BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOPCO

    MDR report key: 5240977 · Received November 20, 2015

    Report

    Report Number
    1038758-2015-00100
    Event Type
    Injury
    Date Received
    November 20, 2015
    Report Date
    October 21, 2015
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETAINED AND RETURNED SAMPLES FROM THE SAME LOT WERE EVALUATED FOR ADHESION PROPERTIES AS WELL AS REVIEWING EXISTING BIOCOMPATIBILITY ON FILE. A REVIEW OF THE TEST RESULTS DID NOT REVEAL ANY ISSUES WITH THE SAMPLES EVALUATED.

    Description of Event or Problem · 1

    ON (B)(6) 2015 - THE END USER ALLEGED THE DEVICE CAUSED AN ALLERGIC REACTION TO HIS SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770214 TOPCO SHEER ADHESIVE BANDAGES KGX ASO LLC UPC036800403093 05302020

    Patients

    Seq Age Sex Outcome Treatment
    1