BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCEL MULTI III

    MDR report key: 5130028 · Received August 6, 2004

    Report

    Report Number
    5130028
    Event Type
    Injury
    Date Received
    August 6, 2004
    Date of Event
    July 29, 2004
    Report Date
    August 6, 2004
    Manufacturer
    EXCEL TECH LTD
    Product Code
    GZJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE S/P RIGHT TOTAL KNEE REPLACEMENT. WAS UNDERGOING ICF AT 33 MICRO AMPS X 10 MINS WHEN HE COMPLAINED OF SUDDEN PAIN. THE GAUGE ON THE MACHINE HAD INCREASED ON ITS OWN TO 50 MICRO AMPS. IMMEDIATELY TURNED OFF MACHINE. EXAMINED ELECTRODE AND NO BREAK IN CONDUCTION GEL. TEN CENT SIZE AREA LATERAL RIGHT KNEE. AN ELECTRODE ALSO USED 'UNIPATCH'. TYCO HEALTHCARE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCEL MULTI III ELECTROTHERAPY (MUSCLE STIMULATOR) GZJ EXCEL TECH LTD MS-7 125

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other