BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 1022232 · Received March 31, 2008

    Report

    Report Number
    MW5006083
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    February 13, 2007
    Report Date
    March 31, 2008
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD AN ENDOMETRIAL ABLATION DONE USING THE NOVASURE PRODUCT. I HAD A HISTORY OF ENDOMETRIOSIS WHICH WAS THE REASON FOR USING THE NOVASURE PRODUCT. HOWEVER, SINCE I HAVE HAD THE PROCEDURE DONE, I HAVE HAD ONGOING AND RECURRING OVARIAN CYSTS ON MY RIGHT OVARY. PRIOR TO THE ABLATION, I HAD NEVER HAD A CYST. I BELIEVE THAT I SHOULD BE GIVEN ACCURATE AND CURRENT INFORMATION WHEN ASKED TO MAKE A MEDICAL DECISION AND IN THIS CASE AN ELECTIVE ONE. DATES OF USE: 2007. DIAGNOSIS OR REASON FOR USE: ENDOMETRIOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE ENDOMETRIAL ABLATION MNB

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other