BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTABLE NECK TRACTION

    MDR report key: 756856 · Received June 20, 2006

    Report

    Report Number
    MW1040267
    Event Type
    Injury
    Date Received
    June 20, 2006
    Manufacturer
    GIBBONS HEALTH PRODUCTS, INC.
    Product Code
    HST
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PORTABLE TRACTION DEVICE WAS PLACED ON THE NECK AS INSTRUCTED. THE DEVICE HAS A PUMP, AS THE DEVICE FILLED WITH AIR, IT CAUSED A SENSATION OF CHOKING & PRESSURE TO THE JUGULAR VEINS WHICH CAUSED A PASSING OUT SYMPTOM. THE COMPANY HAS NOT REGISTERED THE PRODUCT WITH THE FDA. THIS ITEM IS NOT SAFE FOR USE. THEY SUBMITTED CLASS LIST AS 888.5850. THIS IS NOT TRACTION EQUIPMENT AS DESCRIBED IN 888.5850.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTABLE NECK TRACTION * HST GIBBONS HEALTH PRODUCTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening