3M™ Tegaderm™ 9543HPRecalls & reported problems
3m Company · 3M(TM) Tegaderm(TM) HP (Holding Power) Transparent Film Dressing Frame Style 9543HP · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04001895928574), received between May 18, 2021 and May 18, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 16, 2026.
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Blister1
- Erythema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2021Patient Device Interaction Problem; Patient Device Interaction Problem
A MALE PATIENT REPORTED UNDERGOING ROBOTIC HERNIA SURGERY ON (B)(6) 2021. THREE INCISIONS WERE MADE ON HIS ABDOMEN AND COVERED WITH A 3M¿ TEGADERM¿ DRESSING. THE PATIENT REMOVED THE DRESSING 48 HOURS LATER AND ALLEGED SKIN REDNESS AND BLISTERS IN FIVE AREAS. NO MEDICAL INTERVENTIONS WERE REQUIRED. CURRENTLY THE PATIENT'S SKIN IS HEALED AND REPORTS FIVE AREAS OF SCAR LIKE SYMPTOMS.
Patient problems: Blister; Erythema
MAUDE report 11843331 ↗
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- DUODERM 187662Convatec, Purchasing Department · Dressing, Wound, Occlusive43 reports
- ALLEVYN LIFE L 15.4X15.4 CTN10 66801069Smith & Nephew Medical Limited · Dressing, Wound, Occlusive28 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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