BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3133259 · Received May 29, 2013

    Report

    Report Number
    9616091-2013-00905
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    December 12, 2012
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT WAS NOT GIVEN TO REGULATORY AFFAIRS FROM CUSTOMER SERVICE FOR PROCESSING UNTIL ((B)(4) 2013). POTENTIAL FOR PINCH OR FALL INJURY ASSOCIATED WITH A BROKEN SEAT ON A 9630-4 COMMODE.

    Description of Event or Problem · 1

    PROVIDER STATES THE SEAT BROKE ON THE COMMODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236608 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX 9630-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other