BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6921593 · Received October 6, 2017

    Report

    Report Number
    2951250-2017-04373
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    August 10, 2013
    Report Date
    May 29, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("MISCARRIAGE FROM AN ECTOPIC PREGNANCY") AND ABORTION OF ECTOPIC PREGNANCY ("MISCARRIAGE FROM AN ECTOPIC PREGNANCY") IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863566) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ABLATION" ON 9-JUL-2013 AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 3 (B)(6) 2001, (B)(6) 2004, (B)(6) 2010), MULTI GRAVIDA, DYSFUNCTIONAL UTERINE BLEEDING, GESTATIONAL DIABETES, ANEMIA, OVARIAN CYST, MENSES IRREGULAR, PALPITATIONS AND VOMITING. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA AND NUVA RING. CONCURRENT CONDITIONS INCLUDED ABDOMINAL PAIN, NAUSEATED, BLOATING, MENORRHAGIA AND ENDOMETRIAL ABLATION ON 9-JUL-2013. CONCOMITANT PRODUCTS INCLUDED HYDROCODONE SINCE JULY 2013, IBUPROFEN SINCE JULY 2013 AND OXYCOCET (PERCOCET) SINCE JULY 2013. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN JULY 2013, THE PATIENT EXPERIENCED HIRSUTISM ("FACIAL HAIR GROWTH"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY/MENTAL ANGUISH,"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2017, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA") AND VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABORTION OF ECTOPIC PREGNANCY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("MENSTRUAL BLEEDING") AND PELVIC PAIN ("PERSISTENT PELVIC PAIN/ PAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. AT THE TIME OF THE REPORT, THE ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION OF ECTOPIC PREGNANCY, MENSTRUAL DISORDER, PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, HIRSUTISM, DEPRESSION, ANXIETY, DYSMENORRHOEA, DYSPAREUNIA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABORTION OF ECTOPIC PREGNANCY, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, HIRSUTISM, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 36.3 KG/SQM. HYSTEROSALPINGOGRAM - ON 10-JUL-2014: CONFIRMED ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED . CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORDS: MEDICAL DEVICE MONITORING ERROR AND ECTOPIC PREGNANCY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-JUL-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORD RECEIVED: REPORTER, CONCOMITANT DISEASE AND MEDICATION, HISTORICAL CONDITION AND DRUG, ESSURE LOT NUMBER 863566, EVENTS (ABNORMAL BLEEDING, (VAGINAL, MENORRHAGIA), HORMONAL CHANGES DESCRIBE: FACIAL HAIR GROWTH, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, DEPRESSION, AND MENTAL ANGUISH, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PAIN, WEIGHT GAIN AND ABLATION 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.

    Additional Manufacturer Narrative · 0

    PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("MISCARRIAGE FROM AN ECTOPIC PREGNANCY"), ABORTION OF ECTOPIC PREGNANCY ("MISCARRIAGE FROM AN ECTOPIC PREGNANCY") AND MENORRHAGIA ("MENORRHAGIA") IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863566) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ABLATION" ON (B)(6) 2013 AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 3 ((B)(6) , (B)(6) , (B)(6) ), MULTI GRAVIDA, DYSFUNCTIONAL UTERINE BLEEDING, GESTATIONAL DIABETES, ANEMIA, OVARIAN CYST, MENSES IRREGULAR, PALPITATIONS AND VOMITING. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA FROM 2001 TO 2003, MIRENA AND NUVA RING. CONCURRENT CONDITIONS INCLUDED ABDOMINAL PAIN, NAUSEATED, BLOATING, MENORRHAGIA AND ENDOMETRIAL ABLATION (ON (B)(6) 2013). CONCOMITANT PRODUCTS INCLUDED HYDROCODONE SINCE (B)(6) 2013, IBUPROFEN SINCE (B)(6) 2013 AND OXYCOCET (PERCOCET) SINCE (B)(6) 2013. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED HIRSUTISM ("FACIAL HAIR GROWTH"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY/MENTAL ANGUISH,"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN ("PERSISTENT PELVIC PAIN/ PAIN") AND ABDOMINAL PAIN ("PAIN ABDOMINAL"). ON (B)(6) 2014, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABORTION OF ECTOPIC PREGNANCY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENSTRUAL DISORDER ("MENSTRUAL BLEEDING"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (ABLATION). AT THE TIME OF THE REPORT, THE ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION OF ECTOPIC PREGNANCY, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL HAEMORRHAGE, HIRSUTISM, DEPRESSION, ANXIETY, DYSMENORRHOEA, DYSPAREUNIA, WEIGHT INCREASED AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION OF ECTOPIC PREGNANCY, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, HIRSUTISM, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.4 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: CONFIRMED ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORDS: MEDICAL DEVICE MONITORING ERROR AND ECTOPIC PREGNANCY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-NOV-2018: PLAINTIFF FACT SHEET RECEIVED : EVENT "PAIN ABDOMINAL" ADDED. PREGNANCY OUTCOME WAS UPDATED TO SPONTANEOUS ABORTION. 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 ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("MISCARRIAGE FROM AN ECTOPIC PREGNANCY") AND ABORTION OF ECTOPIC PREGNANCY ("MISCARRIAGE FROM AN ECTOPIC PREGNANCY") IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863566) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ABLATION" ON 9-JUL-2013 AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 3 ((B)(6) 2001, (B)(6) 2004, (B)(6) 2010), MULTI GRAVIDA, DYSFUNCTIONAL UTERINE BLEEDING, GESTATIONAL DIABETES, ANEMIA, OVARIAN CYST, MENSES IRREGULAR, PALPITATIONS AND VOMITING. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA AND NUVA RING. CONCURRENT CONDITIONS INCLUDED ABDOMINAL PAIN, NAUSEATED, BLOATING, MENORRHAGIA AND ENDOMETRIAL ABLATION (ON 9-JUL-2013). CONCOMITANT PRODUCTS INCLUDED HYDROCODONE SINCE (B)(6) 2013, IBUPROFEN SINCE (B)(6) 2013 AND OXYCOCET (PERCOCET) SINCE (B)(6) 2013. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED HIRSUTISM ("FACIAL HAIR GROWTH"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY/MENTAL ANGUISH,"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2017, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA") AND VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABORTION OF ECTOPIC PREGNANCY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("MENSTRUAL BLEEDING") AND PELVIC PAIN ("PERSISTENT PELVIC PAIN/ PAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. AT THE TIME OF THE REPORT, THE ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION OF ECTOPIC PREGNANCY, MENSTRUAL DISORDER, PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, HIRSUTISM, DEPRESSION, ANXIETY, DYSMENORRHOEA, DYSPAREUNIA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABORTION OF ECTOPIC PREGNANCY, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, HIRSUTISM, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 36.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: CONFIRMED ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORDS: MEDICAL DEVICE MONITORING ERROR AND ECTOPIC PREGNANCY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-AUG-2018: QUALITY-SAFETY EVALUATION OF 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

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PERSISTENT PELVIC PAIN/ PAIN'), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ('MISCARRIAGE FROM AN ECTOPIC PREGNANCY'), ABORTION OF ECTOPIC PREGNANCY ('MISCARRIAGE FROM AN ECTOPIC PREGNANCY') AND MENORRHAGIA ('MENORRHAGIA') IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863566) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ABLATION" ON (B)(6) 2013 AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 3 (B)(6) 2001, (B)(6) 2004, (B)(6) 2010, MULTI GRAVIDA, DYSFUNCTIONAL UTERINE BLEEDING, GESTATIONAL DIABETES, ANEMIA, OVARIAN CYST, MENSES IRREGULAR, PALPITATIONS, VOMITING AND C-SECTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA FROM 2001 TO 2003, MIRENA AND NUVA RING. CONCURRENT CONDITIONS INCLUDED ABDOMINAL PAIN, NAUSEATED, BLOATING, MENORRHAGIA, ENDOMETRIAL ABLATION (ON (B)(6) 2013 AND ASTHMA. CONCOMITANT PRODUCTS INCLUDED HYDROCODONE SINCE JULY 2013, IBUPROFEN SINCE JULY 2013, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET) SINCE JULY 2013 AND PIROXICAM (PAXIL). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN JULY 2013, THE PATIENT EXPERIENCED HIRSUTISM ("FACIAL HAIR GROWTH"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY/MENTAL ANGUISH,") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("PAIN ABDOMINAL"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2014, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"). ON (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE AN ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABORTION OF ECTOPIC PREGNANCY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUAL DISORDER ("MENSTRUAL BLEEDING") AND DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND HYSTERECTOMY AND BILATERAL SALPINGECTOMY)). AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, ABDOMINAL PAIN AND DYSFUNCTIONAL UTERINE BLEEDING HAD RESOLVED AND THE ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION OF ECTOPIC PREGNANCY, MENSTRUAL DISORDER, HIRSUTISM, DEPRESSION, ANXIETY, DYSMENORRHOEA, DYSPAREUNIA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION OF ECTOPIC PREGNANCY, ANXIETY, DEPRESSION, DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHOEA, DYSPAREUNIA, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, HIRSUTISM, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN AND BLEEDING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.4 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: RESULTS: CONFIRMED ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORDS: MEDICAL DEVICE MONITORING ERROR AND ECTOPIC PREGNANCY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PPF RECEIVED OUTCOME OF EVENT " PAIN AND BLEEDING" WERE UPDATED AS RECOVERED. REPORTER INFORMATION WAS ADDED. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PERSISTENT PELVIC PAIN/ PAIN'), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ('MISCARRIAGE FROM AN ECTOPIC PREGNANCY'), ABORTION OF ECTOPIC PREGNANCY ('MISCARRIAGE FROM AN ECTOPIC PREGNANCY') AND MENORRHAGIA ('MENORRHAGIA') IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863566) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ABLATION" ON (B)(6) 2013 AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 3 ((B)(6) 2001, (B)(6) 2004, (B)(6) 2010), MULTI GRAVIDA, DYSFUNCTIONAL UTERINE BLEEDING, GESTATIONAL DIABETES, ANEMIA, OVARIAN CYST, MENSES IRREGULAR, PALPITATIONS, VOMITING AND C-SECTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA FROM 2001 TO 2003, MIRENA AND NUVA RING. CONCURRENT CONDITIONS INCLUDED ABDOMINAL PAIN, NAUSEATED, BLOATING, MENORRHAGIA, ENDOMETRIAL ABLATION (ON (B)(6) 2013) AND ASTHMA. CONCOMITANT PRODUCTS INCLUDED HYDROCODONE SINCE (B)(6) 2013, IBUPROFEN SINCE (B)(6) 2013, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET) SINCE (B)(6) 2013 AND PIROXICAM (PAXIL). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED HIRSUTISM ("FACIAL HAIR GROWTH"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY/MENTAL ANGUISH,") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("PAIN ABDOMINAL"). ON(B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2014, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"). ON (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE AN ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABORTION OF ECTOPIC PREGNANCY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUAL DISORDER ("MENSTRUAL BLEEDING") AND DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND HYSTERECTOMY AND BILATERAL SALPINGECTOMY)). AT THE TIME OF THE REPORT, THE PELVIC PAIN, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION OF ECTOPIC PREGNANCY, MENORRHAGIA, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, HIRSUTISM, DEPRESSION, ANXIETY, DYSMENORRHOEA, DYSPAREUNIA, WEIGHT INCREASED, ABDOMINAL PAIN AND DYSFUNCTIONAL UTERINE BLEEDING OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION OF ECTOPIC PREGNANCY, ANXIETY, DEPRESSION, DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHOEA, DYSPAREUNIA, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, HIRSUTISM, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.4 KG/SQM. HYSTEROSALPINGOGRAM ON (B)(6) -2014: RESULTS: CONFIRMED ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORDS: MEDICAL DEVICE MONITORING ERROR AND ECTOPIC PREGNANCY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON(B)(6) 2020: PFS RECEIVED- NEW EVENT DYSFUNCTIONAL UTERINE BLEEDING WAS ADDED. REPORTER INFORMATION WAS ADDED. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT 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 RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("MISCARRIAGE FROM AN ECTOPIC PREGNANCY") AND ABORTION OF ECTOPIC PREGNANCY ("MISCARRIAGE FROM AN ECTOPIC PREGNANCY") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABORTION OF ECTOPIC PREGNANCY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("MENSTRUAL BLEEDING") AND PELVIC PAIN ("PERSISTENT PELVIC PAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. AT THE TIME OF THE REPORT, THE ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION OF ECTOPIC PREGNANCY, MENSTRUAL DISORDER AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABORTION OF ECTOPIC PREGNANCY, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: CONFIRMED ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. 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
    703741 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 863566

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other| R DEPO PROVERA| DEPO PROVERA| HYDROCODONE| HYDROCODONE| HYDROCODONE| HYDROCODONE| HYDROCODONE| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| PAXIL [PIROXICAM]| PAXIL [PIROXICAM]| PERCOCET| PERCOCET| PERCOCET| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]