BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 4132844 · Received October 1, 2014

    Report

    Report Number
    9616091-2014-02050
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 12, 2014
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9650-4 COMMODE WILL NOT LOCK ON THE FRAME OF THE TOILET. THIS IS AN OUT OF BOX ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612761 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX 9650-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other