BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4103244 · Received September 19, 2014

    Report

    Report Number
    9616091-2014-01936
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 29, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE END USER STATES THE BACK REST IS NOT TIGHT ON THE CHAIR. THE END USER STATES THE ARM RESTS ARE WOBBLING. THE END USER STATES THAT THE CHAIR WAS ORDERED WITH A BACK BRAKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581656 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TRSX5RC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other