BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KROGER

    MDR report key: 17595903 · Received August 22, 2023

    Report

    Report Number
    1038758-2023-00018
    Event Type
    Injury
    Date Received
    August 22, 2023
    Date of Event
    July 27, 2023
    Report Date
    August 22, 2023
    Manufacturer
    ASO AMERICAS, S. DE R. L. DE C. V.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF 08/18/2023 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.

    Description of Event or Problem · 0

    ON THE INITIAL REPORT RECEIVED BY ASO ON 07/13/2023, THE CONSUMER STATES THAT THE ADHESIVE ON THE BANDAGES CAUSED A RASH AND LARGE BLISTER. ON THE COMPLETED CIR RECEIVED FROM THE CONSUMER ON 07/27/2023, SHE STATED THAT SHE USED THE BANDAGES TO COVER TWO WOUNDS ON THE FRONT AND BACK OF HER ANKLE. THE CONSUMER STATED THAT THE PRODUCT LEFT INJURIES WORSE THAN THE SKIN SHE WAS HEALING WITH A PRESCRIPTION CREAM. PER CIR CONSUMER CONFIRMS THAT THE ISSUE WAS WITH THE TAPE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300772 KROGER ADVANCED ANTIBACTERIAL FLEXIBLE FABRIC BANDAGES ASSORTED SIZES KGX ASO AMERICAS, S. DE R. L. DE C. V. UPC#041260384059 00175558

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other