BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2012812 · Received March 1, 2011

    Report

    Report Number
    1525712-2011-00073
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    INVACARE
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER ALLEGEDLY WAS SITTING IN THEIR CHAIR WHEN THE FRAME BROKE, AND THE CONSUMER FELL REQUIRING SURGERY TO REPAIR A SCREW IN THEIR NECK. THE CHAIRS SERVICE AND MAINTENANCE HISTORY ARE UNKNOWN. MANUFACTURER IS WORKING WITH THE DEALER AND CONSUMER TO REPLACE THE CHAIR. MALFUNCTION NOT CONFIRMED. MANUFACTURER IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION.

    Description of Event or Problem · 1

    THE CONSUMER'S FATHER REPORTED THAT THE CONSUMER WAS SITTING IN THE CHAIR AT THE COMPUTER WHEN THE FRAME ALLEGEDLY BROKE ON BOTH SIDES, CAUSING THE CONSUMER TO FALL. THE FALL ALLEGEDLY CAUSED DAMAGE TO A SCREW IN THE CONSUMERS NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE T6A

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR