BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RYAN 102C REUSABLE ELECTRODES

    MDR report key: 648653 · Received December 2, 2005

    Report

    Report Number
    1531212-2005-00001
    Event Type
    Injury
    Date Received
    December 2, 2005
    Date of Event
    September 1, 2005
    Report Date
    November 2, 2005
    Manufacturer
    MEDI-SOURCE, INC.
    Product Code
    GXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A PATIENT REPORTEDLY RECEIVED A SMALL "CIGARETTE SIZED" BURN ASSOCIATED WITH THE USE OF ANOTHER MANUFACTURER'S INTERFERENTIAL STIMULATOR WITH THIS MANUFACTURERS 2"X4" REUSABLE TENS/NMS ELECTRODES. THE SEVERITY OF THE "BURN" WAS NOT ABLE TO BE DETERMINED. HOWEVER THE PATIENT REPORTEDLY SOUGHT TREATMENT AT A LOCAL HOSPITAL ER. THE NATURE OF THE TREATMENT RECEIVED IS UNKNOWN. THE PATIENT SUBSEQUENTLY RETURNED TO THE PHYSICAL THERAPY CENTER PRESENTING WITH A SMALL RED MARK ON THE LOWER BACK AND CONTINUED STIMULATION THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RYAN 102C REUSABLE ELECTRODES SINGLE PATIENT USE REUSABLE ELECTRODES GXY MEDI-SOURCE, INC. 3490407BCTP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention