ALLEVYN LIFE XL 21X21 CTN10 66801070Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05000223478070), received between Oct 7, 2020 and Sep 27, 2022 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, THE DRESSING WAS USED TO PREVENT SKIN TROUBLES DURING 13 HOURS BRAIN SURGERY IN PARK BENCH POSITION, WHEN THE PRODUCT WAS REMOVED FROM THE SKIN, IT WAS CONFIRMED THE PATIENT HAD GOTTEN A CONTACT DERMATITIS. THIS ADVERSE EVENT WAS TREATED BY STEROID THERAPY (RINDERON AND PETROLEUM JELLY) BY A DERMATOLOGIST. THE PATIENT IS IN THE HEALING TENDENCY.

  Patient problems: Contact Dermatitis

  MAUDE report 15492224 ↗
• MalfunctionNov 11, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT DURING A SARCOMA RESECTION SURGERY AN ALLEVYN LIFE XL 21X21 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 12800065 ↗
• 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 XL 21CM X 21CM 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 11816120 ↗
• MalfunctionMar 16, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING TREATMENT THE ADHESIVE DOES NOT STICK. THE ADHESIVE REMAINS ON THE PROTECTIVE PAPER. ONE BOX IS DEFECTIVE. THE TREATMENT WAS DELAYED BY ONE DAY, PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACKUP DEVICE AND NO HARM OR INJURY 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 11493011 ↗
• MalfunctionJan 7, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT WHEN CHECKING AND ALLEVYN LIFE WITH THE NEW BACK-COVER, SILICONE DOES NOT OFFSET INTO THE BACK-COVER, BUT THERE WAS A SMALL LIFT IN THE SILICONE ADHESIVE ON THE FOAM PAD. IT WAS NOTICED THAT THE SILICONE COULD BE EASILY ROLLED OFF THE FOAM PAD. NO CASE WAS INVOLVED. THE CUSTOMER IS NOT HAPPY BECAUSE SHE OFTEN HAS A LOT OF WORK TO CLEAN SILICONE RESIDUES OF THE PATIENTS SKIN WHEN AN ALLEVYN BANDAGE IS REMOVED. THE SILICONE IS STILL TOO SOFT OR AT LEAST HAS A PROBLEM WITH OFFSETTING FROM THE FOAM PAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11132055 ↗
• MalfunctionJan 4, 2021Loss of or Failure to Bond; Nonstandard Device; Loss of or Failure to Bond; 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. BOTH DRESSINGS WERE PLACED ON THE L ANTERIOR THIGH, ONE DRESSING AT A TIME WAS TESTED. NO SILICONE RESIDUE LEFT ON THE BACKINGS UPON APPLICATION FOR BOTH DRESSINGS. DRESSING #1 - THE OUTER EDGE LIFTED WITH ACTIVITY BUT RE-ADHERED WELL AND STAYED IN PLACE. A LARGE AMOUNT OF SILICONE RESIDUE LEFT BEHIND ON THE SKIN UPON REMOVAL FOR DRESSING #1 (1 LARGE PATCH MEASURING 7.5 X 9 CM + 5-6 SMALL BEADS/PATCHES). BORDERS CURLED ON THEMSELVES UPON REMOVAL AND WERE DIFFICULT TO PEEL APART FOR DRESSING #1. DRESSING #1 PULLED THE SKIN MODERATELY UPON REMOVAL WITH MILD TO MODERATE AMOUNT OF PAIN/DISCOMFORT. DRESSING #2 - INNER EDGE LIFTED WITH ACTIVITY. BORDER FOLDED UPON ITSELF AND PEELED APART, HOWEVER DID NOT RE-ADHERE TO THE SKIN. A VERY SMALL AMOUNT OF SILICONE RESIDUE LEFT BEHIND ON THE SKIN UPON REMOVAL FOR DRESSING #2 (1 SMALL PATCH + 3-4 SMALL BEADS). BORDERS WERE EASIER TO PEEL APART THAN DRESSING #1. DRESSING #2 PULLED THE SKIN UPON REMOVAL QUITE A BIT MORE THAN DRESSING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11108503 ↗
• MalfunctionDec 31, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT 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. BOTH DRESSINGS WERE PLACED ON THE L ANTERIOR THIGH, ONE DRESSING AT A TIME WAS TESTED. NO SILICONE RESIDUE LEFT ON THE BACKINGS UPON APPLICATION FOR BOTH DRESSINGS. THE OUTER EDGE LIFTED WITH ACTIVITY BUT RE-ADHERED WELL AND STAYED IN PLACE. A LARGE AMOUNT OF SILICONE RESIDUE LEFT BEHIND ON THE SKIN UPON REMOVAL (1 LARGE PATCH MEASURING 7.5 X 9 CM + 5-6 SMALL BEADS/PATCHES). BORDERS CURLED ON THEMSELVES UPON REMOVAL AND WERE DIFFICULT TO PEEL APART FOR DRESSING. DRESSING PULLED THE SKIN MODERATELY UPON REMOVAL WITH MILD TO MODERATE AMOUNT OF PAIN/DISCOMFORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11101283 ↗
• 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 10987524 ↗
• InjuryDec 7, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING TREATMENT, THE DRESSING DID NOT ABSORB WOUND EXUDATE, AS EXPECTED. WHEN CHANGING THE DRESSING, THE WOUND FLUID WAS GATHERING UNDER THE DRESSING. THIS LED TO SOAKING OF THE WOUND EDGE. PATIENT OUTCOME IS UNKNOWN. IT IS UNKNOWN HOW WAS THE WOUND TREATED. NO 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: Impaired Healing

  MAUDE report 10963570 ↗
• InjuryDec 3, 2020Break; Break

  IT WAS REPORTED THAT THE ALLEVYN LIFE DRESSING WAS RIPPED, CAUSING ALLERGIC REACTION TO PATIENT. THE ALLERGIC REACTION WAS RESOLVED WITH COMPETITOR'S PRODUCTS(CREAMS AND DRESSINGS). ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 10942422 ↗
• 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 10939287 ↗
• MalfunctionOct 7, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED FROM A SALES REPRESENTATIVE THAT THE DRESSINGS WERE OPENED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10643693 ↗