ESSURE
Report
- Report Number
- 2951250-2017-06272
- Event Type
- Injury
- Date Received
- November 8, 2017
- Report Date
- October 18, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822375) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY NO". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ADENOMYOSIS, VAGINAL DISCHARGE, BLOODY DISCHARGE, UTERINE TENDERNESS, ENDOMETRIOSIS, LOWER ABDOMINAL PAIN, UTERINE BLEEDING, ALLERGY TO VACCINE, ANAPHYLACTIC SHOCK DUE TO EGGS, LATEX ALLERGY, BONE MARROW TRANSPLANT, VOMITING AND PARATUBAL CYST. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN DIAGNOSTIC: CHRONIC PELVIC PAIN"). ON (B)(6) 2012, 1 YEAR 7 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND UTERINE HAEMORRHAGE ("POOLED BLOOD IN MYOMETRIUM"). ON (B)(6) 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), INFLAMMATION ("INFLAMMATION"), BACK PAIN ("SEVERE BACK PAIN") AND ADVERSE EVENT ("ABNORMAL SYMPTOMS"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY AND/OR HYSTERECTOMY TO REMOVE THE ESSURE ON (B)(6) 2012). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, INFLAMMATION, BACK PAIN, ADVERSE EVENT, VAGINAL HAEMORRHAGE, MENORRHAGIA, NAUSEA AND UTERINE HAEMORRHAGE OUTCOME WAS UNKNOWN AND THE PELVIC PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADVERSE EVENT, BACK PAIN, INFLAMMATION, MENORRHAGIA, NAUSEA, PELVIC PAIN, UTERINE HAEMORRHAGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF WAS USED CONDOMS FROM (B)(6) 2011 TO (B)(6) 2011 TO PREVENT PREGNANCY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND PELVIS - ON (B)(6) 2012: UTERUS SIZE NORMAL, ECHOGENICITY PLAINTIFF HAD DONE US TRANS-ABDOMINAL AND ENDO VAGINAL PELVIS ULTRASOUND. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: ABDOMINAL PAIN, PELVIC PAIN, BACK PAIN, MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-NOV-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED: REPORTERS ADDED. DEMOGRAPHIC CONDITIONS ADDED. LOT NUMBER ADDED. DEVICE REMOVAL DATE UPDATED. EVENTS: ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), NAUSEA, PELVIC PAIN, HEMATOMETRA. EVENT ONSET DATE AND OUTCOME WERE UPDATED. CONCOMITANT CONDITIONS ADDED. LAB DATA ADDED. AUTO-NARRATIVE SUPPLEMENT ADDED. REPORTER CAUSALITY COMMENT 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 ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822375) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY NO". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ADENOMYOSIS, VAGINAL DISCHARGE, HAEMORRHAGE NOS, UTERINE TENDERNESS, ENDOMETRIOSIS, LOWER ABDOMINAL PAIN, UTERINE BLEEDING, ALLERGY TO VACCINE, ANAPHYLACTIC SHOCK DUE TO EGGS, ANAPHYLACTIC REACTION, BONE MARROW TRANSPLANT, VOMITING AND PARATUBAL CYST. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN DIAGNOSTIC: CHRONIC PELVIC PAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND UTERINE HAEMORRHAGE ("POOLED BLOOD IN MYOMETRIUM"), 1 YEAR 7 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), INFLAMMATION ("INFLAMMATION"), BACK PAIN ("SEVERE BACK PAIN") AND ADVERSE EVENT ("ABNORMAL SYMPTOMS"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY AND/OR HYSTERECTOMY TO REMOVE THE ESSURE ON (B)(6)2012). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, INFLAMMATION, BACK PAIN, ADVERSE EVENT, VAGINAL HAEMORRHAGE, MENORRHAGIA, NAUSEA AND UTERINE HAEMORRHAGE OUTCOME WAS UNKNOWN AND THE PELVIC PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADVERSE EVENT, BACK PAIN, INFLAMMATION, MENORRHAGIA, NAUSEA, PELVIC PAIN, UTERINE HAEMORRHAGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF WAS USING CONDOMS FROM (B)(6) 2011 TO (B)(6) 2011 TO PREVENT PREGNANCY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND PELVIS - ON (B)(6) 2012: RESULTS: UTERUS SIZE NORMAL, ECHOGENICITY. DIAGNOSTIC RESULTS: PLAINTIFF HAD DONE US TRANS-ABDOMINAL AND ENDO VAGINAL PELVIS ULTRASOUND. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: ABDOMINAL PAIN, PELVIC PAIN, BACK PAIN, MENORRHAGIA. 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 PTC INCIDENT WE RECEIVED A LOT NUMBER/RETURNED SAMPLE 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 ABDOMINAL PAIN ('SEVERE ABDOMINAL PAIN') IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822375) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY NO". MEDICAL CONDITIONS: PLAINTIFF HAD DONE US TRANS-ABDOMINAL AND ENDO VAGINAL PELVIS ULTRASOUND. CONCURRENT CONDITIONS INCLUDED ADENOMYOSIS, VAGINAL DISCHARGE, HAEMORRHAGE NOS, UTERINE TENDERNESS, ENDOMETRIOSIS, LOWER ABDOMINAL PAIN, ABNORMAL UTERINE BLEEDING, ALLERGY TO VACCINE, ANAPHYLACTIC SHOCK DUE TO EGGS, ANAPHYLACTIC REACTION, BONE MARROW TRANSPLANT, VOMITING AND PARATUBAL CYST. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN DIAGNOSTIC: CHRONIC PELVIC PAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (MENORRHAGIA)") AND UTERINE HAEMORRHAGE ("POOLED BLOOD IN MYOMETRIUM"), 1 YEAR 7 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), INFLAMMATION ("INFLAMMATION"), BACK PAIN ("SEVERE BACK PAIN") AND ADVERSE EVENT ("ABNORMAL SYMPTOMS"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY AND/OR HYSTERECTOMY TO REMOVE THE ESSURE ON (B)(6) 2012). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, INFLAMMATION, BACK PAIN, ADVERSE EVENT, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, NAUSEA AND UTERINE HAEMORRHAGE OUTCOME WAS UNKNOWN AND THE PELVIC PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADVERSE EVENT, BACK PAIN, HEAVY MENSTRUAL BLEEDING, INFLAMMATION, NAUSEA, PELVIC PAIN, UTERINE HAEMORRHAGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF WAS USING CONDOMS FROM (B)(6) 2011 TO (B)(6) 2011 TO PREVENT PREGNANCY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND PELVIS - ON (B)(6) 2012: RESULTS: UTERUS SIZE NORMAL, ECHOGENICITY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: ABDOMINAL PAIN, PELVIC PAIN, BACK PAIN, MENORRHAGIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: MR RECEIVED. REPORTER INFORMATION 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 ABDOMINAL PAIN ('SEVERE ABDOMINAL PAIN') IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822375) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY NO". MEDICAL CONDITIONS: PLAINTIFF HAD DONE US TRANS-ABDOMINAL AND ENDO VAGINAL PELVIS ULTRASOUND. CONCURRENT CONDITIONS INCLUDED ADENOMYOSIS, VAGINAL DISCHARGE, HAEMORRHAGE NOS, UTERINE TENDERNESS, ENDOMETRIOSIS, LOWER ABDOMINAL PAIN, ABNORMAL UTERINE BLEEDING, ALLERGY TO VACCINE, ANAPHYLACTIC SHOCK DUE TO EGGS, ANAPHYLACTIC REACTION, BONE MARROW TRANSPLANT, VOMITING AND PARATUBAL CYST. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN DIAGNOSTIC: CHRONIC PELVIC PAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (MENORRHAGIA)") AND UTERINE HAEMORRHAGE ("POOLED BLOOD IN MYOMETRIUM"), 1 YEAR 7 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), INFLAMMATION ("INFLAMMATION"), BACK PAIN ("SEVERE BACK PAIN") AND ADVERSE EVENT ("ABNORMAL SYMPTOMS"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY AND/OR HYSTERECTOMY TO REMOVE THE ESSURE ON (B)(6) 2012). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, INFLAMMATION, BACK PAIN, ADVERSE EVENT, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, NAUSEA AND UTERINE HAEMORRHAGE OUTCOME WAS UNKNOWN AND THE PELVIC PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADVERSE EVENT, BACK PAIN, HEAVY MENSTRUAL BLEEDING, INFLAMMATION, NAUSEA, PELVIC PAIN, UTERINE HAEMORRHAGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF WAS USING CONDOMS FROM (B)(6) 2011 TO PREVENT PREGNANCY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND PELVIS: ON (B)(6) 2012: RESULTS: UTERUS SIZE NORMAL, ECHOGENICITY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: ABDOMINAL PAIN, PELVIC PAIN, BACK PAIN, MENORRHAGIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JUL-2021: MR RECEIVED. REPORTER INFORMATION 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 ABDOMINAL PAIN ('SEVERE ABDOMINAL PAIN') IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822375) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY NO". MEDICAL CONDITIONS: PLAINTIFF HAD DONE US TRANS-ABDOMINAL AND ENDO VAGINAL PELVIS ULTRASOUND. CONCURRENT CONDITIONS INCLUDED ADENOMYOSIS, VAGINAL DISCHARGE, HAEMORRHAGE NOS, UTERINE TENDERNESS, ENDOMETRIOSIS, LOWER ABDOMINAL PAIN, ABNORMAL UTERINE BLEEDING, ALLERGY TO VACCINE, ANAPHYLACTIC SHOCK DUE TO EGGS, ANAPHYLACTIC REACTION, BONE MARROW TRANSPLANT, VOMITING AND PARATUBAL CYST. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN DIAGNOSTIC: CHRONIC PELVIC PAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (MENORRHAGIA)") AND UTERINE HAEMORRHAGE ("POOLED BLOOD IN MYOMETRIUM"), 1 YEAR 7 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), INFLAMMATION ("INFLAMMATION"), BACK PAIN ("SEVERE BACK PAIN") AND ADVERSE EVENT ("ABNORMAL SYMPTOMS"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY AND/OR HYSTERECTOMY TO REMOVE THE ESSURE ON (B)(6) 2012). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, INFLAMMATION, BACK PAIN, ADVERSE EVENT, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, NAUSEA AND UTERINE HAEMORRHAGE OUTCOME WAS UNKNOWN AND THE PELVIC PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADVERSE EVENT, BACK PAIN, HEAVY MENSTRUAL BLEEDING, INFLAMMATION, NAUSEA, PELVIC PAIN, UTERINE HAEMORRHAGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF WAS USING CONDOMS FROM (B)(6) 2011 TO PREVENT PREGNANCY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND PELVIS - ON (B)(6) 2012: RESULTS: UTERUS SIZE NORMAL, ECHOGENICITY. LOT NUMBER: 822375, MANUFACTURING DATE: 2011-01, EXPIRATION DATE: 2014-01 . 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 18-OCT-2021: 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 ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. 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 ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), INFLAMMATION ("INFLAMMATION"), BACK PAIN ("SEVERE BACK PAIN") AND ADVERSE EVENT ("ABNORMAL SYMPTOMS"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY AND/OR HYSTERECTOMY TO REMOVE THE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, INFLAMMATION, BACK PAIN AND ADVERSE EVENT OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADVERSE EVENT, BACK PAIN AND INFLAMMATION TO BE RELATED TO ESSURE. COMPANY CAUSALITY COMMENT: 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 |
|---|---|---|---|---|---|---|---|
| 790547 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822375 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Other| R |