ALLEVYN THIN 10X10CM CTN 5 66047578Recalls & reported problems
Smith & Nephew Medical Limited · Self-Adhesive Polyurethane Dressing · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05000223452919), received between Oct 13, 2020 and Mar 2, 2022 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).
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
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Delivered as Unsterile Product1
- Material Deformation1
Patient problems
- Injury1
- No Clinical Signs, Symptoms or Conditions1
- Purulent Discharge1
- Skin Disorders1
- Unspecified Infection1
- Wound Dehiscence1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE PACKAGE OF ALLEVYN THIN WAS FOUND OPEN WHEN IT WAS GOING TO BE USED TO FIX THE CATHETER. BACK UP DEVICE WAS AVAILABLE. NO HARM TO THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13656155 ↗InjuryJan 6, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT, PATIENT WAS ADMITTED TO THE HOSPITAL BECAUSE OF A LEFT HIP TRAUMA AND PAIN WITH MOVEMENT DISORDER. IN ORDER TO PROTECT THE PATIENT'S BOTTOM SKIN, ALLEVYN THIN 10X10CM CTN 5 WAS USED. WHEN THE PATIENT CHANGED HIS POSITION, THE DRESSING WAS CURLED, CAUSING THE RIGHT BUTTOCKS SKIN 3CM*4CM AVULSION. AFTER DISINFECTING THE WOUND, VASELINE GAUZE WAS USED, AND THEN THE PATIENT REQUIRED TO BE DISCHARGED.
Patient problems: Skin Disorders; Wound Dehiscence
MAUDE report 13176168 ↗InjuryNov 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON THE LITERATURE ARTICLE NAMED "CLINICAL EFFECT OF THIN COMBINED WITH CALCIUM ALGINATE DRESSING IN PREVENTING EARLY COMPLICATIONS AFTER PICC CATHETERIZATION IN ELDERLY TUMOR PATIENTS", IT WAS REPORTED THAT, WHEN USING A COMBINATION OF AN ALGISITE AND ALLEVYN THIN DRESSINGS APPLIED ON A PCC CATHETER INSERTION SITE FOR TUMOR TREATMENT IN ELDERLY PATIENTS, THE PUNCTURE SITE OF ONE PATIENT BECAME INFLAMED AND INFECTED, AS THERE WAS A PURULENT DISCHARGE PRESENT. ADDITIONAL DETAILS ON HOW THIS ADVERSE EVENT WAS TREATED ARE UNKNOWN. THE PATIENT OUTCOME IS UNKNOWN.
Patient problems: Purulent Discharge; Unspecified Infection
MAUDE report 12733698 ↗InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DRESSING WAS CUT INTO SPECTACLES SHAPE, SKIN BLEEDING, SKIN OFF WAS FOUND 1 HOUR LATER AFTER THE SURGERY. THE DOCTOR IMMEDIATELY UNCOVERED THE DRESSING, AND REMOVED THE DRESSING AND ALSO THE SKIN ADHERED. THE REST SCATTERED IN THE PURPLE APPEARED AFTER APPLYING THE DRESSING. THE PATIENT DENIED ALLERGY HISTORY. THE PATIENT PRESENTED WITH BILATERAL NASAL CONGESTION 2 YEARS AGO. SHE WAS ADMITTED TO HOSPITAL FOR NASAL SEPTUM DEVIATION ON (B)(6) 2020.
Patient problems: Injury
MAUDE report 10673695 ↗
Other Dressing, Wound, Occlusive devices
- DUODERM 187957Convatec, Purchasing Department · Dressing, Wound, Occlusive4,342 reports
- DUODERM 187955Convatec, Purchasing Department · Dressing, Wound, Occlusive1 recall2,348 reports
- DUODERM 187660Convatec, Purchasing Department · Dressing, Wound, Occlusive207 reports
- DUODERM 187961Convatec, Purchasing Department · Dressing, Wound, Occlusive153 reports
- SAM Chest Seal CS203-ENSAM Medical Products · Dressing, Wound, Occlusive1 recall0 reports
- FORWARD Gunshot Wound Kit ATF-GSWIntegrated Medcraft LLC · Dressing, Wound, Occlusive1 recall0 reports
- DUODERM 187662Convatec, Purchasing Department · Dressing, Wound, Occlusive43 reports
- ALLEVYN LIFE L 15.4X15.4 CTN10 66801069Smith & Nephew Medical Limited · Dressing, Wound, Occlusive28 reports
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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