BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3230102 · Received July 16, 2013

    Report

    Report Number
    9616091-2013-01226
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    June 25, 2013
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USER STATES THE SEAT CRACKED ON BOTH ENDS OF THE FRONT WHERE IT SITS ON THE CROSSBAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329740 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX 9630-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other