BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOLLAR GENERAL FABRIC 3 ASSORTED 30CT. BANDAGES

    MDR report key: 5006597 · Received August 13, 2015

    Report

    Report Number
    1038758-2015-00063
    Event Type
    Injury
    Date Received
    August 13, 2015
    Report Date
    August 12, 2015
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) /2015, THE GRANDMOTHER OF THE END USER REPORTED THAT DEVICE RIPPED THE SKIN OFF AND LEFT AN IMPRINT OF THE DEVICE ON THE CHILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536528 DOLLAR GENERAL FABRIC 3 ASSORTED 30CT. BANDAGES ADHESIVE BANDAGES KGX ASO LLC UPC 017276226140

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO