BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3073573 · Received April 23, 2013

    Report

    Report Number
    9616091-2013-00687
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 26, 2013
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATES SEAT IS CRACKED ON BOTH SIDES. NEEDS MORE SUPPORTS, GUSSETS AS HE SAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175346 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX 9630-1

    Patients

    Seq Age Sex Outcome Treatment
    1 84 Other