BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7056052 · Received November 23, 2017

    Report

    Report Number
    2951250-2017-07896
    Event Type
    Injury
    Date Received
    November 23, 2017
    Date of Event
    January 1, 2012
    Report Date
    November 8, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (WITH COMPLICATIONS)"), MENOMETRORRHAGIA ("MENOMETRORRHAGIA") AND GESTATIONAL TROPHOBLASTIC TUMOUR ("PLACENTAL SITE TROPHOBLASTIC TUMOUR") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841533) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENOMETRORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN 2013, THE PATIENT EXPERIENCED GESTATIONAL TROPHOBLASTIC TUMOUR (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URINARY TRACT INFECTION ("INFECTION: URINARY"), CYSTITIS ("INFECTION: BLADDER"), BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, MENOMETRORRHAGIA, GESTATIONAL TROPHOBLASTIC TUMOUR, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, CYSTITIS, BACTERIAL VAGINOSIS, BLADDER DISORDER, URINARY TRACT DISORDER, DYSMENORRHOEA, VAGINAL DISCHARGE AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE HAD RESOLVED. THE PREGNANCY OUTCOME WAS UNKNOWN TO THE REPORTER. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACTERIAL VAGINOSIS, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, GENITAL HAEMORRHAGE, GESTATIONAL TROPHOBLASTIC TUMOUR, MENOMETRORRHAGIA, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS: ON UNKNOWN DATE, ESSURE CONFIRMATION TEST WAS PERFORMED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED. NEW REPORTERS ADDED. PATIENT DEMOGRAPHIC INFORMATION ADDED. . ESSURE INSERTION DATE UPDATED TO (B)(6) 2011 AND REMOVAL DATE UPDATED TO (B)(6) 2014. INDICATION (PERMANENT BIRTH CONTROL BY BILATERAL OCCLUSION OF THE FALLOPIAN TUBES) ADDED LOT NUMBER ADDED. EVENTS PREGNANCY (WITH COMPLICATIONS), ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), INFECTION: URINARY, INFECTION: BLADDER, BACTERIAL VAGINOSIS, BLADDER PROBLEMS OR CHANGES, URINARY PROBLEMS OR CHANGES, DYSMENORRHEA (CRAMPING), DEVICE INEFFECTIVE, PLACENTAL SITE TROPHOBLASTIC TUMOUR), VAGINAL DISCHARGE AND ABDOMINAL PAIN ADDED ON (B)(6) 2018: PREGNANCY WAS CHANGED FROM "UNK" TO "YES." INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (WITH COMPLICATIONS)"), MENOMETRORRHAGIA ("MENOMETRORRHAGIA") AND GESTATIONAL TROPHOBLASTIC TUMOUR ("PLACENTAL SITE TROPHOBLASTIC TUMOUR") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841533) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENOMETRORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN 2013, THE PATIENT EXPERIENCED GESTATIONAL TROPHOBLASTIC TUMOUR (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URINARY TRACT INFECTION ("INFECTION: URINARY"), CYSTITIS ("INFECTION: BLADDER"), BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, MENOMETRORRHAGIA, GESTATIONAL TROPHOBLASTIC TUMOUR, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, CYSTITIS, BACTERIAL VAGINOSIS, BLADDER DISORDER, URINARY TRACT DISORDER, DYSMENORRHOEA, VAGINAL DISCHARGE AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE HAD RESOLVED. THE PREGNANCY OUTCOME WAS UNKNOWN TO THE REPORTER. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACTERIAL VAGINOSIS, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, GENITAL HAEMORRHAGE, GESTATIONAL TROPHOBLASTIC TUMOUR, MENOMETRORRHAGIA, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS: ON UNKNOWN DATE, ESSURE CONFIRMATION TEST WAS PERFORMED QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-AUG-2018: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT ) INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), ABORTION SPONTANEOUS ("MISCARRIAGE"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (WITH COMPLICATIONS)"), DEVICE DISLOCATION ("THEY COULDN'T FIND ANY OF THE COILS"), MENOMETRORRHAGIA ("MENOMETRORRHAGIA") AND GESTATIONAL TROPHOBLASTIC TUMOUR ("PLACENTAL SITE TROPHOBLASTIC TUMOUR") IN AN ADULT FEMALE PATIENT (GRAVIDA 5, PARA 4) WHO HAD ESSURE (BATCH NO: 841533) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND PARITY 4 ((B)(6) 1995/ (B)(6)2003/ (B)(6) 2006/ (B)(6) 2011). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENOMETRORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)", MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)" AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)". IN 2013, THE PATIENT EXPERIENCED GESTATIONAL TROPHOBLASTIC TUMOUR (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URINARY TRACT INFECTION ("INFECTION: URINARY"), CYSTITIS ("INFECTION: BLADDER"), BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, DEVICE DISLOCATION, MENOMETRORRHAGIA, GESTATIONAL TROPHOBLASTIC TUMOUR, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, CYSTITIS, BACTERIAL VAGINOSIS, BLADDER DISORDER, URINARY TRACT DISORDER, DYSMENORRHOEA, VAGINAL DISCHARGE AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE HAD RESOLVED. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, BACTERIAL VAGINOSIS, BLADDER DISORDER, CYSTITIS, DEVICE DISLOCATION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, GESTATIONAL TROPHOBLASTIC TUMOUR, MENOMETRORRHAGIA, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS: ON UNKNOWN DATE, ESSURE CONFIRMATION TEST WAS PERFORMED. ESSURE CONFIRMATION TEST RESULTS: THAT THINGS WERE FINE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-OCT-2018: PLAINTIFF FACT SHEET RECEIVED. EVENTS PER PFS: THEY COULDN'T FIND ANY OF THE COILS AND MISCARRIAGE WERE ADDED. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE). ESSURE WAS REMOVED IN 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835096 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 841533

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other| R