BEUDAMED
    FDA Adverse Event Other Summary report: N

    FORTE ES

    MDR report key: 546622 · Received September 28, 2004

    Report

    Report Number
    546622
    Event Type
    Other
    Date Received
    September 28, 2004
    Date of Event
    July 15, 2004
    Report Date
    September 27, 2004
    Manufacturer
    CHATTANOOGA GROUP, INC.
    Product Code
    IPF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS RECEIVING PRE-MODULATED ELECTRICAL STIMULATION AT 80-150 MHZ USING (4) 2 INCH SQUARE ELECTRODES LOCTED ON RIGHT POSTERIOR SHOULDER, RIGHT TRICEPS AND 2 ON THEIR MEDIAL FOREARM. THE TREATMENT WAS COMPLETED AND THE PT LEFT. PT RETURNED ONE-HALF HR LATER WITH 3 BURN MARKS ON THEIR RIGHT TRICEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORTE ES ELECTRICAL STIMULATOR IPF CHATTANOOGA GROUP, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other ELECTRODES.