BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9248521 · Received October 29, 2019

    Report

    Report Number
    2951250-2019-10834
    Event Type
    Injury
    Date Received
    October 29, 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 ('SCHEDULING HYSTERECTOMY') AND HAEMORRHAGIC OVARIAN CYST ('ALSO HAVE A 5 CM CYST WITH BLOODY SUBSTANCE') 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 HAEMORRHAGIC OVARIAN CYST (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND OVARIAN ENLARGEMENT ("MY LEFT OVARY IS DOUBLE THE SIZIE SHOULD BE") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("UTERUS HAS FIBROIDS"). THE PATIENT WAS TREATED WITH SURGERY (SCHEDULING HYSTERECTOMY IN APRIL). AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, HAEMORRHAGIC OVARIAN CYST, UTERINE LEIOMYOMA AND OVARIAN ENLARGEMENT OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED HAEMORRHAGIC OVARIAN CYST, MEDICAL DEVICE REMOVAL, OVARIAN ENLARGEMENT AND UTERINE LEIOMYOMA TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: MEDICAL DEVICE REMOVAL, UTERINE LEIOMYOMA, OVARIAN ENLARGEMENT, HAEMORRHAGIC OVARIAN CYST. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: WITH QUALITY-SAFETY EVALUATION OF PTC IT WAS DETECTED THAT THIS RECORD IS A DUPLICATE TO RECORD 2018-122551 TO WHICH ALL INFORMATION WAS TRANSFERRED, THEN THIS DUPLICATE RECORD 2019-193329 WILL BE DELETED. 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 ('SCHEDULING HYSTERECTOMY') AND HAEMORRHAGIC OVARIAN CYST ('ALSO HAVE A 5 CM CYST WITH BLOODY SUBSTANCE') 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 HAEMORRHAGIC OVARIAN CYST (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND OVARIAN ENLARGEMENT ("MY LEFT OVARY IS DOUBLE THE SIZIE SHOULD BE") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("UTERUS HAS FIBROIDS"). THE PATIENT WAS TREATED WITH SURGERY (SCHEDULING HYSTERECTOMY IN (B)(6)). AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, HAEMORRHAGIC OVARIAN CYST, UTERINE LEIOMYOMA AND OVARIAN ENLARGEMENT OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED HAEMORRHAGIC OVARIAN CYST, MEDICAL DEVICE REMOVAL, OVARIAN ENLARGEMENT AND UTERINE LEIOMYOMA TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: MEDICAL DEVICE REMOVAL, UTERINE LEIOMYOMA, OVARIAN ENLARGEMENT, HAEMORRHAGIC OVARIAN CYST. 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-CONFORMANCE 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
    1044254 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R