BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3024281 · Received March 27, 2013

    Report

    Report Number
    9616091-2013-00521
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    March 1, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    PER PROVIDER THE HAS A BROKEN WELD AT THE BOTTOM IN THE REAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125532 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX T4X24RDA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other