BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 4012259 · Received August 15, 2014

    Report

    Report Number
    9616091-2014-01525
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Report Date
    July 11, 2014
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9669 COMMODE SEAT CRACKED DOWN CENTER. END USER HAS TAPE ON IT TO PREVENT PINCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490083 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX 9669

    Patients

    Seq Age Sex Outcome Treatment
    1 69 Other