BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILSHIE

    MDR report key: 1032091 · Received September 19, 2007

    Report

    Report Number
    1216677-2007-00024
    Event Type
    Injury
    Date Received
    September 19, 2007
    Manufacturer
    FEMCARE-NIKOMED
    Product Code
    HGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER FOR THE FILSHIE CLIP IS AVM-851. THE LOT INFO IS NOT AVAILABLE. THE FILSHIE CLIPS ARE LOT CONTROLLED, HOWEVER THE FACILITY WHERE THE ORIGINAL APPLICATION OF THE FILSHIE CLIPS HAS NOT BEEN IDENTIFIED, NO DETERMINATION OF POSSIBLE LOT NUMBERS THAT MAY HAVE BEEN USED CANNOT BE MADE. FILSHIE CLIPS EFFECT STERILIZATION BY CAUSING NECROSIS AT THE SITE OF APPLICATION. SUBSEQUENTLY, THE CLIPS ARE HELD IN PLACE BY COVERING PERITONEUM. IF THIS PROCESS IS DELAYED, CLIP MIGRATION MAY RESULT. LOW GRADE INFLAMMATION MAY OCCUR IF DISPLACEMENT OCCURS. BOTH SILICONE AND TITANIUM HAVE BEEN WELL ESTABLISHED AS IMPLANT MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILSHIE CLIP, TUBAL OCCULSION HGB FEMCARE-NIKOMED AVM-851 *

    Patients

    Seq Age Sex Outcome Treatment
    1