BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3250887 · Received July 29, 2013

    Report

    Report Number
    9616091-2013-01340
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 10, 2013
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATED THAT ONE OF THE BARS HOLDING THE SEAT ONTO THE FRAME BECAME LOOSE AND BECAME DISCONNECTED FROM THE COMMODE, MAKING IT NOT FIT FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353909 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX 9630-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other