BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4151961 · Received October 8, 2014

    Report

    Report Number
    3008262382-2014-01484
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 22, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES THE SEAT BELT HAS A TEAR IN IT FROM THE END USER RUNNING IT OVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633247 POWERED WHEELCHAIR 890.3860 ITI INVACARE REHABILITATION EQUIP M41SR20R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other