TopCare health 036800467187Recalls & reported problems
Topco Associates, LLC · Advanced All-Purpose Fast Healing Hydrocolloid Gel Bandages, all one size, 0.78 IN x 2.36 IN (2.0 cm x 6.0 cm) · Class 1
Data updated Oct 18, 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 00036800467187), received between Oct 3, 2024 and Oct 3, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Off-Label Use” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Off-Label Use1
Patient problems
- Abrasion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 3, 2024Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem
ON THE INITIAL REPORT DATED 07/22/2024, THE CONSUMER STATED THAT THE PRODUCT TORE OFF HER SKIN, AND SHE HAD TO GO TO MEDI MERGE TO TREAT IT. ON THE COMPLETED CIR RECEIVED FROM THE CONSUMER ON 09/09/2024, THE CONSUMER STATES THAT THE BANDAGE ON HER SKIN WAS FINE FOR A DAY, THEN PARTIALLY LOOSENED. WHEN SHE TRIED TO REMOVED IT AFTER ONE DAY, IT RIPPED HER SKIN OFF, AND SHE ENDED UP WITH AN OPEN WOUND. SHE HAD TO GO TO MED MERGE CENTER TO HAVE THE WOUND CLEANED AND TREATED.
Patient problems: Abrasion
MAUDE report 20363405 ↗
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- DUODERM 187961Convatec, Purchasing Department · Dressing, Wound, Occlusive153 reports
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- 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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