MAUDE Adverse Event Report: ASO AMERICAS, S. DE R. L. DE C. V. KROGER; ADVANCED ANTIBACTERIAL STRONG STRIPS BANDAGES

Model Number	UPC#041260384073
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burning Sensation (2146); Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report received by aso on (b)(6) 2025, the consumer states that after using the bandages, her daughter developed a severe infection, which has caused her significant distress.On the completed consumer information report (cir) received on (b)(6) 2025, the consumer states that the product caused her daughter to develop skin erythema streaking up the arm.Caused a burn, blistering around the edge of where the bandage was.Per cir the consumer went to st.Alphonsus urgent care, where she was prescribed amoxicillin-clavulanate 875-125 mg per tablet and triamcinolone 0.1 % ointment.The consumer states that the issue was with the tape area and that the symptoms did not correct after she stopped using the product.She was left with a permanent scar.
Additional Manufacturer Narrative
As of 09/11/2025, 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 b.6 of this report for further details.Udi notes: the expiry date is not present on device label.

• Brand Name: KROGER
• Common Device Name: ADVANCED ANTIBACTERIAL STRONG STRIPS BANDAGES
• 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: 23082695
• Report Number: 1038758-2025-00023
• Device Sequence Number: 4645469
• Product Code: KGX
• UDI-Device Identifier: 00041260384073
• UDI-Public: 00041260384073
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K983368
• 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): 09/18/2025

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#041260384073
• Device Lot Number: 225453
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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