BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCEL

    MDR report key: 881690 · Received July 11, 2007

    Report

    Report Number
    MW5003055
    Event Type
    Malfunction
    Date Received
    July 11, 2007
    Date of Event
    May 25, 2007
    Report Date
    July 10, 2007
    Manufacturer
    EXCEL TECH, LTD.
    Product Code
    GZJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER ERROR - EXCEL MUSCLE STIMULATOR HAD ELECTRODE PAD THAT WAS NOT COMPATIBLE WITH THE CABLE. AS INTENSITY WAS TURNED UP ON STIMULATOR, SETTING STAYED AT "0" AND THEN SUDDENLY CAME ON AND SHOCKED PT. NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCEL MUSCLE STIMULATOR GZJ EXCEL TECH, LTD. EXCEL MULTI 3 OUR BIO MED TAG -250-04500

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR