BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9502482 · Received December 20, 2019

    Report

    Report Number
    2951250-2019-13633
    Event Type
    Injury
    Date Received
    December 20, 2019
    Report Date
    April 13, 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 PELVIC PAIN ('PAIN') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE INFLAMMATION ("INFLAMMATION OF RIGHT CORNUE") AND OVARIAN CYST ("CYSTIC AREA IN RIGHT OVARY"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL SURGERY FOR ESSURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, UTERINE INFLAMMATION AND OVARIAN CYST OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED OVARIAN CYST, PELVIC PAIN AND UTERINE INFLAMMATION TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S SOCIAL MEDIA:OVARIAN CYST, PELVIC PAIN AND UTERINE INFLAMMATION AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: UPON RECEIVING A INTERNAL CONFIRMATION, IT WAS CONFIRMED THAT CASES (B)(4) (BUS-2019-US-044741), (B)(4) (BUS-2019-US-075024 ) AND (B)(4) (BUS-2019-US-072216 ) DUPLICATES OF EACH OTHER. ALL THE INFORMATION FROM THE DELETION CASE (B)(4) AND (B)(4) WAS TRANSFERRED TO RETENTION CASE (B)(4) . NULLIFICATION REASON: DUPLICATE CASE IS IDENTIFIED WITH FOLLOW-UP INFORMATION. THIS CASE IS MARKED FOR DELETION. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS 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 PELVIC PAIN ('PAIN') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE INFLAMMATION ("INFLAMMATION OF RIGHT CORNUE") AND OVARIAN CYST ("CYSTIC AREA IN RIGHT OVARY"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL SURGERY FOR ESSURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, UTERINE INFLAMMATION AND OVARIAN CYST OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED OVARIAN CYST, PELVIC PAIN AND UTERINE INFLAMMATION TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S SOCIAL MEDIA:OVARIAN CYST, PELVIC PAIN AND UTERINE INFLAMMATION. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301594 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R