BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILSHIE CLIP

    MDR report key: 2185051 · Received July 7, 2011

    Report

    Report Number
    1216677-2011-00012
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 29, 2011
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FILSHIE CLIP HAS NOT BEEN RETURNED TO COOPERSURGICAL INC. FOR EVAL. COOPERSURGICAL BECAME AWARE OF THIS EVENT ON (B)(6) 2011 VIA MAUDE EVENT REPORT (B)(4). NO REPORTED EVENTS OF SIMILAR ON RECORD. (B)(4).

    Description of Event or Problem · 1

    PT STATES SHE HAD FILSHIE CLIPS IMPLANTED ON (B)(6) 2007 AFTER THE BIRTH OF HER CHILD. IMMEDIATELY FOLLOWING THE PROCEDURE, SHE EXPERIENCED CRUSHING FATIGUE, MUSCLE AND JOINT ACHES AND ABDOMINAL PAIN. SHE CONTINUED TO LIVE WITH THE PAIN UNTIL A BLOOD CLOT FORMED IN (B)(6) 2009 AT THE LOCATION OF THE CLIP WHICH TRAVELED TO HER LUNG, CAUSING A PULMONARY EMBOLISM. SHE HAD BEEN ON AND OFF WARFARIN AND HAS CONSTANT PAIN IN BOTH OVARIES. SHE DID SOME RESEARCH AND ON (B)(6) 2011 SHE HAD THE FILSHIE CLIPS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILSHIE CLIP NONE HGB COOPERSURGICAL, INC. AVM-851

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention