BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8198579 · Received December 27, 2018

    Report

    Report Number
    2951250-2018-05347
    Event Type
    Injury
    Date Received
    December 27, 2018
    Report Date
    February 19, 2019
    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 CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF PREMATURE DELIVERY ("PRETERM DELIVERY") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY WITH COMPLICATION") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 020870-INV 641415) INSERTED FOR FEMALE STERILIZATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6)2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PREMATURE DELIVERY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ESSURE WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE PREMATURE DELIVERY AND PREGNANCY WITH CONTRACEPTIVE DEVICE 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 THIRD TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A CHILD WITH HEALTH PROBLEMS. THE REPORTER CONSIDERED PREGNANCY WITH CONTRACEPTIVE DEVICE AND PREMATURE DELIVERY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PLAINTIFF EXPERIENCED PREVIOUS PREGNANCY EPISODES WAS CAPTURED UNDER THE CASES (B)(64 (BABY CASE) RESPECTIVELY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-FEB-2019: QUALITY-SAFETY EVALUATION OF PTC(PRODUCT TECHNICAL COMPLAINT). INCIDENT: WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF PREMATURE DELIVERY ("PRETERM DELIVERY") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY WITH COMPLICATION") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 020870/641415) INSERTED. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PREMATURE DELIVERY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PREMATURE DELIVERY AND PREGNANCY WITH CONTRACEPTIVE DEVICE 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 THIRD TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A CHILD WITH HEALTH PROBLEMS. THE REPORTER CONSIDERED PREGNANCY WITH CONTRACEPTIVE DEVICE AND PREMATURE DELIVERY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PLAINTIFF EXPERIENCED TWO PREVIOUS PREGNANCY EPISODES WAS CAPTURED UNDER THE CASES (B)(4) RESPECTIVELY. INCIDENT: WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040584 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 020870-INV 641415 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R