BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELBAND TENNIS ELBOW ARM BAND

    MDR report key: 647093 · Received November 14, 2005

    Report

    Report Number
    1044691-2005-00001
    Event Type
    Other
    Date Received
    November 14, 2005
    Date of Event
    October 15, 2005
    Report Date
    November 14, 2005
    Manufacturer
    FLA ORTHOPEDICS, INC.
    Product Code
    IOY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO A LETTER RECEIVED FROM THE PT'S ATTORNEY, THE PT FOLLOWED THE DIRECTIONS THAT CAME WITH THE GELBAND ARM BAND FOR HEATING THE THERMAL HOT PACK IN THE MICROWAVE FOR 15 SECONDS. WHEN HE REACHED IN THE MICROWAVE TO GRAB THE GEL PACK, IT BURST AND THE GEL AHERED TO HIS RIGHT INDEX FINGER AND HAND. THE PT WENT TO THE EMERGENCY ROOM WHERE HE WAS INFORMED HE SUSTAINED SECOND TO THIRD DEGREE BURNS TO HIS FINGERS AND HAS SINCE BEEN REFERRED TO AN ORTHOPEDIC HAND SPECIALIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELBAND TENNIS ELBOW ARM BAND ARM SUPPORT, TENNIS ELBOW STRAP 890.3475 IOY FLA ORTHOPEDICS, INC. 19-500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other