MAUDE Adverse Event Report: ASO AMERICAS, S. DE R. L. DE C. V. KROGER; WATERPROOF STRONG STRIPS BANDAGES HEAVY DUTY ANTIBACTERIAL ALL ONE SIZE

Model Number	UPC#041260384011
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	09/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of 09/23/2024 returned product and 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.Refer to section b.6 of this report for further details.Udi notes: the expiry date is not present on the device label.
Event or Problem Description
On the initial report received by aso on 08/21/2024, the consumer stated that the product caused a burn and the skin to peel on her face.On the completed consumer information report (cir) received on 09/03/2024, the consumer states hat the product burned and blistered her face.The consumer states the issue was with the tape and the pad area.The consumer called the nurse hotline, and she was told to clean around the area and let it heal.

• Brand Name: KROGER
• Common Device Name: WATERPROOF STRONG STRIPS BANDAGES HEAVY DUTY ANTIBACTERIAL ALL ONE SIZE
• Manufacturer (Section D): ASO AMERICAS, S. DE R. L. DE C. V.; centro industrial juarez; rio michigan, 9730; juarez, chihuahua 32648 ; MX 32648
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd; sarasota FL
• Manufacturer Contact: 300 sarasota center blvd.
• MDR Report Key: 20301688
• Report Number: 1038758-2024-00024
• Device Sequence Number: 12694323
• Product Code: KGX
• UDI-Device Identifier: 00041260384011
• UDI-Public: 00041260384011
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/25/2024

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#041260384011
• Device Lot Number: 00177712
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• 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
• Patient Sex: Female