Equate 681131006736Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00681131006736), received between Jan 29, 2025 and Sep 9, 2025 — classified as 3 injuries.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 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 (B)(6) 2025, THE CONSUMER STATED THAT THE BANDAGES CAUSED AN ALLERGIC REACTION (RASH) AND A CHEMICAL BURN, AND THE BANDAGE ALSO STUCK TO HER SKIN, MAKING IT DIFFICULT TO REMOVE, RESULTING IN A BRUISE. THE CONSUMER WENT TO THE DOCTOR. ON THE COMPLETED CIR RECEIVED BY ASO ON (B)(6) 2025, THE CONSUMER STATES THAT SHE USED THE BANDAGES ON TWO PLACES AND CAUSED A CHEMICAL REACTION, BURN, AND RASH WITH PUS. THE TREATMENT WAS SILVER SULFADIAZINE, AN ALLERGY TOPICAL, AND PREDNISONE. CONSUMER WENT TO URGENT CARE AND FOLLOWED UP WITH THE PRIMARY DOCTOR. CONSUMER CONFIRMED THAT THE SYMPTOMS CORRECTED AFTER SHE STOPPED USING THE PRODUCT AND TREATED THE AREA. PER CIR, THE ISSUE WAS WITH THE TAPE AND THE PAD AREA.

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 23003080 ↗
• InjuryJul 16, 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 19, 2025, THE CONSUMER STATED THAT SHE EXPERIENCED A RASH FROM THE PRODUCT. THE CUSTOMER STATES THAT SHE WILL BE CONSULTING A DOCTOR TO EXAMINE HER RASH.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22518740 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE INITIAL REPORT RECEIVED BY ASO ON 11/26/2024, THE CONSUMER STATED THAT THE PRODUCT MADE HER SKIN HARD, AND HER SKIN STARTED TO PEEL ON HER FINGER ONLY WHERE THE BANDAGE WAS. IN THE COMPLETED CONSUMER INFORMATION REPORT (CIR) RECEIVED ON 01/03/2025, THE CONSUMER STATES THAT SHE USED THE BANDAGES ON A CUT, WHICH WORSENED, AND CAUSED IRRITATION TO ALL THE SURROUNDING SKIN. THE CONSUMER STATED THAT SHE REQUIRED MEDICAL TREATMENT AND THAT THE SYMPTOMS DID NOT IMPROVE AFTER SHE STOPPED USING THE PRODUCT. CONSUMER STATED THAT THE SKIN ON HER HAND HAS HEALED, BUT IT IS EXTREMELY HARD TO BEND HER INDEX FINGER.

  Patient problems: Skin Tears

  MAUDE report 21268521 ↗