BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVACARE MANUAL WHEELCHAIR

    MDR report key: 1073665 · Received July 9, 2008

    Report

    Report Number
    1525712-2008-00057
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    May 27, 2008
    Report Date
    July 7, 2008
    Manufacturer
    INVAMEX - INVACRE MEXICO
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    MFR RECEIVED SUMMONS FROM ATTORNEY. THE WHEELCHAIR HAS BEEN IN USE SINCE 2005 WITH NO REPORTED INCIDENTS. THE CHAIR'S MAINTENANCE HISTORY IS UNK. CURRENT USER GUIDE COVERS PROPER MAINTENANCE. AS A CONSERVATIVE MEASURE, MDR FILED BASED ON INJURY.

    Description of Event or Problem · 1

    THE WHEEL LOCKS ALLEGEDLY DID NOT WORK PROPERLY TO HOLD THE CHAIR IN PLACE, CAUSING THE CONSUMER TO FALL TO THE FLOOR, RESULTING IN THE CONSUMER TO FRACTURE HER LEG IN TWO PLACES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE MANUAL WHEELCHAIR 890.3850 IOR INVAMEX - INVACRE MEXICO TRSX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention