BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILSHIE

    MDR report key: 1082592 · Received July 23, 2008

    Report

    Report Number
    1216677-2008-00022
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 27, 2008
    Report Date
    July 23, 2008
    Manufacturer
    FEMCARE-NIKOMED
    Product Code
    HGB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY PURCHASED THE APPLICATOR IN 2006. FEMCARE-NIKOMED, THE MFR, RECOMMENDS THE APPLICATOR IS SERVICED EVERY 100 USES OR YEARLY WHICH EVER COMES FIRST. THE APPLICATOR HAS NOT BEEN SERVICED SINCE PURCHASED. AS OF THIS REPORT, THE USER FACILITY HAS NOT YET RETURNED THE APPLICATOR. THIS REPORT WILL BE SUPPLEMENTED AS APPROPRIATE UPON RECEIPT OF THE APPLICATOR AND THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING A TUBAL LIGATION, THE HINGE OF THE FILSHIE APPLICATOR BROKE WHILE IN THE PATIENT. A SMALL PIECE OF THE HINGE WAS NOT FOUND. THE TIP WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILSHIE CLIP, TUBAL OCCULSION HGB FEMCARE-NIKOMED AVM-856

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention