BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3092847 · Received May 3, 2013

    Report

    Report Number
    1525712-2013-03502
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 9, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER END USER LEFT ARM PAD IS CRACKING. CONSUMER ALLEGES HE TOLD DEALER AND DEALER ORDERED WRONG PART, NEVER CAME BACK TO FIX. CONSUMER STATES ARM IS HURTING DUE TO ARM PAD CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194221 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET 3GAR

    Patients

    Seq Age Sex Outcome Treatment
    1 64 Other