BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 4001903 · Received August 12, 2014

    Report

    Report Number
    9616091-2014-01474
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Report Date
    July 2, 2014
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE END USER STATES THE SEAT ON HER COMMODE IS CRACKED AND THE RAIL THE SEAT SITS ON IS PEELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478197 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX 9630-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other