BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHEELCHAIR ACCESSORY

    MDR report key: 2170476 · Received July 21, 2011

    Report

    Report Number
    1525712-2011-00363
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 20, 2011
    Report Date
    July 19, 2011
    Manufacturer
    UNKNOWN
    Product Code
    FSA
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVACARE LABELS STATES INVACARE SLINGS SHOULD BE USED ON INVACARE LIFTS. THE MANUFACTURER OF THE LIFT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CONSUMER WAS BEING LIFTED WITH AN UNKNOWN LIFT AND INVACARE SLING WHEN 2 STRAPS ON THE SLING ALLEGEDLY BROKE, CAUSING THE CONSUMER TO FALL TO THE FLOOR AND HIT HIS HEAD ON A CUSHIONED CHAIR. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHEELCHAIR ACCESSORY 890.3910 FSA UNKNOWN R112

    Patients

    Seq Age Sex Outcome Treatment
    1