BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2912611 · Received January 13, 2013

    Report

    Report Number
    1525712-2013-00354
    Event Type
    Malfunction
    Date Received
    January 13, 2013
    Date of Event
    December 14, 2012
    Report Date
    January 13, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). THE DEALER REPORTED THAT THE TDXSP-MCG POWR WHEELCHAIR CASTER SILVER HUB WAS CRACKED, CAUSING TIRE TO DISMOUNT. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19444 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other