BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3103490 · Received May 9, 2013

    Report

    Report Number
    9616091-2013-00785
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 15, 2013
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT AN UNKNOWN INVAMEX COMMODE SEAT WAS CRACKING AT THE SEAM. THIS ISSUE COULD CAUSE INJURY TO THE USER OR THEY COULD FALL WHEN USING THE COMMODE SHOULD THE SEAT CRACK IN HALF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203961 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other