MAUDE Adverse Event Report: EUROMED, INC. TOPCARE; FAST HEALING HYDROCOLLOID GEL BANDAGES

Model Number	UPC#036800467187
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of 9/30/2024 manufacturer has completed their investigation with no issues found.Aso reviewed records of biocompatibility tests with no issues noted.Refer to section b.6 of this report for further details.
Event or Problem Description
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.

• Brand Name: TOPCARE
• Common Device Name: FAST HEALING HYDROCOLLOID GEL BANDAGES
• Manufacturer (Section D): EUROMED, INC.; 25 corporate drive; orangeburg NY 10962
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• Manufacturer Contact: aso complaints ; 300 sarasota center blvd.; sarasota, FL 34240
• MDR Report Key: 20363405
• Report Number: 1038758-2024-00025
• Device Sequence Number: 3795756
• Product Code: NAD
• UDI-Device Identifier: 00036800467187
• UDI-Public: 00036800467187
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: UPC#036800467187
• Device Catalogue Number: 003680046718
• Device Lot Number: 00182709
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Other
• Patient Sex: Female