BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4220253 · Received November 3, 2014

    Report

    Report Number
    1525712-2014-07540
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 28, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT THE END USER REPORTED THAT HER M51P POWER CHAIR IS NOT GOING WHERE IT IS BEING GUIDED, CAUSED HER TO RUN INTO A CABINET, JAMMED HER LEG AGAINST THE CABINET. THE DIAGNOSIS FROM THE HOSPITAL WAS A BRUISED BONE IN HER LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702085 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M51P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other