REPLICaRE THIN DRESS 3.5X5.5IN 59484100Recalls & reported problems
Smith & Nephew Medical Limited · Thin hydrocolloid wound dressing · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00040565115566), received between Oct 30, 2021 and Nov 1, 2021 — classified as 3 injuries.
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 Problem3
Patient problems
- Skin Erosion3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING WOUND TREATMENT WITH REPLICARE THIN DRESS 3.5X5.5IN, ON FOLLOW UP VISIT, SUBSTANTIAL EXCORIATION WAS NOTED ON ONE PATIENT. THE USAGE OF THE DRESSING WAS SUSPENDED IMMEDIATELY. THE TREATMENT WAS COMPLETED USING A VAC THERAPY, AND THE PATIENT RECEIVED STEROIDS AND ANTIFUNGAL ORAL MEDICATIONS TO TREAT THE EXCORIATION. NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: Skin Erosion
MAUDE report 12734042 ↗InjuryOct 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING WOUND TREATMENT WITH REPLICARE THIN DRESS 3.5X5.5IN, ON FOLLOW UP VISIT, SUBSTANTIAL EXCORIATION WAS NOTED ON ONE PATIENT. THE USAGE OF THE DRESSING WAS SUSPENDED IMMEDIATELY. THE TREATMENT WAS COMPLETED USING A VAC THERAPY, AND THE PATIENT RECEIVED STEROIDS AND ANTIFUNGAL ORAL MEDICATIONS TO TREAT THE EXCORIATION. NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: Skin Erosion
MAUDE report 12725471 ↗InjuryOct 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING WOUND TREATMENT WITH REPLICARE THIN DRESS 3.5X5.5IN, ON FOLLOW UP VISIT, SUBSTANTIAL EXCORIATION WAS NOTED ON ONE PATIENT. THE USAGE OF THE DRESSING WAS SUSPENDED IMMEDIATELY. THE TREATMENT WAS COMPLETED USING A VAC THERAPY, AND THE PATIENT RECEIVED STEROIDS AND ANTIFUNGAL ORAL MEDICATIONS TO TREAT THE EXCORIATION. NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: Skin Erosion
MAUDE report 12725470 ↗
Other Dressing, Wound, Occlusive devices
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- 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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