BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4242814 · Received November 11, 2014

    Report

    Report Number
    1525712-2014-07808
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 22, 2014
    Report Date
    September 9, 2015
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RETURNED FOR EVALUATION. THE RETURN FIELDS IN ORACLE STATE: FRAME; BROKEN/CRACKED TUBING AT CENTER HOLE BOTH SIDES. COMPLAINT WAS CONFIRMED. THE UNDERLYING CAUSE COULD NOT BE DETERMINED AFTER REVIEWING THE DOCUMENTATION IN THIS INVESTIGATION.

    Description of Event or Problem · 1

    DEALER ALLEGES THE METAL BAR WHERE SEAT CONNECTS IS CRACKED ON A (B)(4) WHEELCHAIR.

    Description of Event or Problem · 1

    PRODUCT WAS RETURNED FOR EVALUATION. THE RETURN FIELDS IN ORACLE STATE: FRAME; BROKEN/CRACKED TUBING AT CENTER HOLE BOTH SIDES. DEALER ALLEGES THE METAL BAR WHERE SEAT CONNECTS IS CRACKED ON A CT7A WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725188 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET CT7A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other