BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR 5000

    MDR report key: 564028 · Received November 21, 2004

    Report

    Report Number
    MW1034112
    Event Type
    Injury
    Date Received
    November 21, 2004
    Date of Event
    March 29, 2001
    Report Date
    November 21, 2004
    Manufacturer
    R & R INDUSTRIES, INC.
    Product Code
    IQE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    EMPLOYER SENT EMPLOYEE OUT ON A DELIVERY EMPLOYER SAID (IMPLIED BACK SUPPORT BELT IS SAFETY EQUIPMENT) AND MANDATORY TO WEAR. DEVICE COLLAPSED ON EMPLOYEE WHEN LIFTING TWO CASES OF ANTIFREEZE THAT WERE DOUBLE TAPED TOGETHER FOR SHIPPING BACK SUPPORT BELT FAILED CAME LOOSE DID NOT STABLIZE EMPLOYER AND MANUFACTURER FAILED TO WARN OF IMPENDING DANGERS OF SUCH DEVICE. EMPLOYEE RECEIVED GREVIOUS INJURY TO LOWER BACK AT L3-L4 L4-L5 L5 -S1 WHICH GAVE A PERMANENT INJURY. [NOTE** MEDICAL DEVICE IS SOLD THROUGH A INDUSTRIAL SAFETY CATALOG] EMPLOYER KNEW ABOUT DEVICE AS NOT BEING SAFETY EQUIPMENT. EMPLOYER IMPLIED BACK SUPPORT BELT AS BEING SAFETY EQUIPMENT AND MANDATORY TO WEAR PRODUCT IS UNTRACEABLE AS THEIR IS NO SKEW ON PRODUCT OR MODEL# ON SUCH DEVICE OR CATALOG# ON SUCH DEVICE NO EXPIRATION ON SUCH DEVICE. EMPLOYER AND MANUFACTURER FAILED TO WARN OF IMPENDING DANGER OF SUCH DEVICE. EMPLOYER AND MANUFACTURER FAILED TO LABEL SUCH DEVICE AS MEDICAL EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR 5000 LUMBAR ABDOMINAL BACK SUPPORT BELT IQE R & R INDUSTRIES, INC. UNK UNTRACEABLE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| S