BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9631130 · Received January 27, 2020

    Report

    Report Number
    2951250-2020-00591
    Event Type
    Injury
    Date Received
    January 27, 2020
    Report Date
    January 27, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PREGNANCY WITH CONTRACEPTIVE DEVICE ('POSTIMPLANT PREGNANCY') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 740666,683283) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN"). AT THE TIME OF THE REPORT, THE PREGNANCY WITH CONTRACEPTIVE DEVICE AND PELVIC PAIN OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: PROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS UNKNOWN TO THE REPORTER. THE REPORTER CONSIDERED PELVIC PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: LOT NUMBER:683283 MANUFACTURE DATE: 2009-10 EXPIRATION DATE: 2012-10. LOT NUMBER:740666 MANUFACTURE DATE: 2010-05 EXPIRATION DATE: 2013-05. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-JUN-2019: UNLOCKED FOR QUALITY SAFETY EVALUATION. AMENDMENT: THE REPORT WAS ALSO AMENDED FOR THE FOLLOWING REASON: THE CASE 2019-003539 WILL BE DELETED FROM BAYER PV DATABASE BECAUSE THIS IS A DUPLICATE FROM 2018-242967 CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95268 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 740666,683283 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other