BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPUTEE LEGREST FOR ETAC WHEELCHAIR CROSS

    MDR report key: 2846338 · Received November 12, 2012

    Report

    Report Number
    3008986539-2012-00073
    Event Type
    Injury
    Date Received
    November 12, 2012
    Date of Event
    May 14, 2012
    Report Date
    July 18, 2012
    Manufacturer
    ETAC SUPPLY CENTER AB
    Product Code
    INM
    PMA / PMN Number
    K914610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE THREAD OF THE SCREW, WITH WHICH THE AMPUTEE LEG REST¿S ANGLE ADJUSTMENT IS TIGHTENED, IS WORN. DUE TO THE WORN SCREW FULL CLAMPING FORCE COULD NOT BE REACHED AND THE AMPUTEE LEG REST SLID DOWN. ETAC WILL CHANGE THE DESIGN WHICH WILL PUT LESS STRESS ON THE SCREW AND IMPROVE CLAMPING FORCE.

    Description of Event or Problem · 1

    THE USER HAS THE LEFT LEG AMPUTATED AND IS DIAGNOSED WITH DEMENTIA. THE USER WAS SITTING IN THE WHEELCHAIR AND LEANED FORWARD, THE ADJUSTABLE AMPUTEE LEG REST SLID DOWN AND THE USER FELL OUT OF THE WHEELCHAIR. THE USER GOT A HIP FRACTURE DUE TO THE FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPUTEE LEGREST FOR ETAC WHEELCHAIR CROSS IOR. WHEELCHAIR, MECHANICAL INM ETAC SUPPLY CENTER AB 25516

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention