ALLEVYN LIFE SACRUM (LARGE) PACK OF 10 66801307Recalls & reported problems
Smith & Nephew Medical Limited · Soft Silicone Hydrocellular Sacrum Dressing with Lock Away Layer · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Smith & Nephew Allevyn Life Sacrum dressing is a soft silicone foam dressing for wounds on the sacrum (lower back, tailbone area). The 28 reports mostly describe the silicone layer detaching or staying behind on the skin when the dressing is removed, so the dressing no longer sticks and removal can pull at skin. Two reports involved injuries and no deaths were reported. No recalls name this device.
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
- 28
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 05000223481452), received between Oct 12, 2020 and Oct 29, 2024 — classified as 2 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (22 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.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond22
- Difficult to Remove4
- Material Integrity Problem3
- Nonstandard Device2
- Adverse Event Without Identified Device or Use Problem1
- Biocompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Consequences Or Impact To Patient4
- Erythema1
- Fungal Infection1
- Hypersensitivity/Allergic reaction1
- Itching Sensation1
- Localized Skin Lesion1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjuryOct 29, 2024Biocompatibility; Biocompatibility
IT WAS REPORTED THAT, DURING WOUND CARE TREATMENT, THE NURSE INFORMED THAT THE PATIENT DEVELOPED A "YEASTY" WOUND BENEATH ONE (1) ALLEVYN LIFE SACRUM (LARGE). DENIES USAGE OF ANY ADDITIONAL PRODUCTS BENEATH THE ALLEVYN DRESSING. SKIN HAD ALSO A BREAKDOWN. THE YEASTY WOUND WAS MANAGED WITH NYSTATIN TOPICAL CREAM TWICE A DAY AND LEFT OPEN TO AIR. PATIENT DID NOT EXPERIENCE SYSTEMIC INFECTION. PATIENT WAS AMBULATING AND DISCHARGED HOME. AT TIME OF DISCHARGE, THE 34-YEAR-OLD PATIENT HAD ONLY ONGOING PROBLEMS RELATED TO TRAUMA FROM FALL, RESULTING IN STABLE PELVIC FRACTION AND C-SPINE INJURY.
Patient problems: Erythema; Fungal Infection; Hypersensitivity/Allergic reaction; Itching Sensation; Localized Skin Lesion
MAUDE report 20563430 ↗MalfunctionJun 2, 2021Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT, IT WAS NOTICED THAT THE SILICONE IS DETACHED AND REMAINS ON THE PROTECTIVE PLASTIC FILM. AS A RESULT, THE BANDAGE DOES NOT STICK ANYMORE. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11918468 ↗MalfunctionMar 28, 2021Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN ALLEVYN LIFE SACRUM DRESSING WAS APPLIED FOR PRESSURE INJURY PREVENTION. WHEN THE DRESSING WAS PULLED BACK TO ASSESS THE SKIN, A LARGE AMOUNT OF SILICONE RESIDUE WAS LEFT BEHIND ON THE PATIENT'S SKIN. THE SILICONE ADHESIVE WAS TOO TACKY AS IT PULLED SOME OF THE PATIENT'S SKIN OFF, WHICH WAS VISIBLE ON THE DRESSING. DID NOT CAUSE A BREAK IN THE SKIN. TREATED WITH ZINC OXIDE BARRIER CREAM WHICH RESOLVED THE ISSUE. NO INFECTION OR OTHER ADVERSE EVENTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11580367 ↗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 11429790 ↗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 11429789 ↗MalfunctionFeb 9, 2021Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DRESSING BACK IS STICKING TO PATIENTS WHEN BEING REMOVED, POSSIBLY TEARING THE SKIN OF THE PATIENT. ANOTHER DRESSING WAS APPLIED. PATIENT INJURIES WERE NOT REPORTED. IT IS NOT CONFIRMED THAT THE 352 DRESSINGS REPORTED FAILED, QUERY HAS BEEN SENT AND IF FURTHER INFORMATION IS RECEIVED THIS CASE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11304677 ↗MalfunctionFeb 9, 2021Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DRESSING BACK IS STICKING TO PATIENTS WHEN BEING REMOVED, POSSIBLY TEARING THE SKIN OF THE PATIENT. ANOTHER DRESSING WAS APPLIED. PATIENT INJURIES WERE NOT REPORTED. IT IS NOT CONFIRMED THAT THE 352 DRESSINGS REPORTED FAILED, QUERY HAS BEEN SENT AND IF FURTHER INFORMATION IS RECEIVED THIS CASE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11304632 ↗MalfunctionDec 30, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT, ALLEVYN LIFE SACRUM'S SILICONE REMAINS ON THE REMOVABLE PLASTIC PART OF THE DRESSING. NO CASE REPORTED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11096391 ↗MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT, ALLEVYN LIFE SACRUM 21.6CM X 23CM PACK OF 10 DRESSINGS ARE LEAVING SHEETS OF SILICONE ALL OVER PATIENTS. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11014322 ↗MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT, ALLEVYN LIFE SACRUM 21.6CM X 23CM PACK OF 10 DRESSINGS ARE LEAVING SHEETS OF SILICONE ALL OVER PATIENTS. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11014170 ↗MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT, ALLEVYN LIFE SACRUM 21.6CM X 23CM PACK OF 10 DRESSINGS ARE LEAVING SHEETS OF SILICONE ALL OVER PATIENTS. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11013359 ↗MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT, ALLEVYN LIFE SACRUM 21.6CM X 23CM PACK OF 10 DRESSINGS ARE LEAVING SHEETS OF SILICONE ALL OVER PATIENTS. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11013348 ↗MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT, ALLEVYN LIFE SACRUM 21.6CM X 23CM PACK OF 10 DRESSINGS ARE LEAVING SHEETS OF SILICONE ALL OVER PATIENTS. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11013329 ↗InjuryDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT, ALLEVYN LIFE SACRUM 21.6CM X 23CM PACK OF 10 DRESSINGS ARE LEAVING SHEETS OF SILICONE ALL OVER PATIENTS. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11013259 ↗MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT, ALLEVYN LIFE SACRUM 21.6CM X 23CM PACK OF 10 DRESSINGS ARE LEAVING SHEETS OF SILICONE ALL OVER PATIENTS. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11013157 ↗MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT, ALLEVYN LIFE SACRUM 21.6CM X 23CM PACK OF 10 DRESSINGS ARE LEAVING SHEETS OF SILICONE ALL OVER PATIENTS. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11013081 ↗MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT, ALLEVYN LIFE SACRUM 21.6CM X 23CM PACK OF 10 DRESSINGS ARE LEAVING SHEETS OF SILICONE ALL OVER PATIENTS. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11013057 ↗MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT, ALLEVYN LIFE SACRUM 21.6CM X 23CM PACK OF 10 DRESSINGS ARE LEAVING SHEETS OF SILICONE ALL OVER PATIENTS. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11013043 ↗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 10939302 ↗MalfunctionNov 26, 2020Loss of or Failure to Bond; Difficult to Remove; Loss of or Failure to Bond; Difficult to Remove
IT WAS REPORTED THAT THE ALLEVYN DRESSING LEFT A LARGE AMOUNT OF SILICONE RESIDUES ON THE PATIENT'S SKIN. ADDITIONALLY THE CONSEQUENT LACK OF ADHERENCE WHEN REAPPLYING THE PRODUCT. NO INJURY TO PATIENT REPORTED DUE THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10912577 ↗MalfunctionNov 26, 2020Loss of or Failure to Bond; Difficult to Remove; Loss of or Failure to Bond; Difficult to Remove
IT WAS REPORTED THAT THE ALLEVYN DRESSING LEFT A LARGE AMOUNT OF SILICONE RESIDUES ON THE PATIENT'S SKIN. ADDITIONALLY THE CONSEQUENT LACK OF ADHERENCE WHEN REAPPLYING THE PRODUCT. NO INJURY TO PATIENT REPORTED DUE THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10912576 ↗MalfunctionNov 26, 2020Loss of or Failure to Bond; Difficult to Remove; Loss of or Failure to Bond; Difficult to Remove
IT WAS REPORTED THAT THE ALLEVYN DRESSING LEFT A LARGE AMOUNT OF SILICONE RESIDUES ON THE PATIENT'S SKIN. ADDITIONALLY THE CONSEQUENT LACK OF ADHERENCE WHEN REAPPLYING THE PRODUCT. NO INJURY TO PATIENT REPORTED DUE THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10912575 ↗MalfunctionNov 26, 2020Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE ALLEVYN DRESSING LEFT A LARGE AMOUNT OF SILICONE RESIDUES ON THE PATIENT'S SKIN. ADDITIONALLY THE CONSEQUENT LACK OF ADHERENCE WHEN REAPPLYING THE PRODUCT. NO INJURY TO PATIENT REPORTED DUE THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10912551 ↗MalfunctionOct 14, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT THE ALLEVYN LIFE SACRUM 21.6CM X 23CM PACK OF 10, THE DRESSING'S SILICONE IS COMING OFF IN LARGE SECTIONS ONTO THE BACKING AND ONTO THE PATIENT. 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 10679145 ↗MalfunctionOct 14, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT THE ALLEVYN LIFE SACRUM 21.6CM X 23CM PACK OF 10, THE DRESSING'S SILICONE IS COMING OFF IN LARGE SECTIONS ONTO THE BACKING AND ONTO THE PATIENT. 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 10679127 ↗
Other Dressing, Wound, Occlusive devices
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- DUODERM 187662Convatec, Purchasing Department · Dressing, Wound, Occlusive43 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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