BEUDAMED
    FDA Adverse Event Other Summary report: N

    FILSHIE CLIP APPLICATOR

    MDR report key: 408495 · Received July 31, 2002

    Report

    Report Number
    MW1025726
    Event Type
    Other
    Date Received
    July 31, 2002
    Date of Event
    June 18, 2002
    Report Date
    July 31, 2002
    Manufacturer
    AVALON MEDICAL CORP
    Product Code
    HGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A POST-CESAREAN TUBAL LIGATION THE FILSHIE CLIP APPLICATOR STOPPED FUNCTIONING PROPERLY. INSPECTION OF THE INSTRUMENT AFTER THE PROCEDURE REVEALED THAT A SMALL METAL PIECE HAD BROKEN OFF. X-RAYS OF THE PT SHOWED THAT THE FRAGMENT WAS STILL INSIDE OF THEM. THE PT UNDERWENT AN ADD'L PROCEDURE TO RETRIEVE METAL FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILSHIE CLIP APPLICATOR INSTRUMENT-SURGICAL HGB AVALON MEDICAL CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other