BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILSHIE CLIPS

    MDR report key: 2113333 · Received May 27, 2011

    Report

    Report Number
    MW5020821
    Event Type
    Injury
    Date Received
    May 27, 2011
    Date of Event
    December 25, 2009
    Report Date
    May 27, 2011
    Manufacturer
    THE COOPER COMPANIES
    Product Code
    KNH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM THE PT! I HAD FILSHIE CLIPS PLACED IN ME IN (B)(6) 2007 AFTER GIVING BIRTH TO MY THIRD CHILD. IMMEDIATELY FOLLOWING THIS PROCEDURE, I EXPERIENCED A HOST OF SYMPTOMS, INCLUDING CRUSHING FATIGUE, MUSCLE AND JOINT ACHES, AND MORE CRITICALLY, ABDOMINAL PAIN. I CONTINUED TO LIVE AND EXERCISE THROUGH THE PAIN UNTIL (B)(6) 2009, I ACTUALLY DEVELOPED A BLOOD CLOT AT THE LOCATION OF THE CLIP, WHICH TRAVELED TO MY RIGHT LUNG (PULMONARY EMBOLISM CONFIRMED BY CT). I HAVE BEEN ON AND OFF WARFARIN SINCE THEN, WITH CONSISTENT PAIN AT BOTH OVARIES. I FINALLY EDUCATED MYSELF ABOUT THESE DANGEROUS DEVICES, AND LAST FRIDAY ((B)(6) 2011), I HAD THEM SURGICALLY REMOVED AND MY REPRODUCTIVE ORGANS RESTORED. THESE CLIPS SHOULD BE PULLED OFF THE MARKET!

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILSHIE CLIPS STERILIZATION CLAMPS KNH THE COOPER COMPANIES 12345
    2 FILSHIE CLIPS STERILIZATION CLAMPS KNH THE COOPER COMPANIES 12345

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| L| R