MAUDE Adverse Event Report: ASO LLC TOPCARE HEALTH; FABRIC ANTIBACTERIAL BANDAGES ALL ONE SIZE

Model Number	UPC#036800402997
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	07/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of 07/30/2025, unused returned product and retained samples were submitted to the lab for testing with no defects noted.In addition, aso reviewed records of satisfactory biocompatibility tests for this type of product with no issues noted.Refer to section b6 of this report for further details.Udi notes: the expiry date is not present on device label.
Event or Problem Description
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.

• Brand Name: TOPCARE HEALTH
• Common Device Name: FABRIC ANTIBACTERIAL BANDAGES ALL ONE SIZE
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd; sarasota FL 34240
• Manufacturer Contact: aso complaints ; 300 sarasota center blvd.; 9413790300
• MDR Report Key: 22725590
• Report Number: 1038758-2025-00017
• Device Sequence Number: 21080151
• Product Code: KGX
• UDI-Device Identifier: 00036800402997
• UDI-Public: 00036800402997
• 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): 08/06/2025

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 Expiration Date: 08/29/2025
• Device Model Number: UPC#036800402997
• Device Catalogue Number: 003680040299
• Device Lot Number: 00137352
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2020
• 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
• Patient Sex: Male