BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9961587 · Received April 15, 2020

    Report

    Report Number
    2951250-2020-03859
    Event Type
    Injury
    Date Received
    April 15, 2020
    Report Date
    June 16, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('TWO MONTH LONG MESTRUAL CYCLE') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION ("PASSED THE COIL IN MY LEFT TUBE DURING A TWO MONTH LONG MESTRUAL CYCLE"), AMENORRHOEA ("MY CYCLE STOPPED") AND BREAST TENDERNESS ("BREAST TENDER AND SORE") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY WITH ESSURE (MY E-BABY IS A GIRL)"). THE PATIENT WAS TREATED WITH SURGERY (EFREE IN (B)(6) 2016). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE MENORRHAGIA, DEVICE EXPULSION, PREGNANCY WITH CONTRACEPTIVE DEVICE, AMENORRHOEA AND BREAST TENDERNESS OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED AMENORRHOEA, BREAST TENDERNESS, DEVICE EXPULSION, MENORRHAGIA AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-JUN-2020: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('TWO MONTH LONG MENSTRUAL CYCLE') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION ("PASSED THE COIL IN MY LEFT TUBE DURING A TWO MONTH LONG MESTRUAL CYCLE"), AMENORRHOEA ("MY CYCLE STOPPED") AND BREAST TENDERNESS ("BREAST TENDER AND SORE") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY WITH ESSURE (MY E-BABY IS A GIRL)"). THE PATIENT WAS TREATED WITH SURGERY (EFREE IN (B)(6) 2016). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE MENORRHAGIA, DEVICE EXPULSION, PREGNANCY WITH CONTRACEPTIVE DEVICE, AMENORRHOEA AND BREAST TENDERNESS OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED AMENORRHOEA, BREAST TENDERNESS, DEVICE EXPULSION, MENORRHAGIA AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-MAR-2020: SOCIAL MEDIA RECEIVED. CASE BECAME INCIDENT. NEW EVENTS ADDED MENORRHAGIA, AMENORRHEA, DEVICE EXPULSION AND BREAST TENDERNESS. PREGNANCY OUTCOME WAS UPDATED. ON 20-MAR-2020: NO NEW INFORMATION RECEIVED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426459 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R