BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 4132990 · Received October 1, 2014

    Report

    Report Number
    3007231105-2014-00063
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 10, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ILS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    END USER'S SPOUSE REPORTED THAT THE SEAT ON THE 9630-1 COMMODE HAS CRACKED ON THE RIGHT SIDE, HAS PINCHED HIS WIFE ON HER BOTTOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612874 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS UNKNOWN 9630-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other