BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2981851 · Received February 27, 2013

    Report

    Report Number
    1525712-2013-01486
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 31, 2013
    Manufacturer
    UNKNOWN
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED BY THE CONSUMER'S LEGAL REPRESENTATIVE THAT ALLEGEDLY ONE OF THE RIMS ON THE T4 CUSTOM MECHANICAL WHEELCHAIR WAS BROKEN. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83946 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR UNKNOWN T4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other