BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2192411 · Received August 1, 2011

    Report

    Report Number
    2192411
    Event Type
    Malfunction
    Date Received
    August 1, 2011
    Date of Event
    July 19, 2011
    Report Date
    August 1, 2011
    Manufacturer
    WESCOR, INC.
    Product Code
    KTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    WHILE TECH WAS PERFORMING A SWEAT TEST ON PATIENT'S LEG, GEL DISK CRACKED AND PATIENT RECEIVED A SMALL BURN 2CMX2CM AREA. PT STARTED TO CRY, TECH CHECKED SITE AND NOTICED THIS, STOPPED TESTING, APPLIED A&D OINTMENT AND NOTIFIED RN, WHICH IN TURN NOTIFIED PHYSICIAN. THEY ORDERED BACITRACIN, THEN ORDERED SILVADENE BID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * GEL DISC FOR SWEAT TEST KTB WESCOR, INC. * 200561

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO