BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IV PREP WIPES BOX OF 50

    MDR report key: 5000841 · Received August 13, 2015

    Report

    Report Number
    3006760724-2015-00075
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    August 7, 2015
    Report Date
    August 7, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KOX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 MONTHS AGO THAT WHILE USING THE PRODUCT, THE PATIENT EXPERIENCED BLISTERS, ITCHY AND FLUID OOZING FORM THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534564 IV PREP WIPES BOX OF 50 SOLVENT, ADHESIVE TAPE KOX SMITH & NEPHEW, INC. 59421200

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR