BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE ENTREE II VALVE/REDUCER

    MDR report key: 862012 · Received June 7, 2007

    Report

    Report Number
    1320894-2007-00103
    Event Type
    Malfunction
    Date Received
    June 7, 2007
    Date of Event
    April 30, 2007
    Report Date
    June 7, 2007
    Manufacturer
    CONMED CORP.
    Product Code
    FBM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE INVESTIGATION HAS BEEN COMPLETED, I WILL SUBMIT A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PIECES OF SEAL FELL IN ABDOMEN OF PT". NO APPARENT INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE ENTREE II VALVE/REDUCER ENDO VALVE REDUCER FBM CONMED CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR