BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTE

    MDR report key: 1411798 · Received June 24, 2009

    Report

    Report Number
    1411798
    Event Type
    Malfunction
    Date Received
    June 24, 2009
    Date of Event
    April 29, 2009
    Report Date
    June 24, 2009
    Manufacturer
    CHATTANOOGA GROUP INC
    Product Code
    IPF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED ELECTRICAL STIMULATION TO RIGHT SHOULDER. SHORTLY AFTER APPLICATION, HE REPORTED IT WAS "HOT." DEVICE WAS TURNED DOWN TO COMFORT LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORTE STIMULATOR, MUSCLE, POWERED IPF CHATTANOOGA GROUP INC FORTE 400 COMBO *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR