MAUDE Adverse Event Report: ASO AMERICAS, S. DE R. L. DE C. V. KROGER; ADVANCED ANTIBACTERIAL PLASTIC BANDAGES ALL ONE SIZE

Model Number	UPC#041260384097
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	07/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of 08/06/2025, 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
According to the initial report received by aso on june 25, 2025, the consumer states that the bandages caused her two sores.On the completed cir received by aso on july 29, 2025, the consumer states that she used the bandages to cover a sore on the inside of her right ankle to protect it.After one day, she removed the bandage, and her skin came off with the bandage.Consumer stated that the issue was with the tape area and that the symptoms did not correct after she stopped using the product.Consumer informed that sore is not healing and she has been treated weekly by hca healthone wound care.

• Brand Name: KROGER
• Common Device Name: ADVANCED ANTIBACTERIAL PLASTIC BANDAGES 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 34240
• Manufacturer Contact: aso complaints ; 300 sarasota center blvd.; 9413790300
• MDR Report Key: 22772203
• Report Number: 1038758-2025-00018
• Device Sequence Number: 9449883
• Product Code: KGX
• UDI-Device Identifier: 00041260384097
• UDI-Public: 00041260384097
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 08/11/2025

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: 07/05/2023
• Device Model Number: UPC#041260384097
• Device Lot Number: 00090021
• 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: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2018
• 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