BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3962661 · Received July 29, 2014

    Report

    Report Number
    9616091-2014-01325
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    June 24, 2014
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THE SEAT AND HARDWARE ARE TOO FLIMSY FOR MOST PEOPLE. HE STATES THE UNIT HE HAS NOW THE SEAT SHIFTS AND THE SEAT COMES OFF AT TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440810 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX 9650-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other