BEUDAMED
    FDA Adverse Event Other Summary report: N

    TENET LIMB POSITIONER

    MDR report key: 3035489 · Received October 31, 2006

    Report

    Report Number
    9681741-2006-00001
    Event Type
    Other
    Date Received
    October 31, 2006
    Date of Event
    October 20, 2006
    Report Date
    October 24, 2006
    Manufacturer
    TENET MEDICAL ENGINEERING
    Product Code
    CCX
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE DO NOT BELIEVE THIS TO BE A REPORTABLE EVENT. NO MECHANICAL DEFECT FOUND ON PRODUCT. PRODUCT WAS IN OBVIOUS STATE OF DISREPAIR.

    Description of Event or Problem · 1

    CYLINDER ON SPIDER CAME OFF WHEN NITROGEN WAS ATTACHED AND TURNED ON. THE CYLINDER HIT A (B)(6) HOSPITAL EMPLOYEE ON THE LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENET LIMB POSITIONER SPIDER CCX TENET MEDICAL ENGINEERING 7210569

    Patients

    Seq Age Sex Outcome Treatment
    1