BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLIP TUBAL LIGATION FILSHIE

    MDR report key: 13019038 · Received December 15, 2021

    Report

    Report Number
    MW5106083
    Event Type
    Injury
    Date Received
    December 15, 2021
    Date of Event
    August 15, 2021
    Report Date
    December 13, 2021
    Manufacturer
    COOPER SURGICAL INC. / FEMCARE LTD.
    Product Code
    KNH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD TUBAL LIGATION CLIPS (FILSHIES) IMPLANTED AT THE BIRTH OF MY THIRD CHILD ON (B)(6) 2015. I DID NOT KNOW THEY IMPLANTED ANYTHING IN ME. I BELIEVED THEY WERE JUST TYING THEM. IMMEDIATELY FOLLOWING MY PERIODS BECAME VERY HEAVY AND PAINFUL. THIS WAS NEVER AN ISSUE BEFORE. IN 2016 I WAS PRESCRIBED AND STILL TAKE BIRTH CONTROL PILLS TO NOT HAVE PERIODS. NOT HAVING TO TAKE THE PILL HAD BEEN MY PRIMARY OBJECTION IN GETTING MY TUBES TIED TO BEGIN WITH. THEN IN (B)(6) OF 2021, I BEGAN HAVING SEVERE CHEST, UPPER BACK AND LEFT ARM PAIN. IN (B)(6) OF 2021 I HAD A SERIES OF XRAYS AND A CT SCAN THAT SHOWED THAT MY LEFT CLIP HAD MIGRATED TO MY UPPER LEFT QUADRANT. IT IS SITTING IN OR AROUND MY SPLEEN AND NOW HAS TO BE REMOVED. ALL OF THIS HAS COME AT COST TO MY QUALITY OF LIFE AND POCKET BOOK. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1913159 CLIP TUBAL LIGATION FILSHIE LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE KNH COOPER SURGICAL INC. / FEMCARE LTD. AVM-851

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Hospitalization SPRINTEC (BIRTH CONTROL)