BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 4131161 · Received October 1, 2014

    Report

    Report Number
    9616091-2014-02038
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 18, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ILS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER'S WIFE REPORTED THAT THE SEAT ON HER HUSBAND'S 9630-4 COMMODE IS CRACKED; HAS PINCHED HIM A FEW TIMES. NO ALLEGED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612674 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS UNKNOWN 9630-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other