BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4121703 · Received September 26, 2014

    Report

    Report Number
    9616091-2014-01996
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER DEALER PATIENT IS COMPLAINING BOTH SEAT AND BACK UPH STRETCHED AND SAGGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602265 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX T422RFA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other