BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILSHIE CLIPS

    MDR report key: 11348453 · Received February 18, 2021

    Report

    Report Number
    MW5099493
    Event Type
    Injury
    Date Received
    February 18, 2021
    Date of Event
    July 1, 2019
    Report Date
    February 16, 2021
    Manufacturer
    FEMCARE-NIKOMED LTD/ COOPERSURGICAL, INC.
    Product Code
    HHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A TUBAL LIGATION WITH THE FILSHIE CLIPS PLACED. I WENT FROM BEING A TYPICAL MOTHER BEING ABLE TO TAKE CARE OF MY KIDS AND LIFE. TO NOT BEING ABLE TO LIVE BECAUSE OF CONSISTENTLY BEING IN PAIN, HAVING NO ENERGY AND JUST OVER ALL MISERABLE. I SPENT 18 MONTHS THIS WAY, MOST OF WHAT HURT ME WAS THE CONSISTENT PAIN THAT GOT WORSE DURING MY MENSTRUAL CYCLE EVERY MONTH. I WENT FROM HAVING ABSOLUTELY MINIMAL MENSTRUAL PAIN TO COLLAPSING ON THE FLOOR IN TEARS AND THROWING UP BECAUSE THE PAIN WAS SO BAD. I WAS SO DEPRESSED FROM HAVING THESE CLAMPS IN ME I HATED BEING ALIVE. I COULD BARELY HAVE THE ENERGY TO TAKE CARE OF MY KIDS ON A NORMAL EVERY DAY BASIS I COULDN'T TAKE CARE OF MY HOME. MY HAIR STARTED FALLING OUT, I COULDN'T LOSE ANY BABY WEIGHT. I WAS FINALLY DIAGNOSED WITH POST TUBAL LIGATION SYNDROME 14 MONTHS AFTER I HAD A TUBAL WITH THESE CLIPS PLACED. IT WASN'T TILL THE CLAMPS WHERE OUT THAT I GOT BACK EVERYTHING I HAD LOST AND FELT 100% BACK TO MYSELF. EPILEPSY, ASTHMA, CLOT TOO FAST, POLYCYSTIC OVARIAN SYNDROME, KIDNEY DISEASE. FDA SAFETY REPORT ID #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238673 FILSHIE CLIPS LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLU HHS FEMCARE-NIKOMED LTD/ COOPERSURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Disability