ESSURE
Report
- Report Number
- 2951250-2019-00179
- Event Type
- Injury
- Date Received
- January 7, 2019
- Date of Event
- July 1, 2012
- Report Date
- May 25, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/PAIN') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MIGRAINE AND CULDOPLASTY. CONCURRENT CONDITIONS INCLUDED ENDOCERVICITIS, ADENOMYOSIS, INTRAMURAL LEIOMYOMA OF UTERUS, PARATUBAL CYST, VAGINAL PROLAPSE, HYDROSALPINX, PARATUBAL CYST, INTRAMURAL LEIOMYOMA OF UTERUS AND ADENOMYOSIS. CONCOMITANT PRODUCTS INCLUDED DIAZEPAM (VALIUM), ETHINYLESTRADIOL;ETONOGESTREL (NUVARING)(B)(6) 2012 TO (B)(6) 2012, HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), IBUPROFEN, KETOROLAC TROMETHAMINE (TORADOL), MEPIVACAINE HYDROCHLORIDE (CARBOCAINE), NSAIDS FROM JUNE 2012 TO DECEMBER 2016 AND PARACETAMOL (ACETAMINOPHEN) FROM JUNE 2012 TO DECEMBER 2016. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), 14 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2013, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUATION ISSUES."). THE PATIENT WAS TREATED WITH SURGERY (TRANSVAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY,MCCALL CULDOPLASTY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE MENSTRUAL DISORDER, DEPRESSION, ANXIETY, DYSMENORRHOEA AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE WERE 4 TRAILING COILS IN IN LEFT AND 4 ON RIGHT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. X-RAY - ON (B)(6) 2012: BLOCKED FALLOPIAN TUBES WITH NO PERITONEAL SPILL.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORD: PELVIC PAIN, DYSMENORRHEA AND DYSPAREUNIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-JUL-2019: PFS RECEIVED : PREVIOUSLY REPORTED EVENT "INJURY " REPLACED WITH NEW EVENT .NEW EVENTS ADDED : DEPRESSION, MENTAL ANGUISH, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE).LOT NUMBER RECEIVED, EVENT OUTCOME, REPORTER INFORMATION, CONCOMITANT DRUGS, PATIENT HISTORY AND LAB DATA 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/PAIN') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MIGRAINE AND CULDOPLASTY. CONCURRENT CONDITIONS INCLUDED ENDOCERVICITIS, ADENOMYOSIS, INTRAMURAL LEIOMYOMA OF UTERUS, PARATUBAL CYST, VAGINAL PROLAPSE, HYDROSALPINX, PARATUBAL CYST, INTRAMURAL LEIOMYOMA OF UTERUS AND ADENOMYOSIS. CONCOMITANT PRODUCTS INCLUDED DIAZEPAM (VALIUM), ETHINYLESTRADIOL;ETONOGESTREL (NUVARING) (B)(6) 2012 TO SEPTEMBER 2012, HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), IBUPROFEN, KETOROLAC TROMETHAMINE (TORADOL), MEPIVACAINE HYDROCHLORIDE (CARBOCAINE), NSAIDS FROM JUNE 2012 TO DECEMBER 2016 AND PARACETAMOL (ACETAMINOPHEN) FROM JUNE 2012 TO DECEMBER 2016. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), 14 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2013, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUATION ISSUES."). THE PATIENT WAS TREATED WITH SURGERY (TRANSVAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY,MCCALL CULDOPLASTY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE MENSTRUAL DISORDER, DEPRESSION, ANXIETY, DYSMENORRHOEA AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE WERE 4 TRAILING COILS IN IN LEFT AND 4 ON RIGHT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. X-RAY - ON (B)(6) 2012: BLOCKED FALLOPIAN TUBES WITH NO PERITONEAL SPILL.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORD: PELVIC PAIN, DYSMENORRHEA AND DYSPAREUNIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 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-CONFORMANCE'S 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 PELVIC PAIN ('PELVIC PAIN/PAIN') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MIGRAINE AND CULDOPLASTY. CONCURRENT CONDITIONS INCLUDED ENDOCERVICITIS, ADENOMYOSIS, INTRAMURAL LEIOMYOMA OF UTERUS, PARATUBAL CYST, VAGINAL PROLAPSE, HYDROSALPINX, PARATUBAL CYST, INTRAMURAL LEIOMYOMA OF UTERUS AND ADENOMYOSIS. CONCOMITANT PRODUCTS INCLUDED DIAZEPAM (VALIUM), ETHINYLESTRADIOL;ETONOGESTREL (NUVARING) (B)(6) 2012, HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), IBUPROFEN, KETOROLAC TROMETHAMINE (TORADOL), MEPIVACAINE HYDROCHLORIDE (CARBOCAINE), NSAIDS FROM (B)(6) 2012 TO (B)(6) 2016 AND PARACETAMOL (ACETAMINOPHEN) FROM (B)(6) 2012 TO (B)(6) 2016. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), 14 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"). IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("MENORRHAGIA(ABNORMAL BLEEDING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES."). THE PATIENT WAS TREATED WITH SURGERY (TRANSVAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY, MCCALL CULDOPLASTY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED AND THE DYSMENORRHOEA, DYSPAREUNIA, MENSTRUAL DISORDER, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE WERE 4 TRAILING COILS IN LEFT AND 4 ON RIGHT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. X-RAY - ON (B)(6) 2012: BLOCKED FALLOPIAN TUBES WITH NO PERITONEAL SPILL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED: OUTCOME OF THE PREVIOUSLY REPORTED EVENT- VAGINAL HAEMORRHAGE, MENORRHAGIA WERE UPDATED, REPORTER 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/PAIN') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MIGRAINE AND CULDOPLASTY. CONCURRENT CONDITIONS INCLUDED ENDOCERVICITIS, ADENOMYOSIS, INTRAMURAL LEIOMYOMA OF UTERUS, PARATUBAL CYST, VAGINAL PROLAPSE, HYDROSALPINX, PARATUBAL CYST, INTRAMURAL LEIOMYOMA OF UTERUS AND ADENOMYOSIS. CONCOMITANT PRODUCTS INCLUDED DIAZEPAM (VALIUM), ETHINYLESTRADIOL;ETONOGESTREL (NUVARING) (B)(6) 2012 TO (B)(6) 2012, HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), IBUPROFEN, KETOROLAC TROMETHAMINE (TORADOL), MEPIVACAINE HYDROCHLORIDE (CARBOCAINE), NSAIDS FROM JUNE 2012 TO DECEMBER 2016 AND PARACETAMOL (ACETAMINOPHEN) FROM (B)(6) 2012 TO DECEMBER 2016. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), 14 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"). IN JULY 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("MENORRHAGIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES."). THE PATIENT WAS TREATED WITH SURGERY (TRANSVAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY,MCCALL CULDOPLASTY). ESSURE WAS REMOVED ON 16-DEC-2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE AND ABDOMINAL PAIN HAD RESOLVED AND THE DYSMENORRHOEA, DYSPAREUNIA, MENSTRUAL DISORDER, DEPRESSION, ANXIETY, VAGINAL HAEMORRHAGE AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE WERE 4 TRAILING COILS IN IN LEFT AND 4 ON RIGHT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON 14-SEP-2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. X-RAY - ON 14-SEP-2012: BLOCKED FALLOPIAN TUBES WITH NO PERITONEAL SPILL.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORD: PELVIC PAIN, DYSMENORRHEA AND DYSPAREUNIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PLAINTIFF FACT SHEET RECEIVED. EVENTS: ABNORMAL BLEEDING (VAGINAL), MENORRHAGIA WERE NEWLY ADDED. WE RECEIVED A LOT NUMBER. 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 PELVIC PAIN ('PELVIC PAIN/PAIN') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MIGRAINE AND CULDOPLASTY. CONCURRENT CONDITIONS INCLUDED ENDOCERVICITIS, ADENOMYOSIS, INTRAMURAL LEIOMYOMA OF UTERUS, PARATUBAL CYST, VAGINAL PROLAPSE, HYDROSALPINX, PARATUBAL CYST, INTRAMURAL LEIOMYOMA OF UTERUS AND ADENOMYOSIS. CONCOMITANT PRODUCTS INCLUDED DIAZEPAM (VALIUM), ETHINYLESTRADIOL;ETONOGESTREL (NUVARING)31-MAY-2012 TO SEPTEMBER 2012, HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), IBUPROFEN, KETOROLAC TROMETHAMINE (TORADOL), MEPIVACAINE HYDROCHLORIDE (CARBOCAINE), NSAIDS FROM JUNE 2012 TO DECEMBER 2016 AND PARACETAMOL (ACETAMINOPHEN) FROM JUNE 2012 TO DECEMBER 2016. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), 14 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2013, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES."). THE PATIENT WAS TREATED WITH SURGERY (TRANSVAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY,MCCALL CULDOPLASTY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE AND ABDOMINAL PAIN HAD RESOLVED AND THE DYSMENORRHOEA, DYSPAREUNIA, MENSTRUAL DISORDER, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE WERE 4 TRAILING COILS IN IN LEFT AND 4 ON RIGHT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. X-RAY - ON (B)(6) 2012: BLOCKED FALLOPIAN TUBES WITH NO PERITONEAL SPILL.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORD: PELVIC PAIN, DYSMENORRHEA AND DYSPAREUNIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-SEP-2019: PFS RECEIVED: NEW EVENTS ABDOMINAL PAIN, GENERAL ABNORMAL BLEEDING WAS ADDED AND EVENT PELVIC PAIN OUTCOME 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 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 PELVIC PAIN ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES."). THE PATIENT WAS TREATED WITH SURGERY (TRANSVAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY,MCCALL CULDOPLASTY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17717 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 922613 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| CARBOCAINE| CARBOCAINE| CARBOCAINE| CARBOCAINE| CARBOCAINE| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| NSAIDS| NSAIDS| NSAIDS| NSAIDS| NSAIDS| NUVARING| NUVARING| NUVARING| NUVARING| NUVARING| TORADOL| TORADOL| TORADOL| TORADOL| TORADOL| VALIUM| VALIUM| VALIUM| VALIUM| VALIUM| VICODIN| VICODIN| VICODIN| VICODIN| VICODIN |