ESSURE
Report
- Report Number
- 2951250-2019-02741
- Event Type
- Injury
- Date Received
- June 11, 2019
- Report Date
- July 24, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('MALPOSITION OF ESSUREDEVICE LOCATION OF DEVICE: NOT SURE IT PROBABLY WENT THROUGH THE RIGHT TUBE/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE:NOT SPECIFIED WENT THROUGH RIGHT TUBE,'), SALPINGITIS ('INFECTION (OTHER) DESCRIBE: RIGHT FALLOPIAN TUBE'), GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL),') AND PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY (NO COMPLICATIONS),') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 626209) 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 YOU UNDERGO AN ESSURE CONFIRMATION TEST? NO." AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED OFFENSIVE VAGINAL DISCHARGE AND LIVE BIRTH (B)(6) 2008,(B)(6) 2005, (B)(6) 1997, (B)(6) 1995). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PAIN,"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), DYSMENORRHOEA ("DYSMENORRHEA"), NAUSEA ("NAUSEA,"), RASH ("RASHES OR SKIN CONDITIONS"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), FATIGUE ("FATIGUE"), PYREXIA ("SHORT FEVER"), OROPHARYNGEAL PAIN ("SORE THROAT"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHE"), WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN,"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, SALPINGITIS, GENITAL HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, NAUSEA, RASH, FATIGUE, PYREXIA, WEIGHT INCREASED, OROPHARYNGEAL PAIN, VAGINAL DISCHARGE, MIGRAINE AND HEADACHE OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER AND ABDOMINAL PAIN HAD RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 6, PARA 5. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, OROPHARYNGEAL PAIN, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, PYREXIA, RASH, SALPINGITIS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AFTER PLACEMENT OF THE ESSURE TUBAL COILS THERE WERE 6 COILS EMITTING FROM THE LEFT OSTIA AND APPROXIMATELY 10 TO 12 FROM THE RIGHT OSTIA. HYSTEROSCOPIC PICTURES WERE TAKEN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUN-2019: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). 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 FALLOPIAN TUBE PERFORATION ('MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: NOT SURE IT PROBABLY WENT THROUGH THE RIGHT TUBE/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE:NOT SPECIFIED WENT THROUGH RIGHT TUBE,'), SALPINGITIS ('INFECTION (OTHER) DESCRIBE: RIGHT FALLOPIAN TUBE') AND PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY (NO COMPLICATIONS),') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 626209) 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 YOU UNDERGO AN ESSURE CONFIRMATION TEST? NO." AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED OFFENSIVE VAGINAL DISCHARGE AND LIVE BIRTH ((B)(6) 2008,(B)(6) 2005, (B)(6)1997, (B)(6) 1995). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN 2009, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN,"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL),"), PELVIC PAIN ("PAIN,"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), DYSMENORRHOEA ("DYSMENORRHEA"), NAUSEA ("NAUSEA,"), RASH ("RASHES OR SKIN CONDITIONS"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), PYREXIA ("SHORT FEVER"), OROPHARYNGEAL PAIN ("SORE THROAT"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHE") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, SALPINGITIS, PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, PELVIC PAIN, NAUSEA, RASH, FATIGUE, PYREXIA, WEIGHT INCREASED, OROPHARYNGEAL PAIN, MIGRAINE AND HEADACHE OUTCOME WAS UNKNOWN, THE VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, ABDOMINAL PAIN LOWER AND ABDOMINAL PAIN HAD RESOLVED AND THE DYSMENORRHOEA AND VAGINAL DISCHARGE WAS RESOLVING. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 6, PARA 5. 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 REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, OROPHARYNGEAL PAIN, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, PYREXIA, RASH, SALPINGITIS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AFTER PLACEMENT OF THE ESSURE TUBAL COILS THERE WERE 6 COILS EMITTING FROM THE LEFT OSTIA AND APPROXIMATELY 10 TO 12 FROM THE RIGHT OSTIA. HYSTEROSCOPIC PICTURES WERE TAKEN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS 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 FALLOPIAN TUBE PERFORATION ('MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: NOT SURE IT PROBABLY WENT THROUGH THE RIGHT TUBE/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE:NOT SPECIFIED WENT THROUGH RIGHT TUBE,'), SALPINGITIS ('INFECTION (OTHER) DESCRIBE: RIGHT FALLOPIAN TUBE'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY (NO COMPLICATIONS),') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL),') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 626209) 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 YOU UNDERGO AN ESSURE CONFIRMATION TEST? NO." AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED OFFENSIVE VAGINAL DISCHARGE AND LIVE BIRTH (B)(6)2008,(B)(6)2005, (B)(6)1997, (B)(6)1995). ON (B)(6)2008, THE PATIENT HAD ESSURE INSERTED. IN 2009, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN,"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PAIN,"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), DYSMENORRHOEA ("DYSMENORRHEA"), NAUSEA ("NAUSEA,"), RASH ("RASHES OR SKIN CONDITIONS"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), PYREXIA ("SHORT FEVER"), OROPHARYNGEAL PAIN ("SORE THROAT"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHE") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2015. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, SALPINGITIS, PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, PELVIC PAIN, NAUSEA, RASH, FATIGUE, PYREXIA, WEIGHT INCREASED, OROPHARYNGEAL PAIN, MIGRAINE AND HEADACHE OUTCOME WAS UNKNOWN, THE VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, ABDOMINAL PAIN LOWER AND ABDOMINAL PAIN HAD RESOLVED AND THE DYSMENORRHOEA AND VAGINAL DISCHARGE WAS RESOLVING. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 6, PARA 5. 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 REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, OROPHARYNGEAL PAIN, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, PYREXIA, RASH, SALPINGITIS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AFTER PLACEMENT OF THE ESSURE TUBAL COILS THERE WERE 6 COILS EMITTING FROM THE LEFT OSTIA AND APPROXIMATELY 10 TO 12 FROM THE RIGHT OSTIA. HYSTEROSCOPIC PICTURES WERE TAKEN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-DEC-2019: PFS RECEIVED- OUTCOME OF THE EVENT MENORRHAGIA, VAGINAL HAEMORRHAGE, APAREUNIA, DYSMENORRHEA AND VAGINAL DISCHARGE WERE UPDATED. 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 FALLOPIAN TUBE PERFORATION ('MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: NOT SURE IT PROBABLY WENT THROUGH THE RIGHT TUBE/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE:NOT SPECIFIED WENT THROUGH RIGHT TUBE,'), SALPINGITIS ('INFECTION (OTHER) DESCRIBE: RIGHT FALLOPIAN TUBE'), GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL),') AND PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY (NO COMPLICATIONS),') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 626209) 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? NO.". THE PATIENT'S MEDICAL HISTORY INCLUDED OFFENSIVE VAGINAL DISCHARGE AND LIVE BIRTH ((B)(6)). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), DYSMENORRHOEA ("DYSMENORRHEA"), NAUSEA ("NAUSEA,"), RASH ("RASHES OR SKIN CONDITIONS"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), FATIGUE ("FATIGUE"), PYREXIA ("SHORT FEVER"), PELVIC PAIN ("PAIN,"), OROPHARYNGEAL PAIN ("SORE THROAT"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHE"), WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN,"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE SALPINGITIS, GENITAL HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, NAUSEA, RASH, FATIGUE, PYREXIA, PELVIC PAIN, WEIGHT INCREASED, OROPHARYNGEAL PAIN, VAGINAL DISCHARGE, MIGRAINE AND HEADACHE OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER AND ABDOMINAL PAIN HAD RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 6, PARA 5. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, OROPHARYNGEAL PAIN, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, PYREXIA, RASH, SALPINGITIS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AFTER PLACEMENT OF THE ESSURE TUBAL COILS THERE WERE 6 COILS EMITTING FROM THE LEFT OSTIA AND APPROXIMATELY 10 TO 12 FROM THE RIGHT OSTIA. HYSTEROSCOPIC PICTURES WERE TAKEN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-JUN-2019: PFS AND MR RECEIVED : AKA NAME ADDED, REPORTER ADDED, LOT NUMBER ADDED, PATIENT DEMOGRAPHIC ADDED, ESSURE INSERTION DATE UPDATED AND REMOVAL DATE ADDED, PRODUCT INDICATION UPDATED. EVENT INJURY NOS IS REPLACED WITH FALLOPIAN TUBE PERFORATION. CASE BECOME VALID. EVENTS ADDED- FALLOPIAN TUBE PERFORATION, PELVIC PAIN, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), DYSMENORRHEA (CRAMPING), SALPINGITIS, FATIGUE, VAGINAL DISCHARGE, WEIGHT GAIN, FEVER, ABNORMAL BLEEDING (GENERAL), APAREUNIA, OROPHARYNGEAL PAIN, ABDOMINAL PAIN, , DEVICE MONITORING PROCEDURE NOT PERFORMED, NAUSEA, PREGNANCY WITH CONTRACEPTIVE DEVICE, DEVICE INEFFECTIVE, RASH. EVENTS SEVERITY AND MEDICAL HISTORY 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-CONFORMANCE'S DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 481194 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 626209 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |