ESSURE
Report
- Report Number
- 2951250-2017-07513
- Event Type
- Injury
- Date Received
- November 23, 2017
- Date of Event
- January 1, 2012
- Report Date
- October 23, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ('PERFORATION'), FALLOPIAN TUBE PERFORATION ('PERFORATION'), MENORRHAGIA ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841532) 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 "PLAINTIFF DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED VAGINAL DELIVERY IN (B)(6) 2011, HEPATIC CYST, ENDOMETRIOSIS, CHRONIC CERVICITIS AND DYSMENORRHEA. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSPAREUNIA ("DYSPAREUNIA/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND PELVIC PAIN ("PAIN/PAIN"). THE PATIENT WAS TREATED WITH SURGERY (NOVASURE ENDOMETRIAL ABLATION WITH HYSTEROSCOPY AND TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, DYSPAREUNIA AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, UTERINE PERFORATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT NEED FOR ADDITIONAL SURGERY. THE PATIENT TOLERATED THE PROCEDURE WELL. INSERTION DETAILS : THERE WERE TWO COILS NOTED ON THE RIGHT SICK PROTRUDING INTO THE UTERUS. THERE WERE NO COILS NOTED ON THE LEFT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON AN UNKNOWN DATE: PATIENT APPARENTLY HAD A NEGATIVE PREGNANCY TEST.. ULTRASOUND PELVIS - ON (B)(6) 2015: THERE IS BLOOD LAYERING IN THE PELVIS. IT IS DIFFICULT TO DISTINGUISH LEFT OVARY FROM TUBE FROM BLOOD THE LEFT OVARY IS NEVER WELL IDENTIFIED.THERE ARE ESSURE TUBES PRESENT BILATERALLY WHICH ARE BEST SEEN ON THE SCALP TOPOGRAM.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: DYSPAREUNIA, PELVIC PAIN, VAGINAL BLEEDING, MENORRHAGIA. 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. 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 UTERINE PERFORATION ('PERFORATION'), FALLOPIAN TUBE PERFORATION ('PERFORATION'), MENORRHAGIA ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841532) 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 "PLAINTIFF DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED VAGINAL DELIVERY IN (B)(6) 2011, HEPATIC CYST, ENDOMETRIOSIS, CHRONIC CERVICITIS AND DYSMENORRHEA. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSPAREUNIA ("DYSPAREUNIA/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND PELVIC PAIN ("PAIN/PAIN"). THE PATIENT WAS TREATED WITH SURGERY (NOVASURE ENDOMETRIAL ABLATION WITH HYSTEROSCOPY AND TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, DYSPAREUNIA AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, UTERINE PERFORATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT NEED FOR ADDITIONAL SURGERY. THE PATIENT TOLERATED THE PROCEDURE WELL. INSERTION DETAILS : THERE WERE TWO COILS NOTED ON THE RIGHT SICK PROTRUDING INTO THE UTERUS. THERE WERE NO COILS NOTED ON THE LEFT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON AN UNKNOWN DATE: PATIENT APPARENTLY HAD A NEGATIVE PREGNANCY TEST.. ULTRASOUND PELVIS - ON (B)(6) 2015: THERE IS BLOOD LAYERING IN THE PELVIS. IT IS DIFFICULT TO DISTINGUISH LEFT OVARY FROM TUBE FROM BLOOD THE LEFT OVARY IS NEVER WELL IDENTIFIED. THERE ARE ESSURE TUBES PRESENT BILATERALLY WHICH ARE BEST SEEN ON THE SCALP TOPOGRAM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: DYSPAREUNIA, PELVIC PAIN, VAGINAL BLEEDING, MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-JUN-2019: PFS AND MR RECEIVED : EVENTS PER PFS: ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) AND PLAINTIFF DID NOT UNDERWENT ESSURE CONFIRMATION TEST. EVENT OF "PERFORATION" AMENDED TO UTERINE PERFORATION AND FALLOPIAN TUBE PERFORATION. LOT NUMBER WAS ADDED. LABORATORY DATA WAS ADDED. ESSURE REMOVAL PROCEDURE WAS ADDED. PATIENT'S MEDICAL HISTORY WAS 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 UTERINE PERFORATION ('PERFORATION'), FALLOPIAN TUBE PERFORATION ('PERFORATION'), MENORRHAGIA ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING/ BLEEDING') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841532, 841632) 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 "PLAINTIFF DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED VAGINAL DELIVERY IN (B)(6)2011, HEPATIC CYST, ENDOMETRIOSIS, CHRONIC CERVICITIS AND DYSMENORRHEA. CONCURRENT CONDITIONS INCLUDED UTERINE ENLARGEMENT, VAGINAL PAIN, VULVOVAGINAL PAIN AND ADNEXA UTERI TENDERNESS. ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSPAREUNIA ("DYSPAREUNIA/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), PELVIC PAIN ("PAIN/PAIN") AND URINARY TRACT DISORDER ("URINARY PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (NOVASURE ENDOMETRIAL ABLATION WITH HYSTEROSCOPY AND TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, DYSPAREUNIA, PELVIC PAIN AND URINARY TRACT DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, URINARY TRACT DISORDER, UTERINE PERFORATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT NEED FOR ADDITIONAL SURGERY. THE PATIENT TOLERATED THE PROCEDURE WELL. INSERTION DETAILS : THERE WERE TWO COILS NOTED ON THE RIGHT SICK PROTRUDING INTO THE UTERUS. THERE WERE NO COILS NOTED ON THE LEFT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON AN UNKNOWN DATE: PATIENT APPARENTLY HAD A NEGATIVE PREGNANCY TEST.. ULTRASOUND PELVIS - ON (B)(6)2015: THERE IS BLOOD LAYERING IN THE PELVIS. IT IS DIFFICULT TO DISTINGUISH LEFT OVARY FROM TUBE FROM BLOOD THE LEFT OVARY IS NEVER WELL IDENTIFIED. THERE ARE ESSURE TUBES PRESENT BILATERALLY WHICH ARE BEST SEEN ON THE SCALP TOPOGRAM.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: DYSPAREUNIA, PELVIC PAIN, VAGINAL BLEEDING, MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-AUG-2019: PFS RECEIVED. REPORTER INFORMATION UPDATED. LOT NUMBER ADDED. NEW EVENT: URINARY PROBLEMS WAS ADDED. 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-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 UTERINE PERFORATION ('PERFORATION'), FALLOPIAN TUBE PERFORATION ('PERFORATION'), MENORRHAGIA ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING/ BLEEDING') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841532,841632-NOT VALID) 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 "PLAINTIFF DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED VAGINAL DELIVERY IN (B)(6)2011, HEPATIC CYST, ENDOMETRIOSIS, CHRONIC CERVICITIS AND DYSMENORRHEA. CONCURRENT CONDITIONS INCLUDED UTERINE ENLARGEMENT, VAGINAL PAIN, VULVOVAGINAL PAIN AND ADNEXA UTERI TENDERNESS. ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSPAREUNIA ("DYSPAREUNIA/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), PELVIC PAIN ("PAIN/PAIN") AND URINARY TRACT DISORDER ("URINARY PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (NOVASURE ENDOMETRIAL ABLATION WITH HYSTEROSCOPY AND TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, DYSPAREUNIA, PELVIC PAIN AND URINARY TRACT DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, URINARY TRACT DISORDER, UTERINE PERFORATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT NEED FOR ADDITIONAL SURGERY. THE PATIENT TOLERATED THE PROCEDURE WELL. INSERTION DETAILS : THERE WERE TWO COILS NOTED ON THE RIGHT SICK PROTRUDING INTO THE UTERUS. THERE WERE NO COILS NOTED ON THE LEFT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON AN UNKNOWN DATE: PATIENT APPARENTLY HAD A NEGATIVE PREGNANCY TEST.. ULTRASOUND PELVIS - ON (B)(6)2015: THERE IS BLOOD LAYERING IN THE PELVIS. IT IS DIFFICULT TO DISTINGUISH LEFT OVARY FROM TUBE FROM BLOOD THE LEFT OVARY IS NEVER WELL IDENTIFIED. THERE ARE ESSURE TUBES PRESENT BILATERALLY WHICH ARE BEST SEEN ON THE SCALP TOPOGRAM.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: DYSPAREUNIA, PELVIC PAIN, VAGINAL BLEEDING, MENORRHAGIA. LOT NUMBER 841632 IS NOT VALID. LOT NUMBER: 841532, MANUFACTURE DATE: 2011-03, EXPIRATION DATE: 2014-03. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-AUG-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 UTERINE PERFORATION ('PERFORATION'), FALLOPIAN TUBE PERFORATION ('PERFORATION'), MENORRHAGIA ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING/ BLEEDING') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841532,841632-NOT VALID) 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 "PLAINTIFF DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED VAGINAL DELIVERY IN (B)(6) 2011, HEPATIC CYST, ENDOMETRIOSIS, CHRONIC CERVICITIS, DYSMENORRHEA AND PARITY 3 ((B)(6) 2003, (B)(6) 2005, (B)(6) 2011). CONCURRENT CONDITIONS INCLUDED UTERINE ENLARGEMENT, VAGINAL PAIN, VULVOVAGINAL PAIN AND ADNEXA UTERI TENDERNESS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSPAREUNIA ("DYSPAREUNIA/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("PAIN/PAIN/ABDOMEN PAIN") AND BACK PAIN ("PAIN/PAIN/BACK PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URINARY TRACT DISORDER ("URINARY PROBLEMS"), HYPERTENSION ("BLOOD OR HEART DISORDER/CONDITION ¿ HYPERTENSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS ¿ ANXIETY"). THE PATIENT WAS TREATED WITH SURGERY (NOVASURE ENDOMETRIAL ABLATION WITH HYSTEROSCOPY/UNDERWENT ABLATION ON (B)(6) 2014, TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY AND TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY/HYSTERECTOMY(FULL)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, DYSPAREUNIA, URINARY TRACT DISORDER, HYPERTENSION AND ANXIETY OUTCOME WAS UNKNOWN AND THE MENORRHAGIA, VAGINAL HAEMORRHAGE, ABDOMINAL PAIN AND BACK PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, HYPERTENSION, MENORRHAGIA, URINARY TRACT DISORDER, UTERINE PERFORATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT NEED FOR ADDITIONAL SURGERY. THE PATIENT TOLERATED THE PROCEDURE WELL. INSERTION DETAILS : THERE WERE TWO COILS NOTED ON THE RIGHT SICK PROTRUDING INTO THE UTERUS. THERE WERE NO COILS NOTED ON THE LEFT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON AN UNKNOWN DATE: PATIENT APPARENTLY HAD A NEGATIVE PREGNANCY TEST.. ULTRASOUND PELVIS - ON (B)(6) 2015: THERE IS BLOOD LAYERING IN THE PELVIS. IT IS DIFFICULT TO DISTINGUISH LEFT OVARY FROM TUBE FROM BLOOD THE LEFT OVARY IS NEVER WELL IDENTIFIED. THERE ARE ESSURE TUBES PRESENT BILATERALLY WHICH ARE BEST SEEN ON THE SCALP TOPOGRAM.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: DYSPAREUNIA, PELVIC PAIN, VAGINAL BLEEDING, MENORRHAGIA. LOT NUMBER 841632 IS NOT VALID. LOT NUMBER: 841532, MANUFACTURE DATE: 2011-03, EXPIRATION DATE: 2014-03. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-OCT-2019: PFS RECEIVED. REPORTER INFORMATION, MEDICAL HISTORY ADDED. EVENT OUTCOME UPDATED. EVENT PAIN WAS UPDATED TO BACK AND ABDOMEN PAIN. EVENTS : BLOOD OR HEART DISORDER/CONDITION ¿ HYPERTENSION, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS ¿ ANXIETY ADDED. ON 7-OCT-2019: PFS RECEIVED. NO NEW INFORMATION 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-CONFORMANT 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 PERFORATION ("PERFORATION") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA") AND PELVIC PAIN ("PAIN"). THE PATIENT WAS TREATED WITH SURGERY TO REMOVE THE ESSURE IMPLANT ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PERFORATION, GENITAL HAEMORRHAGE, DYSPAREUNIA AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSPAREUNIA, GENITAL HAEMORRHAGE, PELVIC PAIN AND PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT NEED FOR ADDITIONAL SURGERY. 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 |
|---|---|---|---|---|---|---|---|
| 834931 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841532,841632-NOT VALID |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other| R |