BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNMARK OVER-DOOR HEAD TRACTION SET

    MDR report key: 356508 · Received October 16, 2001

    Report

    Report Number
    MW1023135
    Event Type
    Injury
    Date Received
    October 16, 2001
    Date of Event
    October 16, 2001
    Report Date
    October 16, 2001
    Manufacturer
    SUNMARK HOME HEALTH CARE CO MCKESSON CORP
    Product Code
    HST
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TODAY RPTR PURCHASED A SUNMARK HOME HEALTH CARE CO MCKESSON COPR OVER DOOR HEAD TRACTION SET. PROD NO 456. ECON NO 186-0584. RPTR'S FIRST USE OF THIS PRODUCT, USED AS ORDERED BY PHYSICIAN, DIRECTED IN ITS USE BY A PHYSICAL THERAPIST, AND ASSEMBLED AS DIRECTED, CUT THROUGH A HALTER LOOP. THE SPREADER BAR IS STAMPED OUT AND HAS SHARP EDGES. AS A MEDICAL DEVICE THIS IS VERY POORLY MADE AND SHOULD BE RECALLED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46292 SUNMARK OVER-DOOR HEAD TRACTION SET CERVICAL TRACTION HST SUNMARK HOME HEALTH CARE CO MCKESSON CORP 459 *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention| S