BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEGEND STIM

    MDR report key: 1012386 · Received March 7, 2008

    Report

    Report Number
    1022819-2008-00067
    Event Type
    Other
    Date Received
    March 7, 2008
    Date of Event
    February 11, 2008
    Report Date
    March 6, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    GZJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING RETURN AND EVALUATION OF DEVICE.

    Description of Event or Problem · 1

    PATIENT RECEIVED BURN DURING ELECTROTHERAPY TREATMENT. THE BURN LOCATION WAS REPORTED TO BE ADJACENT TO THE ELECTRODE LEAD WIRE CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGEND STIM POWER MUSCLE STIMULATOR GZJ CHATTANOOGA GROUP INT02R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other