BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILSHIE CLIPS

    MDR report key: 8339596 · Received February 13, 2019

    Report

    Report Number
    MW5084070
    Event Type
    Injury
    Date Received
    February 13, 2019
    Date of Event
    April 23, 2016
    Report Date
    February 9, 2019
    Manufacturer
    COOPERSURGICAL, INC
    Product Code
    KNH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I UNDERWENT TUBAL LIGATION SURGERY ON (B)(6) 2016. I IMMEDIATELY REALIZED SOMETHING WAS NOT RIGHT THE DAY FOLLOWING SURGERY. I COULD NOT LAY MY LEGS FLAT WITHOUT A PILLOW UNDERNEATH DUE TO EXCRUCIATING PAIN . THIS HAS BEEN GOING ON AND OFF SINCE THE DATE. MY MENSTRUAL CYCLE IS PLAGUED WITH DEBILITATING PAIN WITH PROLONGED BLEEDING WITH CLOTS. I HAVE ALSO HAD PROBLEMS WITH BEING ESTROGEN DOMINANT. I HAVE BEEN DIAGNOSED WITH LOW VITAMIN D LEVELS. I HAVE BEEN DIAGNOSED WITH FIBROMYALGIA. I¿VE SUFFERED DEPRESSION WITH ANXIETY, WHICH HAS GOTTEN TO THE POINT I¿VE HAD TO RESORT TO COUNSELING & MEDICATION. I WAS GIVEN NO INFORMATION ON THE SIDE EFFECTS FROM THIS PROCEDURE OR THE POSSIBLE OUTCOMES WITH RISKS. I WAS GIVEN NO OTHER CHOICE FOR PERMANENT STERILIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127554 FILSHIE CLIPS LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE KNH COOPERSURGICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other