MAUDE Adverse Event Report: ASO LLC AMAZON BASIC+CARE; ANTIBACTERIAL SHEER ADHESIVE PADS

Model Number	UPC#195515047098
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
In the initial report received on (b)(6) 2025, the consumer stated that the bandage caused a burn on the leg and that medical attention was sought.
Additional Manufacturer Narrative
As of 07/09/2025 retained samples were submitted to the lab with no defects noted.In addition, aso reviewed records of satisfactory biocompatibility tests for this type of product with no issues noted.Udi notes: the expiry date is not present on the device label.

• Brand Name: AMAZON BASIC+CARE
• Common Device Name: ANTIBACTERIAL SHEER ADHESIVE PADS
• 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.; sarasota, FL 34240
• MDR Report Key: 22457360
• Report Number: 1038758-2025-00014
• Device Sequence Number: 12834975
• Product Code: KGX
• UDI-Device Identifier: 00195515047098
• UDI-Public: 00195515047098
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 07/09/2025

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 Model Number: UPC#195515047098
• Device Catalogue Number: ITEM # B07D1DGQFV
• Device Lot Number: 232605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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: Unknown