BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9260368 · Received October 31, 2019

    Report

    Report Number
    2951250-2019-10917
    Event Type
    Injury
    Date Received
    October 31, 2019
    Report Date
    November 1, 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 LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('EFREE / GETTING TAKEN (TUBES, CERVIX, OVARIES, UTERUS)') 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 UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EXPERIENCED OVARIAN CYST ("CYSTS/ CYSTS ON MY OVARIES") AND OVARIAN CYST RUPTURED ("2 BIG ONES HAVE RUPTURED") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("FIBROIDS") AND NEOPLASM ("TUMORS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL SURGERY REMOVE TUBES, CERVIX, OVARIES, UTERUS.). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, OVARIAN CYST, UTERINE LEIOMYOMA, NEOPLASM AND OVARIAN CYST RUPTURED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL, NEOPLASM, OVARIAN CYST, OVARIAN CYST RUPTURED AND UTERINE LEIOMYOMA TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: MEDICAL DEVICE REMOVAL, OVARIAN CYST, UTERINE LEIOMYOMA, NEOPLASM AND OVARIAN CYST RUPTURED. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: THIS CASE WILL BE DELETED FROM BAYER PV DATABASE. NULLIFICATION REASON: IT WAS IDENTIFIED AS DUPLICATE OF CASE (B)(4). 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 MEDICAL DEVICE REMOVAL ('EFREE / GETTING TAKEN (TUBES, CERVIX, OVARIES, UTERUS)') 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 UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EXPERIENCED OVARIAN CYST ("CYSTS/ CYSTS ON MY OVARIES") AND OVARIAN CYST RUPTURED ("2 BIG ONES HAVE RUPTURED") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("FIBROIDS") AND NEOPLASM ("TUMORS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL SURGERY REMOVE TUBES, CERVIX, OVARIES, UTERUS.). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, OVARIAN CYST, UTERINE LEIOMYOMA, NEOPLASM AND OVARIAN CYST RUPTURED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL, NEOPLASM, OVARIAN CYST, OVARIAN CYST RUPTURED AND UTERINE LEIOMYOMA TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: MEDICAL DEVICE REMOVAL, OVARIAN CYST, UTERINE LEIOMYOMA, NEOPLASM AND OVARIAN CYST RUPTURED. 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
    1057895 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R