BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3133124 · Received May 29, 2013

    Report

    Report Number
    9616091-2013-00902
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 2, 2013
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    INJURY SUSTAINED BY THE USER DUE TO A 9630-4 COMMODE WHOSE FRAME BROKE, CAUSING THE USER TO BE PINCHED BY THE DEVICE. NO MEDICAL INTERVENTION WAS RECEIVED AT THE TIME OF THE INCIDENT. WILL FOLLOW UP IF MORE INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236089 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX 9630-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other