BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FALLOPIAN RING APPLICATOR

    MDR report key: 33105 · Received May 22, 1996

    Report

    Report Number
    MW1009141
    Event Type
    Injury
    Date Received
    May 22, 1996
    Date of Event
    April 18, 1996
    Report Date
    May 13, 1996
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    KNH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT SCHEDULED FOR BILATERAL TUBAL OCCLUSION WITH FALLOPIAN RING. DURING SURGERY THE FALLOPIAN RING APPLICATOR FRACTURED THE TUBE AND CAUTERIZATION WAS REQUIRED FOR BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FALLOPIAN RING APPLICATOR FALLOPIAN RING APPLICATOR KNH RICHARD WOLF MEDICAL INSTRUMENTS CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention