BEUDAMED
    FDA Adverse Event Other Summary report: N

    GVII

    MDR report key: 624991 · Received August 5, 2005

    Report

    Report Number
    2126518-2005-00002
    Event Type
    Other
    Date Received
    August 5, 2005
    Date of Event
    July 16, 2005
    Report Date
    August 4, 2005
    Manufacturer
    REHABILICARE INC
    Product Code
    EZW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED BURN UNDER ELECTRODE DURING TREATMENT OF ELECTRICAL STIMULATION. PATIENT WENT TO EMERGENCY ROOM AND PHYSICIAN TREATED WITH ANTIBIOTIC AND OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GVII HIVOLT PULSED GALVANTIC STIMULATOR EZW REHABILICARE INC 10005 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other