BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LO-BAK TRAX

    MDR report key: 5161667 · Received October 9, 2015

    Report

    Report Number
    MW5057178
    Event Type
    Injury
    Date Received
    October 9, 2015
    Date of Event
    October 8, 2015
    Report Date
    October 9, 2015
    Manufacturer
    NGC INDUSTRIES, INC.
    Product Code
    HST
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I BOUGHT A LO-BAK TRAX, AND THE INSTRUCTION MANUAL STATES "THE LO-BAK TRAX LOGO IS ON THE RIGHT SIDE HANDLE DURING USE." THERE IS A PHOTO OF THE DEVICE, CLEARLY SHOWING THE "RIGHT HANDLE" ON THE SIDE OF THE DEVICE WITH THE "LOGO". SO, I USED MY RIGHT HAND TO HOLD THE HANDLE ON THE SIDE WITH THE LOGO, AND HELD THE OTHER HANDLE WITH MY LEFT HAND. WHEN I APPLIED PRESSURE ON THE HANDLES, THE POINT IN THE CENTER OF THE DEVICE WAS PUSHED INTO MY CROTCH/SCROTUM, CAUSING SEVERE PAIN. I FINALLY DETERMINED THAT THE INSTRUCTIONS DO NOT MATCH THE DEVICE. THE HANDLE WITH THE PRODUCT LOGO SHOULD BE HELD WITH THE LEFT HAND, NOT THE RIGHT HAND. WHEN I HELD THE "LOGO" HANDLE WITH MY LEFT HAND, THE PRODUCT WORKED CORRECTLY. I DON'T KNOW IF THE PROBLEM IS WITH THE MANUFACTURING PROCESS (THE LOGO WAS ACCIDENTALLY PLACED ON THE WRONG SIDE OF THE DEVICE), OR IF THE PROBLEM IS WITH THE INSTRUCTIONS (ACCIDENTALLY SUBSTITUTED THE WORD "RIGHT" FOR "LEFT"), BUT THE DEVICE AND INSTRUCTIONS POSE A DEFINITE SAFETY HAZARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671193 LO-BAK TRAX NON POWERED TRACTION HST NGC INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR