BEUDAMED
    FDA Adverse Event Other Summary report: N

    OUR FAMILY

    MDR report key: 3397226 · Received October 1, 2013

    Report

    Report Number
    1038758-2013-00036
    Event Type
    Other
    Date Received
    October 1, 2013
    Report Date
    October 1, 2013
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 - CARETAKER REPORTED THAT HER SON HAD AN ALLERGIC REACTION TO THE DEVICE USED TO COVER A BUG BITE. END USER DEVELOPED IMPETIGO WHICH RESULTED IN PHYSICIAN VISIT, ORAL ANTIBIOTIC AND STEROID CREAM. SYMPTOMS CORRECTED WITH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494768 OUR FAMILY FABRIC BANDAGES KGX ASO LLC 070263962790 4 4/13 5240-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other