BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2052483 · Received March 15, 2011

    Report

    Report Number
    1525712-2011-00090
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    March 12, 2009
    Report Date
    March 11, 2011
    Manufacturer
    INVACARE
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER RECEIVED THE CHAIR AND DETERMINED THE BRAZE JOINT HAS BROKEN. THERE IS NO HISTORY TO SUGGEST A PRODUCT PROBLEM. THERE IS NO INJURY REPORTED. THIS APPEARS TO BE AN ISOLATED INCIDENT. MANUFACTURE CONTINUES TO INVESTIGATE.

    Description of Event or Problem · 1

    THE CONSUMER WAS BEING PUSHED IN HIS CHAIR WHEN THE CHAIR ALLEGEDLY COLLAPSED WHEN THE LEFT WELDMENT BROKE, CAUSING THE CONSUMER TO FALL TO THE FLOOR. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE WHDSX586DRL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR