BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3944776 · Received July 18, 2014

    Report

    Report Number
    9616091-2014-01235
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    June 10, 2014
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9669 COMMODE FRAME IS BENT AND BOLT IS SHEARED OFF OF ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422859 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX 9669

    Patients

    Seq Age Sex Outcome Treatment
    1 Other