BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMCARE CARBON FOAM 2 INCH X 2 INCH SQUARE, 4 PACK

    MDR report key: 4811566 · Received June 2, 2015

    Report

    Report Number
    1721293-2015-00003
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    April 27, 2015
    Report Date
    May 5, 2015
    Manufacturer
    EMPI, INC
    Product Code
    GXY
    PMA / PMN Number
    K902195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTRODES WERE EVALUATED AND NO FAILURES WERE FOUND, THE ELECTRODES WERE WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE ELECTRODE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS BURNED USING EMPI ELECTRODES. THE TREATMENT WAS FOR PAIN CONTROL, AND OSTEOARTHRITIS FLARE-UP. THE PROGRAM ON THE DEVICE USED WAS TENS FOR KNEE, THE INTENSITY WAS MODERATE TO STRONG. THE ELECTRODES WERE PLACED ON THE RIGHT KNEE BOTH MEDIAL AND LATERAL AND 3-4 INCHES APART. THE TREATMENT LASTED 15 MINUTES AND 2 CHANNELS WERE USED. THE BURN WAS NOTICED BY THE PATIENT WHEN SHE GOT HOME. THE BURN WAS DIAGNOSED AS BEING 3RD DEGREE AND THE PATIENT WAS TREATING THE BURN WITH NEOSPORIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354440 STIMCARE CARBON FOAM 2 INCH X 2 INCH SQUARE, 4 PACK STIMCARE CARBON ELECTRODES GXY EMPI, INC 86905220 432515

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other