BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 716629 · Received May 2, 2006

    Report

    Report Number
    MW1038953
    Event Type
    Malfunction
    Date Received
    May 2, 2006
    Date of Event
    March 24, 2006
    Report Date
    April 18, 2006
    Manufacturer
    CODMAN
    Product Code
    HDQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A ULTRASOUND GUIDED CERVICAL DILATATION HYSTEROSCOPY AND D&C POLYPECTOMY. A HANK UTERINE DILATOR GAUGE 11/12 WAS USED DURING THE PROCEDURE. FIVE DAYS FOLLOWING PROCEDURE, PT REPORTED SHE REMOVED 3 METAL PIECES FROM HER VAGINA. METAL PIECES FORMED A SMALL RING. GYN EQUIPMENT EXAMIMED. A DILATOR SIZE 11/12 WAS FOUND TO BE WITHOUT O RING PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * DILATOR SIZE 11/12 HDQ CODMAN * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR