ESSURE
Report
- Report Number
- 2951250-2017-03710
- Event Type
- Injury
- Date Received
- September 18, 2017
- Date of Event
- January 1, 2011
- Report Date
- May 26, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN / PAIN"), ABORTION SPONTANEOUS ("MISCARRIAGE"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("MISCARRIAGE / PREGNANCY") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 23-YEAR-OLD FEMALE PATIENT (GRAVIDA 9, PARA 5) WHO HAD ESSURE (BATCH NO. 863568/ 880434) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT PERFORMED ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 5 (DATE OF BIRTH: (B)(6) 2003, (B)(6) 2006, (B)(6) 20058, (B)(6) 2009, (B)(6) 2010) AND RECURRENT ABORTION. CONCURRENT CONDITIONS INCLUDED CERVICITIS AND ENDOCERVICITIS. CONCOMITANT PRODUCTS INCLUDED PARACETAMOL (TYLENOL). IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN NOVEMBER 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2012, 9 MONTHS 14 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). IN SEPTEMBER 2017, THE PATIENT EXPERIENCED SCOLIOSIS ("SCOLIOSIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN") AND DYSPEPSIA ("HEART BURN"). 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 (BILATERAL SALPINGECTOMY - LAPAROSCOPIC). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, HORMONE LEVEL ABNORMAL, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, WEIGHT INCREASED, SCOLIOSIS, ABDOMINAL PAIN, BACK PAIN, DYSPEPSIA, DYSPAREUNIA AND DYSMENORRHOEA HAD NOT RESOLVED AND THE ABORTION SPONTANEOUS AND PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, BACK PAIN, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, SCOLIOSIS, URINARY TRACT DISORDER AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE IS STILL DEALING WITH ALL THE COMPLICATIONS, NON OF THEM WENT AWAY AFTER THE SALPINGECTOMY BATCH NUMBER: 880434 EXP DATE: JUL-2014 MAN DATE: JUL-2011 BATCH NUMBER: 863568 EXP DATE: MAY-2014 MAN DATE: MAY-2011 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 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.
ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN / PAIN"), ABORTION SPONTANEOUS ("MISCARRIAGE"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("MISCARRIAGE / PREGNANCY") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 23-YEAR-OLD FEMALE PATIENT (GRAVIDA 9, PARA 5) WHO HAD ESSURE (BATCH NO. 863568/ 880434) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT PERFORMED ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 5 (DATE OF BIRTH: (B)(6) 2003, (B)(6) 2006, (B)(6) 2008, (B))6) 2009, (B)(6) 2010) AND RECURRENT ABORTION. CONCURRENT CONDITIONS INCLUDED CERVICITIS AND ENDOCERVICITIS. CONCOMITANT PRODUCTS INCLUDED PARACETAMOL (TYLENOL). IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN OCTOBER 2011, THE PATIENT EXPERIENCED ANXIETY ("MENTAL ANGUISH") AND DEPRESSION ("DEPRESSION,"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN NOVEMBER 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2012, 9 MONTHS 14 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). IN SEPTEMBER 2017, THE PATIENT EXPERIENCED SCOLIOSIS ("SCOLIOSIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN") AND DYSPEPSIA ("HEART BURN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY - LAPAROSCOPIC). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, HORMONE LEVEL ABNORMAL, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, WEIGHT INCREASED, SCOLIOSIS, ABDOMINAL PAIN, BACK PAIN, DYSPEPSIA, DYSPAREUNIA AND DYSMENORRHOEA HAD NOT RESOLVED AND THE ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, ANXIETY, BACK PAIN, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, SCOLIOSIS, URINARY TRACT DISORDER AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE IS STILL DEALING WITH ALL THE COMPLICATIONS, NON OF THEM WENT AWAY AFTER THE SALPINGECTOMY BATCH NUMBER: 880434 EXP DATE: JUL-2014 MAN DATE: JUL-2011 . BATCH NUMBER: 863568 EXP DATE: MAY-2014 MAN DATE: MAY-2011 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED- NEW EVENTS DEPRESSION, MENTAL ANGUISH WERE ADDED. NEW REPORTER 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.
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN / PAIN"), ABORTION SPONTANEOUS ("MISCARRIAGE"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("MISCARRIAGE / PREGNANCY") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863568,880434) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT PERFORMED ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 5 (DATE OF BIRTH: (B)(6) 2003, (B)(6) 2006, (B)(6) 2008, (B)(6) 2009, (B)(6) 2010) AND RECURRENT ABORTION. CONCURRENT CONDITIONS INCLUDED CERVICITIS AND ENDOCERVICITIS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON 2011, AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA") AND WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2017, THE PATIENT EXPERIENCED SCOLIOSIS ("SCOLIOSIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN") AND DYSPEPSIA ("HEART BURN"). 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 (BILATERAL SALPINGECTOMY - LAPAROSCOPIC). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, HORMONE LEVEL ABNORMAL, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, NAUSEA AND SCOLIOSIS OUTCOME WAS UNKNOWN AND THE HEADACHE, WEIGHT INCREASED, ABDOMINAL PAIN, BACK PAIN AND DYSPEPSIA HAD RESOLVED. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, BACK PAIN, BLADDER DISORDER, DYSPEPSIA, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, SCOLIOSIS, URINARY TRACT DISORDER AND WEIGHT INCREASED TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-APR-2018: PFS RECEIVED - NEW EVENT"HORMONAL CHANGES, BLADDER PROBLEMS OR CHANGES, URINARY PROBLEMS OR CHANGES, MIGRAINES, HEADACHES, NAUSEA, WEIGHT GAIN, SCOLIOSIS, ABDOMINAL PAIN, BACK PAIN, HEART BURN, DID NOT PERFORMED ESSURE CONFIRMATION TEST" WERE ADDED. LOT NUMBER WAS ADDED. HISTORICAL AND CONCOMITANT CONDITIONS WERE ADDED. LAB DATA WAS ADDED. NEW REPORTER 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.
ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN / PAIN"), ABORTION SPONTANEOUS ("MISCARRIAGE"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("MISCARRIAGE / PREGNANCY") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 23-YEAR-OLD FEMALE PATIENT (GRAVIDA 9, PARA 5) WHO HAD ESSURE (BATCH NO. 863568) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT PERFORMED ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 5 (DATE OF BIRTH: 17JUN2003, 06AUG2006, 27DEC20058, 05NOV2009, 19DEC2010) AND RECURRENT ABORTION. CONCURRENT CONDITIONS INCLUDED CERVICITIS AND ENDOCERVICITIS. CONCOMITANT PRODUCTS INCLUDED PARACETAMOL (TYLENOL). IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2011, THE PATIENT EXPERIENCED ANXIETY ("MENTAL ANGUISH") AND DEPRESSION ("DEPRESSION,"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6)2012, 9 MONTHS 14 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). IN (B)(6) 2017, THE PATIENT EXPERIENCED SCOLIOSIS ("SCOLIOSIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN") AND DYSPEPSIA ("HEART BURN"). 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 (BILATERAL SALPINGECTOMY - LAPAROSCOPIC). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, HORMONE LEVEL ABNORMAL, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, WEIGHT INCREASED, SCOLIOSIS, ABDOMINAL PAIN, BACK PAIN, DYSPEPSIA, DYSPAREUNIA AND DYSMENORRHOEA HAD NOT RESOLVED AND THE ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, ANXIETY, BACK PAIN, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, SCOLIOSIS, URINARY TRACT DISORDER AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE IS STILL DEALING WITH ALL THE COMPLICATIONS, NON OF THEM WENT AWAY AFTER THE SALPINGECTOMY BATCH NUMBER: 880434 EXP DATE: JUL-2014 MAN DATE: JUL-2011. BATCH NUMBER: 863568 EXP DATE: MAY-2014 MAN DATE: MAY-2011. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-NOV-2018: QUALITY SAFETY EVALUATION OF PTC. 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.
ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN / PAIN"), ABORTION SPONTANEOUS ("MISCARRIAGE"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("MISCARRIAGE / PREGNANCY") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 23-YEAR-OLD FEMALE PATIENT (GRAVIDA 9, PARA 5) WHO HAD ESSURE (BATCH NO. 863568, 880434) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT PERFORMED ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 5 (DATE OF BIRTH: (B)(6) 2003, (B)(6) 2006, (B)(6) 2008, (B)(6) 2009, (B)(6) 2010) AND RECURRENT ABORTION. CONCURRENT CONDITIONS INCLUDED CERVICITIS AND ENDOCERVICITIS. CONCOMITANT PRODUCTS INCLUDED PARACETAMOL (TYLENOL). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2012, 9 MONTHS 14 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). IN (B)(6) 2017, THE PATIENT EXPERIENCED SCOLIOSIS ("SCOLIOSIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN") AND DYSPEPSIA ("HEART BURN"). 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 (BILATERAL SALPINGECTOMY - LAPAROSCOPIC). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, HORMONE LEVEL ABNORMAL, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, WEIGHT INCREASED, SCOLIOSIS, ABDOMINAL PAIN, BACK PAIN, DYSPEPSIA, DYSPAREUNIA AND DYSMENORRHOEA HAD NOT RESOLVED AND THE ABORTION SPONTANEOUS AND PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, BACK PAIN, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, SCOLIOSIS, URINARY TRACT DISORDER AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE IS STILL DEALING WITH ALL THE COMPLICATIONS, NON OF THEM WENT AWAY AFTER THE SALPINGECTOMY MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET RECEIVED: DYSMENORRHEA (CRAMPING) AND DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE) EVENT WAS 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('SEVERE PELVIC PAIN / PAIN') AND DEVICE BREAKAGE ('THERE WAS A LEFT ESSURE COIL PRESENT EXPELLING FROM PATIENT'S LEFT CORNUA AFTER PREVIOUS REMOVAL SURGERY') IN A 24-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863568, 880434) 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" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT PERFORMED ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED ESOPHAGEAL REFLUX IN 2013, UMBILICAL HERNIA ON (B)(6) 2011, OTITIS MEDIA FROM (B)(6) 2011 TO (B)(6) 2014, MULTIGRAVIDA, PARITY 5 (DATE OF BIRTH: (B)(6) 2003, (B)(6) 2006, (B)(6) 2008, (B)(6) 2009, (B)(6) 2010) AND RECURRENT ABORTION. CONCURRENT CONDITIONS INCLUDED CERVICITIS AND ENDOCERVICITIS. CONCOMITANT PRODUCTS INCLUDED BETACAROTENE;BIOFLAVONOIDS NOS;BIOTIN;CALCIUM ASCORBATE;CALCIUM PANTOTHENATE;CALCIUM PHOSPHATE;CHOLINE BITARTRATE;CHROMIC CHLORIDE;COLECALCIFEROL;COPPER SULFATE;CYANOCOBALAMIN;FOLIC ACID;HESPERIDIN;INOSITOL;IRON AMINO ACID CHELATE;LYCOPENE;LYSINE HYDROCHLORIDE;MAGNESIUM OXIDE;MANGANESE SULFATE;MOLYBDENUM TRIOXIDE;NICOTINAMIDE;PHYTOMENADIONE;POTASSIUM IODIDE;POTASSIUM SULFATE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;SELENOMETHIONINE;SILICON DIOXIDE, COLLOIDAL;SODIUM BORATE DECAHYDRATE;THIAMINE MONONITRATE;TOCOPHERYL ACID SUCCINATE;UBIDECARENONE;ZINC OXIDE (MULTIVITAMIN & MINERAL) SINCE 2009, FERROUS SULFATE (FERROUS SULPHATE ALMUS) SINCE 2009, MEDROXYPROGESTERONE ACETATE (DEPOPROVERA), PARACETAMOL (ACETAMINOPHEN) SINCE 2011, PARACETAMOL (TYLENOL 8 HOUR) SINCE 2011, PARACETAMOL (TYLENOL) AND TOPIRAMATE (TOPAMAX) SINCE 2010. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2011, THE PATIENT EXPERIENCED ANXIETY ("MENTAL ANGUISH") AND DEPRESSION ("DEPRESSION,"). ON (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). IN (B)(6) 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). IN (B)(6) 2017, THE PATIENT EXPERIENCED SCOLIOSIS ("SCOLIOSIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABORTION SPONTANEOUS ("MISCARRIAGE"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN") AND DYSPEPSIA ("HEART BURN") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("MISCARRIAGE / PREGNANCY"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY - LAPAROSCOPIC, HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED, THE DEVICE BREAKAGE, ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, HORMONE LEVEL ABNORMAL, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, WEIGHT INCREASED, SCOLIOSIS, ABDOMINAL PAIN, BACK PAIN, DYSPEPSIA, DYSPAREUNIA AND DYSMENORRHOEA HAD NOT RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 9, PARA 5. 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 SPONTANEOUS, ANXIETY, BACK PAIN, BLADDER DISORDER, DEPRESSION, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, SCOLIOSIS, URINARY TRACT DISORDER AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE IS STILL DEALING WITH ALL THE COMPLICATIONS, NONE OF THEM WENT AWAY AFTER THE SALPINGECTOMY PLAINTIFF RECEIVED TREATMENT FOR PAIN. 2-6 COILS WERE SEEN OUTSIDE THE TUBAL OSTIA. ESSURE REMOVAL DATE: (B)(6) 2020 AND (B)(6) 2013. (B)(6) 2013: BILATERAL SALPINGECTOMY WITH ESSURE REMOVAL (B)(6) 2020: LAVH, UTEROSACRAL VAULT SUSPENSION, CYSTO WITH BOTOX. BATCH NUMBER: 880434 EXP DATE: JUL-2014 MAN DATE: JUL-2011. BATCH NUMBER: 863568 EXP DATE: MAY-2014 MAN DATE: MAY-2011. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-MAY-2021: MR RECEIVED: EVENT DEVICE BREAKAGE ADDED. ESSURE REMOVAL DATE UPDATED. RCC NOTE AND REPORTER ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('SEVERE PELVIC PAIN / PAIN') AND DEVICE BREAKAGE ('THERE WAS A LEFT ESSURE COIL PRESENT EXPELLING FROM PATIENT'S LEFT CORNUA AFTER PREVIOUS REMOVAL SURGERY') IN A 24-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863568, 880434) 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" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT PERFORMED ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED ESOPHAGEAL REFLUX IN 2013, UMBILICAL HERNIA ON (B)(6) 2011, OTITIS MEDIA FROM (B)(6) 2011 TO (B)(6) 2014, MULTIGRAVIDA, PARITY 5 (DATE OF BIRTH: (B)(6) 2003, (B)(6) 2006, (B)(6) 20058, (B)(6) 2009, (B)(6) 2010) AND RECURRENT ABORTION. CONCURRENT CONDITIONS INCLUDED CERVICITIS AND ENDOCERVICITIS. CONCOMITANT PRODUCTS INCLUDED BETACAROTENE;BIOFLAVONOIDS NOS;BIOTIN;CALCIUM ASCORBATE;CALCIUM PANTOTHENATE;CALCIUM PHOSPHATE;CHOLINE BITARTRATE;CHROMIC CHLORIDE;COLECALCIFEROL;COPPER SULFATE;CYANOCOBALAMIN;FOLIC ACID;HESPERIDIN;INOSITOL;IRON AMINO ACID CHELATE;LYCOPENE;LYSINE HYDROCHLORIDE;MAGNESIUM OXIDE;MANGANESE SULFATE;MOLYBDENUM TRIOXIDE;NICOTINAMIDE;PHYTOMENADIONE;POTASSIUM IODIDE;POTASSIUM SULFATE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;SELENOMETHIONINE;SILICON DIOXIDE, COLLOIDAL;SODIUM BORATE DECAHYDRATE;THIAMINE MONONITRATE;TOCOPHERYL ACID SUCCINATE;UBIDECARENONE;ZINC OXIDE (MULTIVITAMIN & MINERAL) SINCE 2009, FERROUS SULFATE (FERROUS SULPHATE ALMUS) SINCE 2009, MEDROXYPROGESTERONE ACETATE (DEPOPROVERA), PARACETAMOL (ACETAMINOPHEN) SINCE 2011, PARACETAMOL (TYLENOL 8 HOUR) SINCE 2011, PARACETAMOL (TYLENOL) AND TOPIRAMATE (TOPAMAX) SINCE 2010. IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2011, THE PATIENT EXPERIENCED ANXIETY ("MENTAL ANGUISH") AND DEPRESSION ("DEPRESSION,"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). IN (B)(6) 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). IN (B)(6) 2017, THE PATIENT EXPERIENCED SCOLIOSIS ("SCOLIOSIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABORTION SPONTANEOUS ("MISCARRIAGE"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN") AND DYSPEPSIA ("HEART BURN") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("MISCARRIAGE / PREGNANCY"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY - LAPAROSCOPIC, HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED, THE DEVICE BREAKAGE, ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, HORMONE LEVEL ABNORMAL, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, WEIGHT INCREASED, SCOLIOSIS, ABDOMINAL PAIN, BACK PAIN, DYSPEPSIA, DYSPAREUNIA AND DYSMENORRHOEA HAD NOT RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 9, PARA 5. 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 SPONTANEOUS, ANXIETY, BACK PAIN, BLADDER DISORDER, DEPRESSION, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, SCOLIOSIS, URINARY TRACT DISORDER AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE IS STILL DEALING WITH ALL THE COMPLICATIONS, NONE OF THEM WENT AWAY AFTER THE SALPINGECTOMY PLAINTIFF RECEIVED TREATMENT FOR PAIN. 2-6 COILS WERE SEEN OUTSIDE THE TUBAL OSTIA. ESSURE REMOVAL DATE: (B)(6) 2020 AND (B)(6) 2013. (B)(6) 2013: BILATERAL SALPINGECTOMY WITH ESSURE REMOVAL. (B)(6) 2020: LAVH, UTEROSACRAL VAULT SUSPENSION, CYSTO WITH BOTOX. LOT NUMBER: 863568 MANUFACTURING DATE: 2011-05 EXPIRATION DATE: 2014-05. LOT NUMBER: 880434 MANUFACTURING DATE: 2011-07 EXPIRATION DATE: 2014-07. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-MAY-2021: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('SEVERE PELVIC PAIN / PAIN') IN A 24-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863568, 880434) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT PERFORMED ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED ESOPHAGEAL REFLUX IN 2013, UMBILICAL HERNIA ON (B)(6) 2011, OTITIS MEDIA FROM (B)(6) 2011 TO (B)(6) 2014, MULTIGRAVIDA, PARITY 5 (DATE OF BIRTH: (B)(6) 2003, (B)(6) 2006, (B)(6) 2008, (B)(6) 2009, (B)(6) 2010) AND RECURRENT ABORTION. CONCURRENT CONDITIONS INCLUDED CERVICITIS AND ENDOCERVICITIS. CONCOMITANT PRODUCTS INCLUDED BETACAROTENE;BIOFLAVONOIDS NOS;BIOTIN;CALCIUM ASCORBATE;CALCIUM PANTOTHENATE;CALCIUM PHOSPHATE;CHOLINE BITARTRATE;CHROMIC CHLORIDE;COLECALCIFEROL;COPPER SULFATE;CYANOCOBALAMIN;FOLIC ACID;HESPERIDIN;INOSITOL;IRON AMINO ACID CHELATE;LYCOPENE;LYSINE HYDROCHLORIDE;MAGNESIUM OXIDE;MANGANESE SULFATE;MOLYBDENUM TRIOXIDE;NICOTINAMIDE;PHYTOMENADIONE;POTASSIUM IODIDE;POTASSIUM SULFATE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;SELENOMETHIONINE;SILICON DIOXIDE, COLLOIDAL;SODIUM BORATE DECAHYDRATE;THIAMINE MONONITRATE;TOCOPHERYL ACID SUCCINATE;UBIDECARENONE;ZINC OXIDE (MULTIVITAMIN & MINERAL) SINCE 2009, FERROUS SULFATE (FERROUS SULPHATE ALMUS) SINCE 2009, MEDROXYPROGESTERONE ACETATE (DEPOPROVERA), PARACETAMOL (ACETAMINOPHEN) SINCE 2011, PARACETAMOL (TYLENOL 8 HOUR) SINCE 2011, PARACETAMOL (TYLENOL) AND TOPIRAMATE (TOPAMAX) SINCE 2010. IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2011, THE PATIENT EXPERIENCED ANXIETY ("MENTAL ANGUISH") AND DEPRESSION ("DEPRESSION,"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). IN (B)(6) 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). IN (B)(6) 2017, THE PATIENT EXPERIENCED SCOLIOSIS ("SCOLIOSIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS ("MISCARRIAGE"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN") AND DYSPEPSIA ("HEART BURN") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("MISCARRIAGE / PREGNANCY"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY - LAPAROSCOPIC). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED, THE ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, HORMONE LEVEL ABNORMAL, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, WEIGHT INCREASED, SCOLIOSIS, ABDOMINAL PAIN, BACK PAIN, DYSPEPSIA, DYSPAREUNIA AND DYSMENORRHOEA HAD NOT RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 9, PARA 5. 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 SPONTANEOUS, ANXIETY, BACK PAIN, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, SCOLIOSIS, URINARY TRACT DISORDER AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE IS STILL DEALING WITH ALL THE COMPLICATIONS, NON OF THEM WENT AWAY AFTER THE SALPINGECTOMY PLAINTIFF RECEIVED TREATMENT FOR PAIN BATCH NUMBER: 880434 EXP DATE: JUL-2014 MAN DATE: JUL-2011. BATCH NUMBER: 863568 EXP DATE: MAY-2014 MAN DATE: MAY-2011 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED. REPORTER INFORMATION ADDED. EVENT OUTCOME FOR PREVIOUSLY REPORTED EVENT PELVIC PAIN WAS UPDATED TO RECOVERED/RESOLVED. WE RECEIVED A LOT NUMBER IN THIS CASE. 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.
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN"), ABORTION SPONTANEOUS ("MISCARRIAGE") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("MISCARRIAGE") 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) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, MENSTRUAL DISORDER, PELVIC PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE 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 |
|---|---|---|---|---|---|---|---|
| 654129 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 863568, 880434 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| DEPOPROVERA| DEPOPROVERA| DEPOPROVERA| FERROUS SULPHATE ALMUS| FERROUS SULPHATE ALMUS| FERROUS SULPHATE ALMUS| MULTIVITAMIN & MINERAL| MULTIVITAMIN & MINERAL| MULTIVITAMIN & MINERAL| TOPAMAX| TOPAMAX| TOPAMAX| TYLENOL| TYLENOL| TYLENOL| TYLENOL 8 HOUR| TYLENOL 8 HOUR| TYLENOL 8 HOUR| TYLENOL [PARACETAMOL]| TYLENOL [PARACETAMOL]| TYLENOL [PARACETAMOL]| TYLENOL [PARACETAMOL] |