BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KROGER

    MDR report key: 20301688 · Received September 25, 2024

    Report

    Report Number
    1038758-2024-00024
    Event Type
    Injury
    Date Received
    September 25, 2024
    Date of Event
    September 3, 2024
    Report Date
    September 25, 2024
    Manufacturer
    ASO AMERICAS, S. DE R. L. DE C. V.
    Product Code
    KGX
    UDI-DI
    00041260384011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1303735 KROGER WATERPROOF STRONG STRIPS BANDAGES HEAVY DUTY ANTIBACTERIAL ALL ONE SIZE KGX ASO AMERICAS, S. DE R. L. DE C. V. UPC#041260384011 00177712 00041260384011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other