BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HULKA FALLOPIAN TUBE CLIP

    MDR report key: 278584 · Received May 17, 2000

    Report

    Report Number
    1418479-2000-00036
    Event Type
    Injury
    Date Received
    May 17, 2000
    Date of Event
    April 18, 2000
    Report Date
    April 18, 2000
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    HGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A FALLOPIAN TUBE CLIP WAS BEING APPLIED WHEN THE METAL SPRING COMPONENT REPORTEDLY PUSHED THE PLASTIC JAWS AWAY, INSTEAD OF SLIDING OVER IT. THE CLIP THEN CAME APART AND FELL INTO THE ABDOMEN. BOTH COMPONENT PARTS WERE RETRIEVED AFTER A SECOND INCISION WAS MADE. ANOTHER CLIP WAS APPLIED WITH NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HULKA FALLOPIAN TUBE CLIP FALLOPIAN TUBE CLIP HGB RICHARD WOLF MEDICAL INSTRUMENTS CORP. 4986.09 1272

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization