BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3103493 · Received May 9, 2013

    Report

    Report Number
    9616091-2013-00787
    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
    HI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE COMMODE SEAT WAS CRACKED. THIS ISSUE COULD CAUSE PRODUCT INSTABILITY AND THE POTENTIAL FOR THE SEAT TO CRACK IN HALF AND THE USER TO FALL OFF DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204323 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX 9630-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other