BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILSHIE CLIP

    MDR report key: 10157740 · Received June 15, 2020

    Report

    Report Number
    MW5095000
    Event Type
    Injury
    Date Received
    June 15, 2020
    Date of Event
    June 11, 2020
    Report Date
    June 11, 2020
    Manufacturer
    COOPER SURGICAL INC. / FEMCARE LTD.
    Product Code
    KNH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED A FILSHIE CLIP IN 2006 AND HAVE HAD PROBLEMS WITH UNEXPLAINED PAIN AND MAJOR ISSUES WITH SCAR TISSUE BUILD UP IN MY ABDOMEN. IT SHUT DOWN MY GALL BLADDER AND CAUSED ME TO LOST BOTH OVARIES. MY DOCTOR SAID HE'S NEVER SEEN SO MUCH SCAR TISSUE WHEN THE LAST OVARY WAS REMOVED. THE CLIP CONSISTENTLY SHOWS UP ON XRAYS AS TRAVELLING THROUGH MY BODY AND I HAVE HAD PAIN AND HOSPITAL ADMISSIONS SEVERAL TIMES, UNEXPLAINED SOURCE. I ABSOLUTELY BELIEVE IT'S THE CLIP FLOATING FREELY THROUGH MY BODY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616648 FILSHIE CLIP LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE KNH COOPER SURGICAL INC. / FEMCARE LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| S