BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IONTOPHORESIS SWEAT CHLORIDE GIBSON COOKE SWEAT TEST APPARAT

    MDR report key: 813719 · Received January 9, 2007

    Report

    Report Number
    813719
    Event Type
    Malfunction
    Date Received
    January 9, 2007
    Date of Event
    December 1, 2006
    Report Date
    January 9, 2007
    Manufacturer
    FARRALL INSTRUMENTS
    Product Code
    KTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING SWEAT TESTING (IONTOPHORESIS - SWEAT CHLORIDE.) RIGHT ARM TESTED WITHOUT DIFFICULTY. DURING TEST OF LEFT ARM, CHILD BEGAN TO CRY. WHEN THE ELECTRODE WAS REMOVED, THE ARM APPEARED TO BE BURNED WITH BLACK PINHOLE MARKS AND WELTS ON ARM UNDER ELECTRODE AREA AND OUT FROM AROUND ELECTRODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IONTOPHORESIS SWEAT CHLORIDE GIBSON COOKE SWEAT TEST APPARAT SENSOR, SWEAT TESTER KTB FARRALL INSTRUMENTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 22 MO