BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDGYN FLEXIBLE CURETTE 11MM REF. NO. 022011

    MDR report key: 593122 · Received April 15, 2005

    Report

    Report Number
    MW1035235
    Event Type
    Malfunction
    Date Received
    April 15, 2005
    Date of Event
    August 27, 2004
    Report Date
    April 7, 2005
    Manufacturer
    MEDGYN PRODUCTS, INC.
    Product Code
    HCY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN ASPIRATION ABORTION PROCEDURE USING 11 MM FLEXIBLE CANNULA THE CANNULA WAS UNABLE TO BE WITHDRAWN AND REMOVED FROM WITHIN THE UTERUS. THE CLIENT WAS TRANSFERRED TO THE LOCAL ER/HOSPITAL; THE TIP OF THE 11MM FLEX CANNULA BROKE OFF IN THE UTERUS. THE CLIENT HAD THE CANNULA REMOVED SUCCESSFULLY AT THE HOSPITAL. MEDGYN WAS NOTIFIED OF THE INCIDENT, AND THE ATTENDING MD DISCONTINUED USE OF 11 MM FLEX CURRETTE POST INCIDENCE IN AUGUST DUE TO THE CONCERN WITH THE DEVICE. AFTER THE SECOND INCIDENT (AS REPORTED), RPTR RETURNED THE REMAINING 11 MM FLEXIBLE CURRETTES IN STOCK TO THE MANUFACTURER. DUE TO THE NATURE OF THE PROBLEM, THE AGENCY DISCONTINUED USE OF MEDGYN 11 MM FLEX CURRETTES AND FILED FORMAL REPORT(S) TO DOCUMENT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDGYN FLEXIBLE CURETTE 11MM REF. NO. 022011 11 MM FLEXIBLE CURRETTE HCY MEDGYN PRODUCTS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other