BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTELECT 4CH STIM

    MDR report key: 1016328 · Received March 21, 2008

    Report

    Report Number
    1022819-2008-00100
    Event Type
    Other
    Date Received
    March 21, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 20, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    GZJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING RETURN AND EVALUATION OF THE DEVICE. IPF SIMULATOR, MUSCLE, POWERED, 890.5858. GZI, STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL, 882.5810

    Description of Event or Problem · 1

    PT RECEIVED A BURN DURING AN ELECTROTHERAPY TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELECT 4CH STIM GZJ, STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF, 882.5810 GZJ CHATTANOOGA GROUP 7560R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other