BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILSHIE CLIPS

    MDR report key: 21291365 · Received February 3, 2025

    Report

    Report Number
    MW5165498
    Event Type
    Injury
    Date Received
    February 3, 2025
    Date of Event
    November 23, 2022
    Report Date
    January 29, 2025
    Manufacturer
    FEMCARE LTD.
    Product Code
    KNH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 3/6/2025 FOR REPORT NUMBER MW5165498 TO CHANGE MANUFACTURER'S NAME.

    Description of Event or Problem · 0

    PATIENT CALLED TO REPORT AN ADVERSE EVENT INVOLVING FILSHIE CLIPS SHE HAD IMPLANTED IN 2012. PATIENT STATED IN 2022 SHE FOUND THAT THE CLIPS HAD MIGRATED AND IN (B)(6) OF 2023 SHE HAD 3 SURGERIES TRYING TO REMOVE THE CLIPS HOWEVER ONLY 1 WAS ABLE TO BE REMOVED. PATIENT STATED THE CLIP THAT IS STILL IMPLANTED WAS SEEN ON X-RAY TRAVELING UP TOWARDS HER CHEST AND IS CONSIDERED LIFE-THREATENING AT THIS TIME. PATIENT STATED SHE¿S NERVOUS TO HAVE ANOTHER SURGERY IN THE UNITED STATES AND IS SEEKING REMOVAL SURGERY OVERSEAS. PATIENT STATED SHE CANNOT WORK DUE TO THIS DEVICE COMPLICATION. I AM CURRENTLY EXPECTING MY SURGERY SOON OVERSEAS TO REMOVE THIS PRODUCT OF A FILSHIE CLIP THAT IS MIGRATING TOWARDS MY LUNGS. I WOULD APPRECIATE A CALL OR EMAIL ON WHAT TO DO NEXT TO GET THIS REMOVED IMMEDIATELY. WHAT KIND OF SYMPTOMS, PAIN OR DISCOMFORT DID YOU EXPERIENCE? EXTREME DISCOMFORT DURING MENSTRUATION, PAINFUL SHARP STABBING PAIN DURING SEX, MENTAL ILLNESSES, SUICIDAL TENDENCIES, DEPRESSION, SHARP PAINS, DIZZINESS, FATIGUE, STIFFNESS, NAUSEA, STIFFNESS IN MY HIPS, LEGS, AND GROIN, INABILITY TO PERFORM NORMAL DAILY ACTIVITIES, PAIN WHILE URINATING, PAINFUL AND IRREGULAR PERIODS, INABILITY TO WALK, SIT OR STAND, IMMOBILIZED FOR LONG PERIODS OF TIME, PAIN AROUND ANUS AREAS. DID YOU CONSULT WITH A HEALTH CARE PROVIDER TO DISCUSS THE SYMPTOMS, PAIN AND DISCOMFORT YOU WERE EXPERIENCING? IF SO, PLEASE DESCRIBE: YES, SINCE THE FIRST YEAR I GOT THEM, I WAS EXPERIENCING EXTREME PAIN IN PERFORMANCE OF EVERYDAY TASKS. I CONTINUED TO GO TO THE DOCTORS ABOUT IT BUT ALWAYS BEEN DISMISSED AS "PERIOD CRAMPS" ETC. AS OF THE LAST FEW YEARS IT GOT MUCH WORSE, I STILL GOT DISMISSED AND GOTTEN "NORMAL" RESULTS FROM THE DOCTORS THAT I WAS FINE. PAGE 1 OF 5. AS OF THE PAST FEW MONTHS IT'S BEEN THE WORSE, I'VE EVER EXPERIENCED. I'VE HAD MANY YEARS OF INPATIENT HOSPITALIZATION, SUICIDAL ATTEMPTS AND MAJOR DOCTORS EXPERIENCE THAT HAS DIAGNOSED MAJOR MENTAL PROBLEMS AND HOSPITAL VISITS TO ER FOR EXTREME PELVIC PAIN, POSSIBLE CANCEROUS CELLS FROM PELVIC INFECTIONS. ALL OF THE HOSPITALS HAVE MY MEDICAL RECORDS, WILL BE MORE THAN HAPPY TO RELEASE TO ATTORNEYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2116509 FILSHIE CLIPS LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE KNH FEMCARE LTD. AVM851

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Life Threatening