BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILSHIE CLIP

    MDR report key: 8866365 · Received August 5, 2019

    Report

    Report Number
    MW5088837
    Event Type
    Injury
    Date Received
    August 5, 2019
    Date of Event
    January 25, 2015
    Report Date
    August 4, 2019
    Manufacturer
    COOPERSURGICAL, INC/FEMCARE LTD.
    Product Code
    KNH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RIGHT AFTER SURGERY FOR TUBES BEING TIED WITH FILSHIE CLIPS. I HAD AN ONGOING INFECTION THAT LASTED MONTHS AFTER THE TUBAL. STABBINGS PAINS, OVARIAN CYST THAT I NEVER HAD PRIOR TO GETTING TUBES TIED, WEIGHT GAIN, HIVES ETC. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656029 FILSHIE CLIP LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE KNH COOPERSURGICAL, INC/FEMCARE LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization