BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVACARE POWER WHEELCHAIR

    MDR report key: 513627 · Received February 26, 2004

    Report

    Report Number
    1525712-2004-00025
    Event Type
    Injury
    Date Received
    February 26, 2004
    Date of Event
    January 30, 2004
    Report Date
    February 26, 2004
    Manufacturer
    INVACARE CORPORATION
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE CONSUMERS FAMILY MEMBER ALLEGES THE CHAIR WENT "BERSERK" AND PT FELL OUT OF THE CHAIR BECAUSE IT ALLEGEDLY KEPT SPINNING. THIS ALLEGEDLY RESULTED IN TWO LOOSE TEETH, BLACK EYE, CUT ON LIP, AND A SWOLLEN KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE POWER WHEELCHAIR 890.3860 ITI INVACARE CORPORATION TDX5 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention