BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3083531 · Received April 29, 2013

    Report

    Report Number
    9616091-2013-00708
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 2, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED BY THE FACILITY STAFF THAT THE TRACER T4 MECHANICAL WHEELCHAIR FOOTPLATE WAS BROKEN. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184014 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX T424RDA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other