ESSURE
Report
- Report Number
- 2951250-2017-02334
- Event Type
- Injury
- Date Received
- July 3, 2017
- Date of Event
- January 1, 2013
- Report Date
- March 11, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION (UTERUS).") IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841533, 841533) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "NOVASURE ABLATION WAS PERFORMED WITH ESSURE PLACEMENT". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ENDOMETRIOSIS AND UTERINE FIBROIDS (SMALL). CONCURRENT CONDITIONS INCLUDED MENOMETRORRHAGIA AND HYPERTENSION SINCE 2014. CONCOMITANT PRODUCTS INCLUDED ANTIHYPERTENSIVES. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN 2015, 3 YEARS 6 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND PELVIC PAIN. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"). THE PATIENT WAS TREATED WITH SURGERY (LAPROSCOPY: HYSTERECTOMY (PARTIAL),B/L SALPINGECTOMY, PRESERVATION OF OVARIES AND LYSIS OF ADHESIONS). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DYSMENORRHOEA, DYSPAREUNIA AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN AND THE VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, UTERINE PERFORATION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RETAIN THE ESSURE DEVICE OR ANY PORTION OF IT. SHE HAD COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE. YES-(B)(6) 2015-EXPLANATION OF SURGERY COMPLICATIONS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-FEB-2018: PFS RECEIVED: REPORTERS DETAILS ADDED. AKA NAMES ADDED. LOT NUMBER ADDED. EVENT ADDED AS ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PAIN, VAGINAL DISCHARGE, PERFORATION (UTERUS). HISTORICAL, CONCOMITANT CONDITION AND RELEVANT LAB DATA WERE ADDED. CONCOMITANT, HISTORICAL DRUGS AND TREATMENT DRUGS 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION (UTERUS)/ DISPLACED ESSURE DEVICE EXTRA UTERINE") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),") IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841533) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "NOVASURE ABLATION WAS PERFORMED WITH ESSURE PLACEMENT". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ENDOMETRIOSIS, UTERINE FIBROIDS (SMALL), RESTLESS LEG SYNDROME AND C-SECTION. CONCURRENT CONDITIONS INCLUDED MENOMETRORRHAGIA, HYPERTENSION SINCE 2014, ENDOMETRIAL CURETTAGE, BENIGN NEOPLASM, CERVIX INFLAMMATION, DYSFUNCTIONAL UTERINE BLEEDING, ABDOMINAL ADHESIONS, PELVIC ADHESIONS AND UTERINE ADHESIONS. CONCOMITANT PRODUCTS INCLUDED ANTIHYPERTENSIVES. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"). IN (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"). ON (B)(6) 2015, 3 YEARS 6 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND PELVIC PAIN. THE PATIENT WAS TREATED WITH SURGERY (LAPROSCOPY: HYSTERECTOMY (PARTIAL),B/L SALPINGECTOMY, PRESERVATION OF OVARIES AND LYSIS OF ADHESIONS) AND SURGERY (NOVA SURE ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DYSMENORRHOEA, DYSPAREUNIA AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN AND THE MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, UTERINE PERFORATION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RETAIN THE ESSURE DEVICE OR ANY PORTION OF IT. SHE HAD COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE. YES-(B)(6) 2015 EXPLANATION OF SURGERY COMPLICATIONS. ON (B)(6) 2012: 3 OILS IN THE RIGHT TUBE AND 1 COIL IN THE LEFT TUBE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: TOTAL BILATERAL OCCLUSION ON (B)(6) 2015: ULTRASOUND OF THE FEMALE PELVIS ¿ COMPLETE IMPRESSION: POSSIBLE MALPOSITION OF THE RIGHT ESSURE DEVICE POSSIBLY WITHIN THE FUNDUS OF THE UTERUS. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: ENDOMETRIAL CURETTAGE, BENIGN POLYP, CERVIX INFLAMMATION, PELVIC PAIN QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-JUL-2018: QUALITY-SAFETY EVALUATION OF PTC. 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 UTERINE PERFORATION ("PERFORATION (UTERUS)/ DISPLACED ESSURE DEVICE EXTRA UTERINE/ONE OF THE COILS WAS EMBEDDED IN UTERINE WALL"), EMBEDDED DEVICE ("ONE OF THE COILS WAS EMBEDDED IN UTERINE WALL") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),") IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841533) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "NOVASURE ABLATION WAS PERFORMED WITH ESSURE PLACEMENT". THE PATIENT'S MEDICAL HISTORY INCLUDED ENDOMETRIOSIS, UTERINE FIBROIDS (SMALL), RESTLESS LEG SYNDROME AND C-SECTION. CONCURRENT CONDITIONS INCLUDED MENOMETRORRHAGIA, HYPERTENSION SINCE (B)(6) , ENDOMETRIAL CURETTAGE, BENIGN NEOPLASM, CERVIX INFLAMMATION, DYSFUNCTIONAL UTERINE BLEEDING, ABDOMINAL ADHESIONS, PELVIC ADHESIONS AND UTERINE ADHESIONS. CONCOMITANT PRODUCTS INCLUDED ANTIHYPERTENSIVES. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) , THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"). IN (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"). ON (B)(6) 2015, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 YEARS 6 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN") AND SCAR ("LOT OF SCAR TISSUE AROUND THE BLADDER AND UTERUS THAT HE HAD TO DO WORK ON"). THE PATIENT WAS TREATED WITH SURGERY (LAPROSCOPY: HYSTERECTOMY (PARTIAL),B/L SALPINGECTOMY, PRESERVATION OF OVARIES AND LYSIS OF ADHESIONS AND NOVA SURE ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, EMBEDDED DEVICE, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE AND SCAR OUTCOME WAS UNKNOWN AND THE MENORRHAGIA, VAGINAL HAEMORRHAGE AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, MENORRHAGIA, SCAR, UTERINE PERFORATION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RETAIN THE ESSURE DEVICE OR ANY PORTION OF IT. SHE HAD COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE. YES-ON (B)(6) 2015-EXPLANATION OF SURGERY COMPLICATIONS. ON (B)(6) 2012: 3 OILS IN THE RIGHT TUBE AND 1 COIL IN THE LEFT TUBE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. ULTRASOUND PELVIS - ON (B)(6) 2015: RESULT: COMPLETE IMPRESSION: POSSIBLE MALPOSITION OF THE RIGHT ESSURE DEVICE POSSIBLY WITHIN THE FUNDUS OF THE UTERUS. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: ENDOMETRIAL CURETTAGE, BENIGN POLYP, CERVIX INFLAMMATION, PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-NOV-2018: PFS RECEIVED. FOLLOWING EVENTS WERE ADDED:ONE OF THE COILS WAS EMBEDDED IN UTERINE WALL, LOWER ABDOMINAL PAIN AND LOT OF SCAR TISSUE AROUND THE BLADDER AND UTERUS THAT HE HAD TO DO WORK ON. EVENT OUTCOME ADDED FOR LOWER ABDOMINAL PAIN. EVENT ONSET DATES WERE UPDATED. LAB DATA 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 UTERINE PERFORATION ("PERFORATION (UTERUS)/ DISPLACED ESSURE DEVICE EXTRA UTERINE/ONE OF THE COILS WAS EMBEDDED IN UTERINE WALL"), EMBEDDED DEVICE ("ONE OF THE COILS WAS EMBEDDED IN UTERINE WALL") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),") IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841533) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "NOVASURE ABLATION WAS PERFORMED WITH ESSURE PLACEMENT". THE PATIENT'S MEDICAL HISTORY INCLUDED ENDOMETRIOSIS, UTERINE FIBROIDS (SMALL), RESTLESS LEG SYNDROME AND C-SECTION. CONCURRENT CONDITIONS INCLUDED MENOMETRORRHAGIA, HYPERTENSION SINCE 2014, ENDOMETRIAL CURETTAGE, BENIGN NEOPLASM, CERVIX INFLAMMATION, DYSFUNCTIONAL UTERINE BLEEDING, ABDOMINAL ADHESIONS, PELVIC ADHESIONS AND UTERINE ADHESIONS. CONCOMITANT PRODUCTS INCLUDED ANTIHYPERTENSIVES. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"). IN (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"). ON (B)(6) 2015, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 YEARS 6 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN") AND SCAR ("LOT OF SCAR TISSUE AROUND THE BLADDER AND UTERUS THAT HE HAD TO DO WORK ON"). THE PATIENT WAS TREATED WITH SURGERY (LAPROSCOPY: HYSTERECTOMY (PARTIAL),B/L SALPINGECTOMY, PRESERVATION OF OVARIES AND LYSIS OF ADHESIONS AND NOVA SURE ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, EMBEDDED DEVICE, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE AND SCAR OUTCOME WAS UNKNOWN AND THE MENORRHAGIA, VAGINAL HAEMORRHAGE AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, MENORRHAGIA, SCAR, UTERINE PERFORATION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RETAIN THE ESSURE DEVICE OR ANY PORTION OF IT. SHE HAD COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE. YES- (B)(6) 2015-EXPLANATION OF SURGERY COMPLICATIONS. ON (B)(6) 2012: 3 OILS IN THE RIGHT TUBE AND 1 COIL IN THE LEFT TUBE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. ULTRASOUND PELVIS - ON (B)(6) 2015: RESULT: COMPLETE IMPRESSION: POSSIBLE MALPOSITION OF THE RIGHT ESSURE DEVICE POSSIBLY WITHIN THE FUNDUS OF THE UTERUS. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: ENDOMETRIAL CURETTAGE, BENIGN POLYP, CERVIX INFLAMMATION, PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED. FOLLOWING EVENTS WERE ADDED:ONE OF THE COILS WAS EMBEDDED IN UTERINE WALL, LOWER ABDOMINAL PAIN AND LOT OF SCAR TISSUE AROUND THE BLADDER AND UTERUS THAT HE HAD TO DO WORK ON. EVENT OUTCOME ADDED FOR LOWER ABDOMINAL PAIN. EVENT ONSET DATES WERE UPDATED. LAB DATA 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 PELVIC PAIN ("PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE. COMPANY CAUSALITY COMMENT: 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 |
|---|---|---|---|---|---|---|---|
| 464561 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841533 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Other| R | ANTIHYPERTENSIVES| ANTIHYPERTENSIVES| ANTIHYPERTENSIVES| ANTIHYPERTENSIVES| ANTIHYPERTENSIVES| LISINOPRIL |