BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3200337 · Received July 1, 2013

    Report

    Report Number
    1525712-2013-05205
    Event Type
    Injury
    Date Received
    July 1, 2013
    Report Date
    June 7, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE JOYSTICK ON THE JOYSTICK ON HIS M51PMPURD POWERED WHEELCHAIR FELL APART. THE PATIENT THEN USED A PIN TO DRIVE THE CHAIR. WHILE DRIVING HIS POWERED WHEELCHAIR IN THE KITCHEN OF HIS HOME, HE LOST CONTROL OF THE CHAIR AND COLLIDED WITH HIS REFRIGERATOR. AS A RESULT, HE SUSTAINED A CUT ON HIS FOOT. FOLLOWING THE EVENT, THE PATIENT PRESENTED TO THE CLINIC WHERE HE WAS ALLEGEDLY DIAGNOSED WITH GANGRENE WHICH STEMMED FROM THE CUT HE SUSTAINED ON HIS FOOT. HIS LEG WAS, SUBSEQUENTLY, AMPUTATED BELOW THE KNEE AS A RESULT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300445 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M51PMPURD

    Patients

    Seq Age Sex Outcome Treatment
    1 52 Hospitalization| R| S