BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3241849 · Received July 22, 2013

    Report

    Report Number
    9616091-2013-01270
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    July 3, 2013
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    UPON INITIAL CONTACT ON JULY THIRD, END-USER STATES THE SEAT HAS CRACKED THREE PREVIOUS TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340729 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX 9630-4

    Patients

    Seq Age Sex Outcome Treatment
    1 72 Other