BEUDAMED
    FDA Adverse Event Other Summary report: N

    FORTE CPS 200 COMBO

    MDR report key: 1060940 · Received June 11, 2008

    Report

    Report Number
    1022819-2008-00166
    Event Type
    Other
    Date Received
    June 11, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 29, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING RETURN AND EVAL OF THE DEVICE.

    Description of Event or Problem · 1

    PT RECEIVED A SKIN BURN DURING TREATMENT WITH DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORTE CPS 200 COMBO POWERED MUSCLE STIMULATOR IPF CHATTANOOGA GROUP CPS003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other