BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL CHAIR/TRANSPORT CHAIR

    MDR report key: 4192973 · Received October 22, 2014

    Report

    Report Number
    9616091-2014-02220
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PER END USER THE BACK UPHOLSTERY IS TEARING AWAY FROM THE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671764 MECHANICAL CHAIR/TRANSPORT CHAIR 890.3100 IOR INVAMEX T4X22RDA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other