BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HULKA FALLOPIAN TUBE CLIP

    MDR report key: 180699 · Received July 31, 1998

    Report

    Report Number
    180699
    Event Type
    Malfunction
    Date Received
    July 31, 1998
    Date of Event
    December 1, 1997
    Report Date
    July 2, 1998
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUME.
    Product Code
    HGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A LAPAROSCOPIC TUBAL OCCLUSION PROCEDURE WITH FALLOPIAN TUBE CLIPS WAS DONE ON 12/01/1997. IN JUNE 1998, THE PT BECAME PREGNANT. THE DOCTOR REPORTED THAT NO APPLICATION PROBLEMS WERE NOTED AT THE TIME CLIPS WERE APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HULKA FALLOPIAN TUBE CLIP Implant FALLOPIAN TUBE CLIP HGB RICHARD WOLF MEDICAL INSTRUME. 4986.09 1253

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR