿SLIDE FINGER INTO DRESSING BORDER WHERE THE DRESSING ISN'T STAYING ADHERED TO SKIN¿ WHICH IS UNUSUAL FOR THE DRESSING AS PREVIOUSLY NO ISSUES. NO PATIENT HARM 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 11243369 ↗
• MalfunctionJan 22, 2021Loss of or Failure to Bond; Material Integrity Problem; Loss of or Failure to Bond; Material Integrity Problem

  IT WAS REPORTED THAT THE WOUND CARE TEAM AT (B)(6) HAS EXPERIENCED THAT THE SILICONE WAS BEADING AND STICKING TO PATIENTS SKIN AND ALSO THE BACK OF THE TABS UPON REMOVAL FROM THE DRESSING. THEY HAVE NOTED THAT THE SILICONE IS STICKIER THAN IT PREVIOUSLY WAS AND HAS POTENTIAL TO CAUSE HARM TO PATIENTS UPON REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11214396 ↗
• MalfunctionDec 31, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT TWO DRESSINGS FROM TWO DIFFERENT BOXES WERE TESTED BY S+N REP PRIOR TO SENDING TO A CUSTOMER FOR EVALUATION TO ENSURE PRODUCT WAS SAFE FOR PATIENT USE. THIS EVENT DID NOT INVOLVE A PATIENT OR HCP. DRESSINGS WERE PLACED ON THE ANTERIOR THIGH AND ANTERIOR SHIN. LARGE PATCHES OF SILICONE RESIDUE LEFT ON THE BACKINGS UPON APPLICATION WITH SMALL AMOUNT OF SILICONE RESIDUE LEFT BEHIND ON THE SKIN UPON REMOVAL FOR BOTH DRESSINGS. BORDERS CURLED ON THEMSELVES UPON REMOVAL AND WOULD NOT PEEL APART. ALSO PULLED THE SKIN A LITTLE UPON REMOVAL (R ANTERIOR THIGH ONLY), NO PAIN OR DISCOMFORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11101269 ↗
• MalfunctionDec 31, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED A DRESSING WAS TESTED BY S+N REP PRIOR TO SENDING TO A CUSTOMER FOR EVALUATION TO ENSURE PRODUCT WAS SAFE FOR PATIENT USE. THIS EVENT DID NOT INVOLVE A PATIENT OR HCP. DRESSINGS WAS PLACED ON THE ANTERIOR SHIN. LARGE PATCHES OF SILICONE RESIDUE LEFT ON THE BACKINGS UPON APPLICATION WITH SMALL AMOUNT OF SILICONE RESIDUE LEFT BEHIND ON THE SKIN UPON REMOVAL FOR BOTH DRESSINGS. BORDERS CURLED ON THEMSELVES UPON REMOVAL AND WOULD NOT PEEL APART. NO PAIN OR DISCOMFORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11101100 ↗
• MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, THE SILICONE IS RIPPING OFF IN LARGE PORTIONS FROM THE BACK OF ALLEVYN LIFE 15.4 CM X 15.4CM CTN 10 DRESSINGS (100 DRESSINGS WERE REPORTED). THIS ISSUE IS CAUSING SHORTER WEAR TIMES, INHIBITING THE CLINICIAN FROM PEEKING UNDER PREVENTION DRESSINGS AND CAUSING PROBLEMS TO RE STICK THE DRESSINGS. 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 11013440 ↗
• MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, THE SILICONE IS RIPPING OFF IN LARGE PORTIONS FROM THE BACK OF ALLEVYN LIFE 15.4 CM X 15.4CM CTN 10 DRESSINGS (100 DRESSINGS WERE REPORTED). THIS ISSUE IS CAUSING SHORTER WEAR TIMES, INHIBITING THE CLINICIAN FROM PEEKING UNDER PREVENTION DRESSINGS AND CAUSING PROBLEMS TO RE STICK THE DRESSINGS. 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 11013382 ↗
• MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, THE SILICONE IS RIPPING OFF IN LARGE PORTIONS FROM THE BACK OF ALLEVYN LIFE 15.4 CM X 15.4CM CTN 10 DRESSINGS (100 DRESSINGS WERE REPORTED). THIS ISSUE IS CAUSING SHORTER WEAR TIMES, INHIBITING THE CLINICIAN FROM PEEKING UNDER PREVENTION DRESSINGS AND CAUSING PROBLEMS TO RE STICK THE DRESSINGS. 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 11013367 ↗
• MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, THE SILICONE IS RIPPING OFF IN LARGE PORTIONS FROM THE BACK OF ALLEVYN LIFE 15.4 CM X 15.4CM CTN 10 DRESSINGS (100 DRESSINGS WERE REPORTED). THIS ISSUE IS CAUSING SHORTER WEAR TIMES, INHIBITING THE CLINICIAN FROM PEEKING UNDER PREVENTION DRESSINGS AND CAUSING PROBLEMS TO RE STICK THE DRESSINGS. 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 11013306 ↗
• MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, THE SILICONE IS RIPPING OFF IN LARGE PORTIONS FROM THE BACK OF ALLEVYN LIFE 15.4 CM X 15.4CM CTN 10 DRESSINGS (100 DRESSINGS WERE REPORTED). THIS ISSUE IS CAUSING SHORTER WEAR TIMES, INHIBITING THE CLINICIAN FROM PEEKING UNDER PREVENTION DRESSINGS AND CAUSING PROBLEMS TO RE STICK THE DRESSINGS. 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 11013289 ↗
• MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, THE SILICONE IS RIPPING OFF IN LARGE PORTIONS FROM THE BACK OF ALLEVYN LIFE 15.4 CM X 15.4CM CTN 10 DRESSINGS (100 DRESSINGS WERE REPORTED). THIS ISSUE IS CAUSING SHORTER WEAR TIMES, INHIBITING THE CLINICIAN FROM PEEKING UNDER PREVENTION DRESSINGS AND CAUSING PROBLEMS TO RE STICK THE DRESSINGS. 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 11008608 ↗
• MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, THE SILICONE IS RIPPING OFF IN LARGE PORTIONS FROM THE BACK OF ALLEVYN LIFE 15.4 CM X 15.4CM CTN 10 DRESSINGS (100 DRESSINGS WERE REPORTED). THIS ISSUE IS CAUSING SHORTER WEAR TIMES, INHIBITING THE CLINICIAN FROM PEEKING UNDER PREVENTION DRESSINGS AND CAUSING PROBLEMS TO RE STICK THE DRESSINGS. 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 11008592 ↗
• MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, THE SILICONE IS RIPPING OFF IN LARGE PORTIONS FROM THE BACK OF ALLEVYN LIFE 15.4 CM X 15.4CM CTN 10 DRESSINGS (100 DRESSINGS WERE REPORTED). THIS ISSUE IS CAUSING SHORTER WEAR TIMES, INHIBITING THE CLINICIAN FROM PEEKING UNDER PREVENTION DRESSINGS AND CAUSING PROBLEMS TO RE STICK THE DRESSINGS. 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 11008579 ↗
• MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, THE SILICONE IS RIPPING OFF IN LARGE PORTIONS FROM THE BACK OF ALLEVYN LIFE 15.4 CM X 15.4CM CTN 10 DRESSINGS (100 DRESSINGS WERE REPORTED). THIS ISSUE IS CAUSING SHORTER WEAR TIMES, INHIBITING THE CLINICIAN FROM PEEKING UNDER PREVENTION DRESSINGS AND CAUSING PROBLEMS TO RE STICK THE DRESSINGS. 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 11008551 ↗
• MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, THE SILICONE IS RIPPING OFF IN LARGE PORTIONS FROM THE BACK OF ALLEVYN LIFE 15.4 CM X 15.4CM CTN 10 DRESSINGS (100 DRESSINGS WERE REPORTED). THIS ISSUE IS CAUSING SHORTER WEAR TIMES, INHIBITING THE CLINICIAN FROM PEEKING UNDER PREVENTION DRESSINGS AND CAUSING PROBLEMS TO RE STICK THE DRESSINGS. 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 11008541 ↗
• 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 10987519 ↗
• 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 10939210 ↗