BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERILE PADS 3" X 3"

    MDR report key: 1977775 · Received January 30, 2011

    Report

    Report Number
    MW5019216
    Event Type
    Injury
    Date Received
    January 30, 2011
    Date of Event
    January 29, 2011
    Report Date
    January 30, 2011
    Manufacturer
    ASO LLC
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AE, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD BEEN USING STERILE PADS GIVEN TO US BY THE (B)(6) CARE CLINIC TO COVER PUNCTURES AND SCRAPES FROM A DOG BITE ON MY SON'S LEG. I PURCHASED EXCHANGE SELECT STERILE PADS - MANUFACTURER: ASO LLC, (B)(4) - WHEN I NEEDED MORE. I HAVE BEEN USING THE EXCHANGE SELECT PADS FOR ONE DAY. I USED ONE ON THE EVENING OF THE (B)(6) AND ONE ON THE MORNING OF THE (B)(6). YESTERDAY EVENING, HE BEGAN COMPLAINING OF ITCHING UNDER THE BANDAGE. WHEN I REMOVED THE BANDAGE, THERE WAS RASH FROM CONTACT DERMATITIS DIRECTLY UNDER, AND IN THE SHAPE OF THE PAD. I CLEANED THE AREA WELL AND USED A DIFFERENT BRAND OF PAD FROM OUR FIRST AID KIT. THE RASH IS NOW CLEARING UP. WHILE THIS IS NOT A LIFE-THREATENING REACTION, I WOULD LIKE TO UNDERSTAND WHY THE EXCHANGE SELECT PADS CAUSED A RASH - SOMETHING HE HARDLY NEEDED ON TOP OF THE DOG BITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERILE PADS 3" X 3" STERILE PADS 3" X 3" FRO ASO LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other