BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRO-TRAC

    MDR report key: 19584945 · Received June 20, 2024

    Report

    Report Number
    MW5156444
    Event Type
    Injury
    Date Received
    June 20, 2024
    Date of Event
    March 22, 2024
    Report Date
    June 16, 2024
    Manufacturer
    PNEUMEX, INC.
    Product Code
    JFB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS IN CHIROPRACTOR'S OFFICE RECEIVING DECOMPRESSION TREATMENT FOR LUMBAR SPINE ON VIBRO-TRAC DECOMPRESSION TABLE. PLASTIC FASTENER ON CABLE BROKE UNDER TENSION ON THE TABLE. THIS CAUSED THE HEAD TRACTION BAR TO SWING UP AND STRIKE ME IN THE HEAD. IT CAUSED LACERATIONS AND CONTUSIONS IN 3 DIFFERENT AREAS OF THE SCALP. I WENT TO A NEARBY URGENT CARE CENTER FOR EVALUATION. THE MACHINES ARE MADE BY PNEUMEX INC. OF SANDPOINT, IDAHO. THE DEVICE IS IN THE CHIROPRACTOR'S OFFICE IN (B)(6). DEVICE IS IN THE CHIROPRACTOR'S OFFICE; IT IS NOT A PORTABLE DEVICE AND NOT INTENDED FOR CONSUMER USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2178234 VIBRO-TRAC TABLE, PHYSICAL THERAPY, MULTI FUNCTION JFB PNEUMEX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other CALCIUM.| CLARITIN.| EPA/DHA (OMEGA-3).| GLUCOSAMINE.| MSM (METHYLSULFONYLMETHANE).| NAPROXEN.| PSEUDOPHEDRINE.| QUERCETIN.| VITAMIN D.