BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALTRAC ANASTOMOSIS RING

    MDR report key: 19110 · Received January 24, 1995

    Report

    Report Number
    MW1004848
    Event Type
    Injury
    Date Received
    January 24, 1995
    Date of Event
    January 1, 1995
    Report Date
    January 23, 1995
    Manufacturer
    DAVIS AND GECK, INC.
    Product Code
    LNN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICES WERE IMPLANTED ON 1/16 AND 1/17/95 IN TWO PTS, AGED 35 AND 42. THE DEVICE IMPLANTED ON 1/6/95, WAS DISCOVERED TO HAVE BEEN EXPELLED ON 1/16/95. THE DEVICE IMPLANTED ON 1/9/95, WAS DISCOVERED TO BE LEAKING ON 1/17/95. BOTH PTS HAD TO GO BACK TO SURGERY. AT THIS TIME, THE RPTR DOES NOT KNOW WHICH SIZE WAS IMPLANTED IN WHICH PT. (ALSO SEE 1004849.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALTRAC ANASTOMOSIS RING Implant LNN DAVIS AND GECK, INC. 886270

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention