ESSURE
Report
- Report Number
- 2951250-2017-07776
- Event Type
- Injury
- Date Received
- November 23, 2017
- Date of Event
- March 1, 2014
- Report Date
- July 23, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), DEVICE DISLOCATION ("THERE WERE NO VISIBLE COILS OF THE ESSURE NOTED FROM THE RIGHT OSTIA FROM A PREVIOUS ESSURE."), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, HEMORRHAGE)"), PELVIC ABSCESS ("POSTOPERATIVE PELVIC ABSCESS"), PELVIC HAEMATOMA ("MASS BETWEEN THE RECTUM AND BLADDER CONSISTENT WITH A HEMATOMA"), PYREXIA ("FEVER") AND PELVIC PAIN ("PAIN") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DEPLOYMENT ISSUE "IMPLANTED A LEFT COIL WITHIN A NONEXISTENT FALLOPIAN TUBE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HEADACHE, MIGRAINE AND HYSTERECTOMY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: LORTAB FROM 2012 TO (B)(6) 2013. CONCURRENT CONDITIONS INCLUDED BIPOLAR DISORDER, HYPERTENSION, THYROID DISORDER, ADENOMYOSIS AND NABOTHIAN CYST. CONCOMITANT PRODUCTS INCLUDED AXOTAL (FIORICET) SINCE 2012, DIAZEPAM (VALIUM) SINCE 2008, LITHIUM SINCE 2008, TOPIRAMATE (TOPAMAX) SINCE 2014 AND TRAZODONE SINCE 2013. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES"), HEADACHE ("MIGRAINES/HEADACHES") AND NAUSEA ("NAUSEA"). ON (B)(6) 2014, 26 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION HOSPITALIZATION), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN/DYSMENORRHEA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA HEMORRHAGE)"), MENORRHAGIA ("ABNORMAL MENSTRUAL BLEEDING / PROLONGED MENSES/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA HEMORRHAGE)"), ALOPECIA ("HAIR LOSS/HAIR LOSS"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN/LOSS") AND WEIGHT DECREASED ("WEIGHT GAIN/LOSS"). ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA"). ON (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE/VAGINAL DISCHARGE"). IN 2014, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC ABSCESS (SERIOUSNESS CRITERION HOSPITALIZATION), PELVIC HAEMATOMA (SERIOUSNESS CRITERION HOSPITALIZATION), PYREXIA (SERIOUSNESS CRITERION HOSPITALIZATION) AND FLANK PAIN ("PAIN ON LEFT SIDE"). THE PATIENT WAS HOSPITALIZED FOR 2 DAYS. THE PATIENT WAS TREATED WITH ANTIBIOTICS, ONDANSETRON (ZOFRAN), PROMETHAZINE, SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH RIGHT SALPINGECTOMY AND PARTIAL LEFT SALPINGECTOMY) AND SURGERY (ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH RIGHT SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC ABSCESS, PELVIC HAEMATOMA, PYREXIA, PELVIC PAIN, DYSMENORRHOEA, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSPAREUNIA, ALOPECIA, VAGINAL DISCHARGE, FATIGUE, NAUSEA, WEIGHT INCREASED, WEIGHT DECREASED AND FLANK PAIN HAD RESOLVED AND THE MIGRAINE AND HEADACHE HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FLANK PAIN, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC ABSCESS, PELVIC HAEMATOMA, PELVIC PAIN, PYREXIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON, (B)(6) 2014, PLAINTIFF UNDERWENT A SECOND IMPLANTATION PROCEDURE AND SUCCESSFULLY IMPLANTED AN ESSURE COIL WITHIN PLAINTIFF LEFT FALLOPIAN TUBE. BEGINNING SOMETIME IN LATE 2014, PLAINTIFF SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. PLAINTIFF HAS BEEN LEFT WITH ABDOMINAL DEFORMITY AND SEVERE LARGE SCARRMG. SINCE THE ESSURE REMOVAL SURGERY, PLAINTIFF HAS REPORTED THAT ALL HER SYMPTOMS HAVE RESOLVED AND THAT SHE FEELS MUCH BETTER. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 59.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: LEFT COIL WITHIN A NONEXISTENT FALLOPIAN TUBE; ON (B)(6) 2014: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED. A CT EXAM REVEALED A MASS BETWEEN THE RECTUM AND BLADDER CONSISTENT WITH A HEMATOMA. CT ABDOMEN AND PELVIS REPORT: 3.7 X 2.4 X 2.0 CM AIR AND FLUID COLLECTION IN THE HYSTERECTOMY BED, MAY REPRESENT HEMATOMA OR EARLY DEVELOPING ABSCESS FORMATION. HYSTEROSALPINGOGRAM: HYSTEROSALPINGOGRAM DEMONSTRATING SUCCESSFUL CLOSURE OF THE RIGHT FALLOPIAN TUBE. DEMONSTRATION OF A LEFT FALLOPIAN TUBE WHICH IS PATENT WITH SPILLAGE OF CONTRAST INTO THE LEFT SIDE OF THE PELVIS WHICH IS INCONSISTENT WITH THE PATIENT'S HISTORY OF LEFT FALLOPIAN TUBE REMOVAL AND LEFT OVARY REMOVAL. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-OCT-2018: PFS RECEIVED: EVENT PAIN ON LEFT SIDE ADDED AND OUTCOME UPDATED FOR ALL EVENT 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), DEVICE DISLOCATION ("THERE WERE NO VISIBLE COILS OF THE ESSURE NOTED FROM THE RIGHT OSTIA FROM A PREVIOUS ESSURE."), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, HEMORRHAGE)"), PELVIC ABSCESS ("POSTOPERATIVE PELVIC ABSCESS"), PELVIC HAEMATOMA ("MASS BETWEEN THE RECTUM AND BLADDER CONSISTENT WITH A HEMATOMA"), PYREXIA ("FEVER") AND PELVIC PAIN ("PAIN") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HEADACHE, MIGRAINE AND HYSTERECTOMY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: LORTAB FROM (B)(6) TO (B)(6) 2013. CONCURRENT CONDITIONS INCLUDED BIPOLAR DISORDER, HYPERTENSION, THYROID DISORDER, ADENOMYOSIS AND NABOTHIAN CYST. CONCOMITANT PRODUCTS INCLUDED AXOTAL (FIORICET) SINCE (B)(6) , DIAZEPAM (VALIUM) SINCE (B)(6) , LITHIUM SINCE (B)(6) , TOPIRAMATE (TOPAMAX) SINCE (B)(6) AND TRAZODONE SINCE (B)(6). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, 26 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN/DYSMENORRHEA"), PELVIC PAIN (SERIOUSNESS CRITERION HOSPITALIZATION), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA HEMORRHAGE)"), MENORRHAGIA ("ABNORMAL MENSTRUAL BLEEDING / PROLONGED MENSES/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA HEMORRHAGE)"), ALOPECIA ("HAIR LOSS/HAIR LOSS"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN/LOSS") AND WEIGHT DECREASED ("WEIGHT GAIN/LOSS"). ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA"). ON (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE/VAGINAL DISCHARGE"). IN (B)(6) , THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC ABSCESS (SERIOUSNESS CRITERION HOSPITALIZATION), PELVIC HAEMATOMA (SERIOUSNESS CRITERION HOSPITALIZATION), PYREXIA (SERIOUSNESS CRITERION HOSPITALIZATION), DEVICE DEPLOYMENT ISSUE ("IMPLANTED A LEFT COIL WITHIN A NONEXISTENT FALLOPIAN TUBE"), MIGRAINE ("MIGRAINES/HEADACHES"), HEADACHE ("MIGRAINES/HEADACHES") AND NAUSEA ("NAUSEA"). THE PATIENT WAS HOSPITALIZED FOR 2 DAYS. THE PATIENT WAS TREATED WITH ANTIBIOTICS, SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH RIGHT SALPINGECTOMY AND PARTIAL LEFT SALPINGECTOMY) AND SURGERY (ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH RIGHT SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, DEVICE DEPLOYMENT ISSUE, DYSMENORRHOEA, MENORRHAGIA, DYSPAREUNIA, ALOPECIA AND VAGINAL DISCHARGE HAD RESOLVED AND THE GENITAL HAEMORRHAGE, PELVIC ABSCESS, PELVIC HAEMATOMA, PYREXIA, PELVIC PAIN, VAGINAL HAEMORRHAGE, FATIGUE, MIGRAINE, HEADACHE, NAUSEA, WEIGHT INCREASED AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, DEVICE DEPLOYMENT ISSUE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC ABSCESS, PELVIC HAEMATOMA, PELVIC PAIN, PYREXIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON, (B)(6) 2014, PLAINTIFF UNDERWENT A SECOND IMPLANTATION PROCEDURE AND SUCCESSFULLY IMPLANTED AN ESSURE COIL WITHIN PLAINTIFF LEFT FALLOPIAN TUBE. BEGINNING SOMETIME IN LATE (B)(6) , PLAINTIFF SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. PLAINTIFF HAS BEEN LEFT WITH ABDOMINAL DEFORMITY AND SEVERE LARGE SCARRMG. SINCE THE ESSURE REMOVAL SURGERY, PLAINTIFF HAS REPORTED THAT ALL HER SYMPTOMS HAVE RESOLVED AND THAT SHE FEELS MUCH BETTER. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 59.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: LEFT COIL WITHIN A NONEXISTENT FALLOPIAN TUBE; ON (B)(6) 2014: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED. A CT EXAM REVEALED A MASS BETWEEN THE RECTUM AND BLADDER CONSISTENT WITH A HEMATOMA. CT ABDOMEN AND PELVIS REPORT: 3.7 X 2.4 X 2.0 CM AIR AND FLUID COLLECTION IN THE HYSTERECTOMY BED, MAY REPRESENT HEMATOMA OR EARLY DEVELOPING ABSCESS FORMATION. HYSTEROSALPINGOGRAM: HYSTEROSALPINGOGRAM DEMONSTRATING SUCCESSFUL CLOSURE OF THE RIGHT FALLOPIAN TUBE. DEMONSTRATION OF A LEFT FALLOPIAN TUBE WHICH IS PATENT WITH SPILLAGE OF CONTRAST INTO THE LEFT SIDE OF THE PELVIS WHICH IS INCONSISTENT WITH THE PATIENT'S HISTORY OF LEFT FALLOPIAN TUBE REMOVAL AND LEFT OVARY REMOVAL. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-MAR-2018: PLAINTIFF'S FACT SHEET AND MEDICAL RECORDS RECEIVED. ABNORMAL BLEEDING (VAGINAL, HEMORRHAGE, MENORRHAGIA), FATIGUE, MIGRAINES/HEADACHES, NAUSEA, PAIN, WEIGHT GAIN/LOSS, OTHER: POSTOPERATIVE PELVIC ABSCESS, HAEMATOMA,FEVER WERE ADDED, PATIENT'S MEDICAL HISTORY WAS UPDATED, PATIENT'S CONCOMITANT MEDICATIONS ADDED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), DEVICE DISLOCATION ("THERE WERE NO VISIBLE COILS OF THE ESSURE NOTED FROM THE RIGHT OSTIA FROM A PREVIOUS ESSURE."), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, HEMORRHAGE)"), PELVIC ABSCESS ("POSTOPERATIVE PELVIC ABSCESS"), PELVIC HAEMATOMA ("MASS BETWEEN THE RECTUM AND BLADDER CONSISTENT WITH A HEMATOMA"), PYREXIA ("FEVER") AND PELVIC PAIN ("PAIN") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HEADACHE, MIGRAINE AND HYSTERECTOMY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: LORTAB FROM 2012 TO MAY 2013. CONCURRENT CONDITIONS INCLUDED BIPOLAR DISORDER, HYPERTENSION, THYROID DISORDER, ADENOMYOSIS AND NABOTHIAN CYST. CONCOMITANT PRODUCTS INCLUDED AXOTAL (FIORICET) SINCE 2012, DIAZEPAM (VALIUM) SINCE 2008, LITHIUM SINCE 2008, TOPIRAMATE (TOPAMAX) SINCE 2014 AND TRAZODONE SINCE 2013. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN FEBRUARY 2014, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES"), HEADACHE ("MIGRAINES/HEADACHES") AND NAUSEA ("NAUSEA"). ON (B)(6) 2014, 26 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION HOSPITALIZATION), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN/DYSMENORRHEA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA HEMORRHAGE)"), MENORRHAGIA ("ABNORMAL MENSTRUAL BLEEDING / PROLONGED MENSES/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA HEMORRHAGE)"), ALOPECIA ("HAIR LOSS/HAIR LOSS"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN/LOSS") AND WEIGHT DECREASED ("WEIGHT GAIN/LOSS"). ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA"). ON (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE/VAGINAL DISCHARGE"). IN 2014, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC ABSCESS (SERIOUSNESS CRITERION HOSPITALIZATION), PELVIC HAEMATOMA (SERIOUSNESS CRITERION HOSPITALIZATION), PYREXIA (SERIOUSNESS CRITERION HOSPITALIZATION) AND DEVICE DEPLOYMENT ISSUE ("IMPLANTED A LEFT COIL WITHIN A NONEXISTENT FALLOPIAN TUBE"). THE PATIENT WAS HOSPITALIZED FOR 2 DAYS. THE PATIENT WAS TREATED WITH ANTIBIOTICS, ONDANSETRON (ZOFRAN), PROMETHAZINE, SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH RIGHT SALPINGECTOMY AND PARTIAL LEFT SALPINGECTOMY) AND SURGERY (ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH RIGHT SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, DEVICE DEPLOYMENT ISSUE, DYSMENORRHOEA, MENORRHAGIA, DYSPAREUNIA, ALOPECIA AND VAGINAL DISCHARGE HAD RESOLVED, THE GENITAL HAEMORRHAGE, PELVIC ABSCESS, PELVIC HAEMATOMA, PYREXIA, PELVIC PAIN, VAGINAL HAEMORRHAGE, FATIGUE, NAUSEA, WEIGHT INCREASED AND WEIGHT DECREASED OUTCOME WAS UNKNOWN AND THE MIGRAINE AND HEADACHE HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, DEVICE DEPLOYMENT ISSUE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC ABSCESS, PELVIC HAEMATOMA, PELVIC PAIN, PYREXIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON, (B)(6) 2014, PLAINTIFF UNDERWENT A SECOND IMPLANTATION PROCEDURE AND SUCCESSFULLY IMPLANTED AN ESSURE COIL WITHIN PLAINTIFF LEFT FALLOPIAN TUBE. BEGINNING SOMETIME IN LATE 2014, PLAINTIFF SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. PLAINTIFF HAS BEEN LEFT WITH ABDOMINAL DEFORMITY AND SEVERE LARGE SCARRMG. SINCE THE ESSURE REMOVAL SURGERY, PLAINTIFF HAS REPORTED THAT ALL HER SYMPTOMS HAVE RESOLVED AND THAT SHE FEELS MUCH BETTER. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 59.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: LEFT COIL WITHIN A NONEXISTENT FALLOPIAN TUBE; ON (B)(6) 2014: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED A CT EXAM REVEALED A MASS BETWEEN THE RECTUM AND BLADDER CONSISTENT WITH A HEMATOMA. CT ABDOMEN AND PELVIS REPORT: 3.7 X 2.4 X 2.0 CM AIR AND FLUID COLLECTION IN THE HYSTERECTOMY BED, MAY REPRESENT HEMATOMA OR EARLY DEVELOPING ABSCESS FORMATION. HYSTEROSALPINGOGRAM: HYSTEROSALPINGOGRAM DEMONSTRATING SUCCESSFUL CLOSURE OF THE RIGHT FALLOPIAN TUBE. DEMONSTRATION OF A LEFT FALLOPIAN TUBE WHICH IS PATENT WITH SPILLAGE OF CONTRAST INTO THE LEFT SIDE OF THE PELVIS WHICH IS INCONSISTENT WITH THE PATIENT'S HISTORY OF LEFT FALLOPIAN TUBE REMOVAL AND LEFT OVARY REMOVAL. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET-PATIENT WAS NOT RECOVERED FROM THE EVENTS MIGRAINE AND HEADACHE. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('SEVERE ABDOMINAL PAIN'), DEVICE DISLOCATION ('THERE WERE NO VISIBLE COILS OF THE ESSURE NOTED FROM THE RIGHT OSTIA FROM A PREVIOUS ESSURE.'), PELVIC ABSCESS ('POSTOPERATIVE PELVIC ABSCESS'), PELVIC HAEMATOMA ('MASS BETWEEN THE RECTUM AND BLADDER CONSISTENT WITH A HEMATOMA'), PYREXIA ('FEVER') AND PELVIC PAIN ('PAIN') IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PLACEMENT ISSUE "IMPLANTED A LEFT COIL WITHIN A NONEXISTENT FALLOPIAN TUBE". THE PATIENT'S MEDICAL HISTORY INCLUDED HEADACHE, MIGRAINE AND HYSTERECTOMY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: LORTAB FROM 2012 TO (B)(6) 2013. CONCURRENT CONDITIONS INCLUDED BIPOLAR DISORDER, HYPERTENSION, THYROID DISORDER, ADENOMYOSIS AND NABOTHIAN CYST. CONCOMITANT PRODUCTS INCLUDED BUTALBITAL;CAFFEINE;PARACETAMOL (FIORICET) SINCE 2012, DIAZEPAM (VALIUM) SINCE 2008, LITHIUM SINCE 2008, TOPIRAMATE (TOPAMAX) SINCE 2014 AND TRAZODONE SINCE 2013. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES"), HEADACHE ("MIGRAINES/HEADACHES") AND NAUSEA ("NAUSEA"). ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION HOSPITALIZATION), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN/DYSMENORRHEA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA HEMORRHAGE)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL MENSTRUAL BLEEDING / PROLONGED MENSES/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA HEMORRHAGE)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), ALOPECIA ("HAIR LOSS/HAIR LOSS") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/LOSS") AND WEIGHT DECREASED ("WEIGHT GAIN/LOSS"), 26 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA"). ON (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE/VAGINAL DISCHARGE"). IN 2014, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, HEMORRHAGE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC ABSCESS (SERIOUSNESS CRITERION HOSPITALIZATION), PELVIC HAEMATOMA (SERIOUSNESS CRITERION HOSPITALIZATION), PYREXIA (SERIOUSNESS CRITERION HOSPITALIZATION), FLANK PAIN ("PAIN ON LEFT SIDE") AND INFECTION ("INFECTION"). THE PATIENT WAS HOSPITALIZED FOR 2 DAYS. THE PATIENT WAS TREATED WITH ANTIBIOTICS, ONDANSETRON (ZOFRAN), PROMETHAZINE, I.V ANTIBIOTIC AND SURGERY (ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH RIGHT SALPINGECTOMY AND TOTAL LAPAROSCOPIC HYSTERECTOMY WITH RIGHT SALPINGECTOMY AND PARTIAL LEFT SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC ABSCESS, PELVIC HAEMATOMA, PYREXIA, PELVIC PAIN, DYSMENORRHOEA, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSPAREUNIA, ALOPECIA, VAGINAL DISCHARGE, FATIGUE, NAUSEA, WEIGHT INCREASED, WEIGHT DECREASED AND FLANK PAIN HAD RESOLVED, THE MIGRAINE AND HEADACHE HAD NOT RESOLVED AND THE INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FLANK PAIN, GENITAL HAEMORRHAGE, HEADACHE, INFECTION, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC ABSCESS, PELVIC HAEMATOMA, PELVIC PAIN, PYREXIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON, (B)(6) 2014, PLAINTIFF UNDERWENT A SECOND IMPLANTATION PROCEDURE AND SUCCESSFULLY IMPLANTED AN ESSURE COIL WITHIN PLAINTIFF LEFT FALLOPIAN TUBE. BEGINNING SOMETIME IN LATE 2014, PLAINTIFF SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. PLAINTIFF HAS BEEN LEFT WITH ABDOMINAL DEFORMITY AND SEVERE LARGE SCARRMG. SINCE THE ESSURE REMOVAL SURGERY, PLAINTIFF HAS REPORTED THAT ALL HER SYMPTOMS HAVE RESOLVED AND THAT SHE FEELS MUCH BETTER. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 59.2 KG/SQM. COMPUTERISED TOMOGRAM - ON AN UNKNOWN DATE: MASS BETWEEN THE RECTUM AND BLADDER CONSISTENT WITH A HEMATOMA. CT ABDOMEN AND PELVIS REPORT: 3.7 X 2.4 X 2.0 CM AIR AND FLUID COLLECTION IN THE HYSTERECTOMY BED, MAY REPRESENT HEMATOMA OR EARLY DEVELOPING ABSCESS FORMATION. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: RESULTS: LEFT COIL WITHIN A NONEXISTENT FALLOPIAN TUBE; ON (B)(6) 2014: RESULTS: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-JUN-2020: PFS RECEIVED NEW REPORTER INFORMATION. NEW EVENT INFECTION WAS ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION 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'), DEVICE DISLOCATION ('THERE WERE NO VISIBLE COILS OF THE ESSURE NOTED FROM THE RIGHT OSTIA FROM A PREVIOUS ESSURE.'), PELVIC ABSCESS ('POSTOPERATIVE PELVIC ABSCESS'), PELVIC HAEMATOMA ('MASS BETWEEN THE RECTUM AND BLADDER CONSISTENT WITH A HEMATOMA'), PYREXIA ('FEVER') AND PELVIC PAIN ('PAIN') IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PLACEMENT ISSUE "IMPLANTED A LEFT COIL WITHIN A NONEXISTENT FALLOPIAN TUBE". THE PATIENT'S MEDICAL HISTORY INCLUDED HEADACHE, MIGRAINE AND HYSTERECTOMY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: LORTAB FROM 2012 TO MAY 2013. CONCURRENT CONDITIONS INCLUDED BIPOLAR DISORDER, HYPERTENSION, THYROID DISORDER, ADENOMYOSIS AND NABOTHIAN CYST. CONCOMITANT PRODUCTS INCLUDED BUTALBITAL;CAFFEINE;PARACETAMOL (FIORICET) SINCE 2012, DIAZEPAM (VALIUM) SINCE 2008, LITHIUM SINCE 2008, TOPIRAMATE (TOPAMAX) SINCE 2014 AND TRAZODONE SINCE 2013. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES"), HEADACHE ("MIGRAINES/HEADACHES") AND NAUSEA ("NAUSEA"). ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION HOSPITALIZATION), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN/DYSMENORRHEA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA HEMORRHAGE)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL MENSTRUAL BLEEDING / PROLONGED MENSES/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA HEMORRHAGE)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), ALOPECIA ("HAIR LOSS/HAIR LOSS") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/LOSS") AND WEIGHT DECREASED ("WEIGHT GAIN/LOSS"), 26 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA"). ON (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE/VAGINAL DISCHARGE"). IN 2014, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, HEMORRHAGE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC ABSCESS (SERIOUSNESS CRITERION HOSPITALIZATION), PELVIC HAEMATOMA (SERIOUSNESS CRITERION HOSPITALIZATION), PYREXIA (SERIOUSNESS CRITERION HOSPITALIZATION), FLANK PAIN ("PAIN ON LEFT SIDE") AND INFECTION ("INFECTION"). THE PATIENT WAS HOSPITALIZED FOR 2 DAYS. THE PATIENT WAS TREATED WITH ANTIBIOTICS, ONDANSETRON (ZOFRAN), PROMETHAZINE, I.V ANTIBIOTIC AND SURGERY (ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH RIGHT SALPINGECTOMY AND TOTAL LAPAROSCOPIC HYSTERECTOMY WITH RIGHT SALPINGECTOMY AND PARTIAL LEFT SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC ABSCESS, PELVIC HAEMATOMA, PYREXIA, PELVIC PAIN, DYSMENORRHOEA, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSPAREUNIA, ALOPECIA, VAGINAL DISCHARGE, FATIGUE, NAUSEA, WEIGHT INCREASED, WEIGHT DECREASED AND FLANK PAIN HAD RESOLVED, THE MIGRAINE AND HEADACHE HAD NOT RESOLVED AND THE INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FLANK PAIN, GENITAL HAEMORRHAGE, HEADACHE, INFECTION, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC ABSCESS, PELVIC HAEMATOMA, PELVIC PAIN, PYREXIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON, (B)(6) 2014, PLAINTIFF UNDERWENT A SECOND IMPLANTATION PROCEDURE AND SUCCESSFULLY IMPLANTED AN ESSURE COIL WITHIN PLAINTIFF LEFT FALLOPIAN TUBE. BEGINNING SOMETIME IN LATE 2014, PLAINTIFF SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. PLAINTIFF HAS BEEN LEFT WITH ABDOMINAL DEFORMITY AND SEVERE LARGE SCARRMG. SINCE THE ESSURE REMOVAL SURGERY, PLAINTIFF HAS REPORTED THAT ALL HER SYMPTOMS HAVE RESOLVED AND THAT SHE FEELS MUCH BETTER. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 59.2 KG/SQM. COMPUTERISED TOMOGRAM - ON AN UNKNOWN DATE: MASS BETWEEN THE RECTUM AND BLADDER CONSISTENT WITH A HEMATOMA. CT ABDOMEN AND PELVIS REPORT: 3.7 X 2.4 X 2.0 CM AIR AND FLUID COLLECTION IN THE HYSTERECTOMY BED, MAY REPRESENT HEMATOMA OR EARLY DEVELOPING ABSCESS FORMATION.. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: RESULTS: LEFT COIL WITHIN A NONEXISTENT FALLOPIAN TUBE; ON (B)(6) 2014: RESULTS: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED. 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 (PRODUCT TECHNICAL COMPLAINT). BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENORRHAGIA ("ABNORMAL MENSTRUAL BLEEDING / PROLONGED MENSES"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ALOPECIA ("HAIR LOSS"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE") AND DEVICE DEPLOYMENT ISSUE ("IMPLANTED A LEFT COIL WITHIN A NONEXISTENT FALLOPIAN TUBE"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY TO REMOVE ESSURE). ESSURE WAS REMOVED IN (B)(6) 2015. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, DYSPAREUNIA, ALOPECIA, VAGINAL DISCHARGE AND DEVICE DEPLOYMENT ISSUE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, DEVICE DEPLOYMENT ISSUE, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON, (B)(6) 2014, PLAINTIFF UNDERWENT A SECOND IMPLANTATION PROCEDURE AND SUCCESSFULLY IMPLANTED AN ESSURE COIL WITHIN PLAINTIFF LEFT FALLOPIAN TUBE. BEGINNING SOMETIME IN LATE 2014, PLAINTIFF SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. PLAINTIFF HAS BEEN LEFT WITH ABDOMINAL DEFORMITY AND SEVERE LARGE SCARRING. SINCE THE ESSURE REMOVAL SURGERY, PLAINTIFF HAS REPORTED THAT ALL HER SYMPTOMS HAVE RESOLVED AND THAT SHE FEELS MUCH BETTER. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: LEFT COIL WITHIN A NONEXISTENT FALLOPIAN TUBE; ON (B)(6) 2014: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED 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 |
|---|---|---|---|---|---|---|---|
| 834599 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Hospitalization| O| R | FIORICET| FIORICET| FIORICET| FIORICET| FIORICET| LITHIUM| LITHIUM| LITHIUM| LITHIUM| LITHIUM| TOPAMAX| TOPAMAX| TOPAMAX| TOPAMAX| TOPAMAX| TRAZODONE| TRAZODONE| TRAZODONE| TRAZODONE| TRAZODONE| VALIUM| VALIUM| VALIUM| VALIUM| VALIUM |