BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8013520 · Received October 29, 2018

    Report

    Report Number
    2951250-2018-04458
    Event Type
    Injury
    Date Received
    October 29, 2018
    Date of Event
    January 1, 2014
    Report Date
    October 29, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "ROSPECTIVE" PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("ECTOPIC PREGNANCY") IN AN ADULT FEMALE PATIENT (GRAVIDA 4, PARA 2) WHO HAD ESSURE (BATCH NO. 893029) INSERTED FOR FEMALE STERILISATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" IN 2014. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MISCARRIAGE IN 2013. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. AT THE TIME OF THE REPORT, THE ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PLAINTIFF EXPERIENCED THREE PREVIOUS PREGNANCY EPISODES IN 2013, 2014 AND 2016 CAPTURED UNDER THE CASES (B)(4) RESPECTIVELY. ON (B)(6) 2016, SHE HAD UNILATERAL SALPINGECTOMY-DIAGNOSTIC LAPAROSCOPY AND LEFT SALPINGECTOMY AND REMOVAL OF LEFT ESSURE COIL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-OCT-2018: QUALITY SAFETY EVALUATION OF PTC. AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854109 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 893029 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other| R