BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 478543 · Received July 28, 2003

    Report

    Report Number
    478543
    Event Type
    Malfunction
    Date Received
    July 28, 2003
    Date of Event
    January 1, 2003
    Report Date
    February 1, 2003
    Manufacturer
    *
    Product Code
    HFJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A FALLOPIAN RING WAS APPLIED TO THE FALLOPIAN TUBE. THE RING LOCKED IN PLACE AND WOULDN'T OPEN TO RELEASE THE FALLOPIAN TUBE. SCISSORS WERE REQUIRED TO OPEN THE RING AND A SECOND INSTRUMENT WAS REQUIRED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PT AND NO BLEEDING OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * FALLOPIAN RING HFJ * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other ANESTHESIA.