BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIG LOTS

    MDR report key: 4294654 · Received November 25, 2014

    Report

    Report Number
    1038758-2014-00039
    Event Type
    Injury
    Date Received
    November 25, 2014
    Report Date
    November 25, 2014
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    (B)(6) 2014: PRODUCT LEFT A BURN TYPE MARK ON A BURN WOUND LEAVING BLISTERS, BUMPS AND RED MARKS. CUSTOMER REPORTED THAT OTHER FAMILY MEMBERS USED THE PRODUCT FROM THE SAME BOX WITH NO ISSUES REPORTED. CUSTOMER NOTED "MAYBE SHE HAS SENSITIVE SKIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766638 BIG LOTS ADHESIVE BANDAGE KGX ASO LLC UPC 017276228434 5611-3

    Patients

    Seq Age Sex Outcome Treatment
    1