TopCare health 036800402997Recalls & reported problems
Topco Associates, LLC · Sterile, Antibacterial Fabric Bandages, all one size, 3/4 IN x 3 IN · 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 00036800402997), received between Aug 6, 2025 and Aug 6, 2025 — classified as 1 injury.
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
Patient problems
- Blister1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE INITIAL REPORT RECEIVED BY ASO ON JUNE 25, 2025, THE CONSUMER STATED THAT THE PRODUCT CAUSED HIM TO BREAK OUT WITH BLISTERS. ON THE COMPLETED CONSUMER INFORMATION REPORT (CIR) RECEIVED ON JULY 11, 2025, THE CONSUMER REPORTED THAT HE DEVELOPED BLISTERS AND EXPERIENCED SOME BLEEDING EVERY TIME HE APPLIED THE BANDAGES. THE DOCTOR PRESCRIBED HYDROCORTISONE CREAM FROM THE PHARMACY. ADDITIONALLY, THE CONSUMER REPORTED THAT THE ISSUE WAS WITH THE TAPE AREA AND THAT THE SYMPTOMS CORRECTED AFTER HE STOPPED USING THE PRODUCT.
Patient problems: Blister; Skin Inflammation/ Irritation
MAUDE report 22725590 ↗
Other Tape And Bandage, Adhesive devices
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- CURAD NON25600QSMedline Industries, Inc. · Tape and bandage, adhesive1 recall2 reports
- IV3000-1-HAND 6X7CM-CARTON OF 100 66024007Smith & Nephew Medical Limited · Tape And Bandage, Adhesive52 reports
- 3M™ 1500U3m Company · Tape and bandage, adhesive1 recall1 report
- CURAD NON25650QSMedline Industries, Inc. · Tape and bandage, adhesive1 recall1 report
- CURAD NON256133QSMedline Industries, Inc. · Tape and bandage, adhesive1 recall0 reports
- CURAD NON25660QSMedline Industries, Inc. · Tape and bandage, adhesive1 recall0 reports
- Seer Home SM-01-9005Seer Medical Holdings Limited · Tape And Bandage, Adhesive1 recall0 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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