3M™ Tegaderm™ 9534HPRecalls & reported problems
3m Company · 3M™ Tegaderm™ HP Transparent Film Dressing, 9534HP, Chinese Language, 2-3/8 in X 2-3/4 in (6 cm X 7 cm), 100/ct 4ct/Case · 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 30707387807550), received between Aug 22, 2023 and Aug 22, 2023 — 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
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 22, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
A USER FACILITY REPORTED TO 3M A PEDIATRIC PATIENT DEVELOPED SLIGHT REDNESS, SWELLING AND A SMALL NUMBER OF BLISTERS AROUND THE PUNCTURE SITE OF THE INDWELLING NEEDLE AFTER USE OF 3M¿ TEGADERM¿ DRESSING 9534HP FOR IV SECUREMENT. THE FOUR YEARS AND SEVEN MONTHS OLD MALE PATIENT WAS ADMITTED TO THE HOSPITAL FOR COUGHING FOR FIVE DAYS. THE SYMPTOMS STARTED AFTER THREE DAYS OF WEAR. THE SKIN WAS DISINFECTED WITH IODINE. THE FOLLOWING DAY THE MOTHER OF THE PATIENT REPORTED BRINGING HER CHILD TO THE HOSPITAL AND FOUND THE SKIN AROUND THE PUNCTURE SITE OF THE INDWELLING NEEDLE HAD LARGE REDNESS, SWELLING AND MANY BLISTERS. A DERMATOLOGIST WAS CONSULT AND A WET COMPRESS WITH SALINE WAS APPLIED TO THE SITE. HYDROCORTISONE BUTYRATE CREAM AND MUPIROCIN OINTMENT WAS PRESCRIBED FOR TWO TOPICAL APPLICATIONS DAILY AND THE SYMPTOMS STARTED TO IMPROVE.
Patient problems: Blister; Erythema; Swelling/ Edema
MAUDE report 17595643 ↗
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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
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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
- ALLEVYN LIFE SACRUM (LARGE) PACK OF 10 66801307Smith & 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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