BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10382204 · Received August 7, 2020

    Report

    Report Number
    2951250-2020-12929
    Event Type
    Injury
    Date Received
    August 7, 2020
    Report Date
    August 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('MENORRHAGIA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ABDOMINAL PAIN, FEVER, NAUSEA, VOMITING, ASTHMA, DEPRESSION, LOW BACK PAIN, FLANK PAIN, HEMORRHAGIC CYST AND UTERINE FIBROIDS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: PHENERGAN, SUDAFED AND IMODIUM. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUATION IRREGULAR ("IRREGULAR CYCLES"), DYSMENORRHOEA ("DYSMENORRHEA") AND OBESITY ("OBESITY") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("FIBROID UTERUS"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND CYSTOSCOPY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE MENORRHAGIA, MENSTRUATION IRREGULAR, DYSMENORRHOEA, UTERINE LEIOMYOMA AND OBESITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, MENORRHAGIA, MENSTRUATION IRREGULAR, OBESITY AND UTERINE LEIOMYOMA TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-AUG-2020: QUALITY-SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION 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 MENORRHAGIA ('MENORRHAGIA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ABDOMINAL PAIN, FEVER, NAUSEA, VOMITING, ASTHMA, DEPRESSION, LOW BACK PAIN, FLANK PAIN, HEMORRHAGIC CYST AND UTERINE FIBROIDS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: PHENERGAN, SUDAFED AND IMODIUM. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUATION IRREGULAR ("IRREGULAR CYCLES"), DYSMENORRHOEA ("DYSMENORRHEA") AND OBESITY ("OBESITY") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("FIBROID UTERUS"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND CYSTOSCOPY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE MENORRHAGIA, MENSTRUATION IRREGULAR, DYSMENORRHOEA, UTERINE LEIOMYOMA AND OBESITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, MENORRHAGIA, MENSTRUATION IRREGULAR, OBESITY AND UTERINE LEIOMYOMA TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845143 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R