ESSURE
Report
- Report Number
- 2951250-2017-02767
- Event Type
- Injury
- Date Received
- August 18, 2017
- Date of Event
- June 22, 2016
- Report Date
- April 4, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
SPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PREGNANCY WITH CONTRACEPTIVE DEVICE ("POST IMPLANT PREGNANCY") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 654836) 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" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE. CONCURRENT CONDITIONS INCLUDED VAGINAL BLEEDING. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN JULY 2010, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"), WEIGHT INCREASED ("WEGHIT GAIN") AND ANXIETY ("METAL ANGUISH"). IN AUGUST 2015, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN"). IN APRIL 2016, 6 YEARS 5 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (C-SECTION PERFORMED BECAUSE HER UTERUS RUPTURED WHILE SHE WAS HAVING CONTRACTIONS). AT THE TIME OF THE REPORT, THE PREGNANCY WITH CONTRACEPTIVE DEVICE, DEPRESSION, WEIGHT INCREASED, ANXIETY AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THIS CASE 2017-141221 REFERS TO SECOND PREGNANCY(POST IMPLANT PREGNANCY). FOR THE FIRST PREGNANCY (ECTOPIC) REFER TO CASE 2017-140455. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-AUG-2018: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL PROBLEM ) 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 PREGNANCY WITH CONTRACEPTIVE DEVICE ("POST IMPLANT PREGNANCY / PREGNANCY (WITH COMPLICATIONS)") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 654836) 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 YOU UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, MULTIGRAVIDA AND PARITY 5 (B)(6)1997, (B)(6)2003, (B)(6)2004, (B)(6)2010, (B)(6)2017). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IUD AND DEPO- PROVERA. CONCURRENT CONDITIONS INCLUDED VAGINAL BLEEDING AND OBESITY. CONCOMITANT PRODUCTS INCLUDED FERROUS SULFATE FROM (B)(6)2010 TO (B)(6)2017, IBUPROFEN SINCE (B)(6)2010, NSAIDS SINCE (B)(6)2010 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6)2010. IN 2010, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"). IN (B)(6)2010, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/WEIGHT GAIN/LOSS SPECIFY: GAIN "). ON (B)(6)2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2010, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN/PELVIC PAIN/PELVIC AREA PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MIGRAINE ("MIGRAINES / HEADACHES"), HEADACHE ("MIGRAINES / HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), ABDOMINAL PAIN ("ABDOMINAL PAIN/ABDOMINAL AREA PAIN") AND ANAEMIA ("BLOOD OR HEART DISORDER/CONDITION TYPE: ANEMIA"). IN (B)(6)2010, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION/PSYCHOLOGICAL OR PSYCHIATRIC CONDITION: DEPRESSION") AND ANXIETY ("METAL ANGUISH/PSYCHOLOGICAL OR PSYCHIATRIC CONDITION: ANXIETY"). IN 2016, THE PATIENT EXPERIENCED HOT FLUSH ("HORMONAL CHANGES DESCRIBE: HOT FLASH") AND FEELING COLD ("HORMONAL CHANGES DESCRIBE: HOT FLASH"). ON (B)(6)2016, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 5 YEARS 11 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND EXPERIENCED BACK PAIN ("LOWER BACK PAIN"). THE PATIENT WAS TREATED WITH IBUPROFEN AND SURGERY (C SECTION). AT THE TIME OF THE REPORT, THE PREGNANCY WITH CONTRACEPTIVE DEVICE, DEPRESSION, WEIGHT INCREASED, ANXIETY, PELVIC PAIN, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, MIGRAINE, HEADACHE, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, ABDOMINAL PAIN, HOT FLUSH, FEELING COLD, BACK PAIN AND ANAEMIA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: PROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANAEMIA, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING COLD, FEMALE SEXUAL DYSFUNCTION, HEADACHE, HORMONE LEVEL ABNORMAL, HOT FLUSH, MENORRHAGIA, MIGRAINE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THIS CASE (B)(4) REFERS TO SECOND PREGNANCY(POST IMPLANT PREGNANCY). FOR THE FIRST PREGNANCY (ECTOPIC) REFER TO CASE (B)(4). DISCREPANCY IN ESSURE CONFIRMATION TEST. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 31 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2010: RESULTS: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-MAR-2019: NEW PFS RECEIVED. NEW EVENT- BLOOD OR HEART DISORDER/CONDITION TYPE: ANEMIA ADDED. CONCOMITANT AND HISTORICAL DRUGS ADDED. ONSET DATES FOR EVENTS WERE UPDATED. INCIDENT: 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PREGNANCY WITH CONTRACEPTIVE DEVICE ("POST IMPLANT PREGNANCY / PREGNANCY (WITH COMPLICATIONS)") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 654836) 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 YOU UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, MULTIGRAVIDA AND PARITY 5 ((B)(6) 1997, (B)(6) 2003, (B)(6) 2004, (B)(6) 2010, (B)(6) 2017). CONCURRENT CONDITIONS INCLUDED VAGINAL BLEEDING AND OBESITY. CONCOMITANT PRODUCTS INCLUDED FERROUS SULFATE, IBUPROFEN SINCE 2010 AND PARACETAMOL (ACETAMINOPHEN) SINCE 2010. IN 2010, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND ABDOMINAL PAIN ("ABDOMINAL PAIN/ABDOMINAL AREA PAIN"). IN (B)(6) 2010, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION/PSYCHOLOGICAL OR PSYCHIATRIC CONDITION: DEPRESSION") AND ANXIETY ("METAL ANGUISH/PSYCHOLOGICAL OR PSYCHIATRIC CONDITION: ANXIETY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEGHIT GAIN/WEIGHT GAIN/LOSS SPECIFY: GAIN "). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES"), HEADACHE ("MIGRAINES / HEADACHES") AND FATIGUE ("FATIGUE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN/PELVIC PAIN/PELVIC AREA PAIN"). IN (B)(6) 2016, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 6 YEARS 5 MONTHS AFTER INSERTION OF ESSURE. IN 2016, THE PATIENT EXPERIENCED HOT FLUSH ("HORMONAL CHANGES DESCRIBE: HOT FLASH") AND FEELING COLD ("HORMONAL CHANGES DESCRIBE: HOT FLASH"). ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND EXPERIENCED BACK PAIN ("LOWER BACK PAIN"). THE PATIENT WAS TREATED WITH IBUPROFEN AND SURGERY (C-SECTION PERFORMED BECAUSE HER UTERUS RUPTURED WHILE SHE WAS HAVING CONTRACTIONS). AT THE TIME OF THE REPORT, THE PREGNANCY WITH CONTRACEPTIVE DEVICE, DEPRESSION, WEIGHT INCREASED, ANXIETY, PELVIC PAIN, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, MIGRAINE, HEADACHE, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, ABDOMINAL PAIN, HOT FLUSH, FEELING COLD AND BACK PAIN OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: PROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING COLD, FEMALE SEXUAL DYSFUNCTION, HEADACHE, HORMONE LEVEL ABNORMAL, HOT FLUSH, MENORRHAGIA, MIGRAINE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THIS CASE (B)(4) REFERS TO SECOND PREGNANCY(POST IMPLANT PREGNANCY). FOR THE FIRST PREGNANCY (ECTOPIC) REFER TO CASE (B)(4). DISCREPANCY IN ESSURE CONFIRMATION TEST. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 33.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2010: RESULTS: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-DEC-2018: PFS RECEIVED. EVENTS PER PFS: HORMONAL CHANGES, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), PSYCHOLOGICAL OR PSYCHIATRIC CONDITION: DEPRESSION, MENTAL ANGUISH, MIGRAINES / HEADACHES, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FATIGUE WERE ADDED. INCIDENT 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT
THIS PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PREGNANCY WITH CONTRACEPTIVE DEVICE ("POST IMPLANT PREGNANCY") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 654836) 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" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE. CONCURRENT CONDITIONS INCLUDED VAGINAL BLEEDING. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2010, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"), WEIGHT INCREASED ("WEIGHT GAIN") AND ANXIETY ("METAL ANGUISH"). IN (B)(6) 2015, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN"). IN (B)(6) 2016, 6 YEARS 5 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (C-SECTION PERFORMED BECAUSE HER UTERUS RUPTURED WHILE SHE WAS HAVING CONTRACTIONS). AT THE TIME OF THE REPORT, THE PREGNANCY WITH CONTRACEPTIVE DEVICE, DEPRESSION, WEIGHT INCREASED, ANXIETY AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THIS CASE (B)(4) REFERS TO SECOND PREGNANCY(POST IMPLANT PREGNANCY). FOR THE FIRST PREGNANCY (ECTOPIC) REFER TO CASE (B)(4). MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET RECEIVED: REPORTERS AND EVENTS (DEPRESSION, MENTAL ANGUISH, DID YOU UNDERGO AN ESSURE CONFIRMATION TEST, PELVIC PAIN, WEIGHT GAIN) 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 PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PREGNANCY WITH CONTRACEPTIVE DEVICE ("POST IMPLANT PREGNANCY") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, 6 YEARS 5 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (C-SECTION PERFORMED BECAUSE HER UTERUS RUPTURED WHILE SHE WAS HAVING CONTRACTIONS). AT THE TIME OF THE REPORT, THE PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THIS CASE (B)(4) REFERS TO SECOND PREGNANCY(POST IMPLANT PREGNANCY). FOR THE FIRST PREGNANCY (ECTOPIC) REFER TO CASE (B)(4). MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-AUG-2017: IN THE PATIENT TAB OTHER RELEVANT HISTORY "PT ECTOPIC PREGNANCY AMENDED TO ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE AND REPORTER CAUSALITY COMMENT AMENDED TO "THIS CASE (B)(4) REFERS TO SECOND PREGNANCY (POST IMPLANT PREGNANCY). FOR THE FIRST PREGNANCY (ECTOPIC) REFER TO CASE (B)(4)". 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.
THIS PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PREGNANCY WITH CONTRACEPTIVE DEVICE ("POST IMPLANT PREGNANCY") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ECTOPIC PREGNANCY. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, 6 YEARS 5 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (C-SECTION PERFORMED BECAUSE HER UTERUS RUPTURED WHILE SHE WAS HAVING CONTRACTIONS). AT THE TIME OF THE REPORT, THE PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THIS CASE (B)(4) REFERS TO FIRST PREGNANCY(POST IMPLANT PREGNANCY). FOR THE SECOND PREGNANCY (ECTOPIC) REFER TO CASE (B)(4). 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 |
|---|---|---|---|---|---|---|---|
| 584695 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 654836 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| FERROUS SULFATE| FERROUS SULFATE| IBUPROFEN| IBUPROFEN| NSAIDS |