BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3881995 · Received June 18, 2014

    Report

    Report Number
    9616091-2014-01044
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 19, 2014
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT THE FRAME ON A (B)(4) COMMODE BROKE. END USER FELL HITTING HER HEAD, USER IS SORE. NO ALLEGED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359261 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX 9650-4

    Patients

    Seq Age Sex Outcome Treatment
    1 70 Other