BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6999993 · Received November 3, 2017

    Report

    Report Number
    2951250-2017-05963
    Event Type
    Injury
    Date Received
    November 3, 2017
    Report Date
    November 3, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("UNINTENDED ECTOPIC PREGNANCY (SECOND EPISODE)") IN A FEMALE PATIENT WHO HAD ESSURE (B)(4) INSERTED FOR FEMALE STERILIZATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (PLAINTIFF HAD THREE UNINTENDED ECTOPIC PREGNANCIES). IN (B)(4) 2003, THE PATIENT HAD ESSURE (B)(4) INSERTED. ON AN UNKNOWN DATE, 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. THE PATIENT HAD ESSURE (B)(4) DURING THE FIRST TRIMESTER OF PREGNANCY. 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 (B)(4). THE REPORTER COMMENTED: PLAINTIFF HAD THREE UNINTENDED ECTOPIC PREGNANCIES. THIS CASE REFERS TO THE SECOND ECTOPIC PREGNANCY, FOR ADDITIONAL EPISODES PLEASE REFER TO CASE 2017-193617 AND 2017-193625. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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
    779254 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS205

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R