BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FALOPE-RING BAND

    MDR report key: 30081 · Received January 12, 1996

    Report

    Report Number
    30081
    Event Type
    Malfunction
    Date Received
    January 12, 1996
    Date of Event
    November 21, 1995
    Report Date
    December 11, 1995
    Manufacturer
    CABOT MEDICAL CORP.
    Product Code
    KNH
    Product Problem
    Yes
    Report Source
    User Facility 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 PAIR OF TUBAL OCCLUSION BANDS BROKE DURING PROCEDURE. WAS CONVERTED TO A MINILAPAROTOMY FOR PURPOSES OF TUBAL LIGATION. THE SALES REPRESENTATION WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FALOPE-RING BAND BAND TUBAL OCCLUSION KNH CABOT MEDICAL CORP. 000719-250 1410005

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other