BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3071993 · Received April 22, 2013

    Report

    Report Number
    9616091-2013-00681
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 27, 2013
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER DEALER, THE SEAT CRACKED ON THE RIGHT SIDE. ALLEGEDLY IT STARTED IN THE BACK AND WORKED ITS WAY ALL THE WAY DOWN THE SEAT TOWARD THE FRONT. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173019 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX 9610-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other