TopCare health 036800403086Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00036800403086), received between Nov 18, 2025 and Nov 18, 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE INITIAL REPORT RECEIVED ON OCTOBER 21, 2025, THE CONSUMER STATED THAT SHE HAD A BIOPSY AND USED THE WATERPROOF STRONG STRIP BANDAGES TO PROTECT THE WOUND. HOWEVER, SHE STATED THAT WATER ENTERED THE WOUND WHILE SHE WAS IN A HOT TUB, RAISING CONCERNS FOR AN INFECTION. ON A FOLLOW-UP MESSAGE RECEIVED ON OCTOBER 23, 2025, THE CONSUMER STATED THAT THE INCISION HAD BECOME RED AND WAS SPREADING. ON OCTOBER 24, 2025, SHE CONTACTED ASO STATING THAT SHE HAD AN APPOINTMENT SCHEDULED WITH HER DOCTOR REGARDING HER INCISION. HOWEVER, SHE WAS PLANNING TO SEE THE DOCTOR SOONER BECAUSE HER INCISION HAD NOW BECOME RED AND THE REDNESS WAS SPREADING. ON THE COMPLETED CONSUMER INFORMATION REPORT (CIR) RECEIVED ON NOVEMBER 11, 2025, THE CONSUMER SPECIFIED THAT WATER ENTERED THE WOUND AROUND THE SHORT SIDES OF THE TAPE AREA. SHE CONFIRMED THAT THE SKIN BECAME RED AND SHE REQUIRED DERMATOLOGIST TREATMENT. THE CONSUMER STATED THAT THE ISSUE WAS WITH THE SHORT SIDES OF THE TAPE AREA AND THAT THE SYMPTOMS DID NOT RESOLVE AFTER SHE STOPPED USING THE PRODUCT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 23584885 ↗