BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 4191985 · Received October 22, 2014

    Report

    Report Number
    9616091-2014-02214
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Report Date
    October 21, 2014
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER REPORTED THAT THE SEAT ON HER 9630-4 COMMODE HAS CRACKED AND PINCHED HER REAR END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672920 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX 9630-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other