BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOPCO

    MDR report key: 3935820 · Received June 25, 2014

    Report

    Report Number
    1038758-2014-00016
    Event Type
    Other
    Date Received
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014 - THE CONSUMER REPORTED THAT SHE HAD A SEVERE ALLERGIC REACTION TO THE BANDAGES, RESULTING IN BLISTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371194 TOPCO CLEAR WATERPROOF STRONG STRIPS XL 10 CT KGX ASO LLC 36800186835 6054

    Patients

    Seq Age Sex Outcome Treatment
    1 Other