BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE CONTRACEPTIVE DEVICE (KNH)

    MDR report key: 1639125 · Received March 24, 2010

    Report

    Report Number
    MW5015262
    Event Type
    Injury
    Date Received
    March 24, 2010
    Date of Event
    March 27, 2009
    Report Date
    March 24, 2010
    Manufacturer
    CONCEPTUS (CONCEPTUS)
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DEVICE IMPLANTED (B) (6) 2009. PATIENT TOOK BIRTH CONTROL AS DIRECTED FOR 3 MONTHS FOLLOWING PROCEDURE. HSG DONE (B) (6) 2009 - POSITIVE TUBAL OCCLUSION. POSITIVE PREGNANCY TEST ON (B) (6) 2009. PATIENT (B) (6) PREGNANT. NO COMPLICATIONS TO FETUS. DEVICE CANNOT BE REMOVED PER PHYSICIAN. PATIENT WILL HAVE ADDITIONAL PROCEDURE AFTER GIVING BIRTH TO ENSURE PREGNANCY WILL NOT HAPPEN AGAIN. PATIENT FEELS THAT PREGNANCY TEST SHOULD BE MANDATORY BEFORE HSG TEST DONE TO ELIMINATE UNNECESSARY XRAY EXPOSURE. ALSO, IT SHOULD BE RECOMMENDED THAT BIRTH CONTROL BE EXTENDED TO 5 OR 6 MONTHS POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    0 ESSURE CONTRACEPTIVE DEVICE (KNH) TUBAL OCCLUSION CONTRACEPTIVE DEVICE HHS CONCEPTUS (CONCEPTUS)

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other