BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FALOPE-RING TUBAL OCCLUSION BAND

    MDR report key: 29150 · Received December 28, 1995

    Report

    Report Number
    MW1008016
    Event Type
    Malfunction
    Date Received
    December 28, 1995
    Date of Event
    November 21, 1995
    Report Date
    December 11, 1995
    Manufacturer
    CABOT MEDICAL PRODUCTS CORP.
    Product Code
    HFY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS SCHEDULED FOR A LAPAROSCOPIC TUBAL BANDING. AT LEAST SIX PAIRS OF TUBAL OCCLUSION BANDS BROKE DURING THE PROCEDURE. THE PROCEDURE WAS CONVERTED TO A MINILAPAROTOMY FOR PURPOSES OF TUBAL LIGATION. THE SALES REPRESENTATIVE WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FALOPE-RING TUBAL OCCLUSION BAND FALOPE-RING HFY CABOT MEDICAL PRODUCTS CORP. 000719 1410005

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other