ESSURE
Report
- Report Number
- 2951250-2017-02546
- Event Type
- Injury
- Date Received
- July 18, 2017
- Date of Event
- August 28, 2007
- Report Date
- August 29, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("SHE WAS ACTUALLY PREGNANT /ECTOPIC PREGNANCY"), FALLOPIAN TUBE PERFORATION ("PERFORATED THE RIGHT FALLOPIAN TUBE / PERFORATION (FALLOPIAN TUBE(S))"), UTERINE PERFORATION ("RIGHT ESSURE MICRO-INSERT HAD MIGRATED/ UTERINE PERFORATION ON THE RIGHT SIDE OBSERVED DURING OPERATION FOR RIGHT SIDE SALPINGECTOMY"), PROCEDURAL HAEMORRHAGE ("HEAVY BLEEDING") AND DEVICE DISLOCATION ("INABILITY TO LOCATE AND REMOVE THE LEFT ESSURE MICRO-INSERT/ UNABLE TO LOCATE THE LEFT ESSURE MICRO-INSERT AS IT HAD MIGRATED FROM THE FALLOPIAN TUBE / UNABLE TO LOCATE LEFT ESSURE INSERT, DUE TO ITS MIGRATION /MIGRATION OF ESSURE DEVICE") IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 823821) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "DOCTOR COULD NOT GET THE DEVICE INSTALLED IN THE RIGHT FALLOPIAN TUBE, AS IT WAS CURVED." ON 24-MAY-2007 AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 2 (B)(6) 1992, (B)(6) 1999), CHOLECYSTECTOMY, TONSILLECTOMY AND ADENOIDECTOMY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR TO PREVENT PREGNANCY: ORAL CONTRACEPTIVE NOS. CONCURRENT CONDITIONS INCLUDED AUGMENTATION MAMMOPLASTY, FIBROADENOMA OF BREAST, URINARY TRACT INFECTION, EUSTACHIAN TUBE DYSFUNCTION, PHARYNGITIS, ACCIDENT, OVARIAN CYST, BLEEDING INTERMENSTRUAL AND BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED TOPIRAMATE (TOPAMAX) FOR MIGRAINE AND HEADACHE AS WELL AS IBUPROFEN (ADVIL [IBUPROFEN]) SINCE 2007, IBUPROFEN (MIDOL CRAMP) SINCE 2007 AND TRAMADOL. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED COMPLICATION OF DEVICE INSERTION ("DOCTOR COULD NOT GET THE DEVICE INSTALLED IN THE RIGHT FALLOPIAN TUBE, AS IT WAS CURVED"). ON (B)(6) 2007, THE PATIENT EXPERIENCED MENORRHAGIA ("PROLONGED MENSES\ABNORMALLY HEAVY BLEEDING, DURING MENSTRUATION / ABNORMAL BLEEDING (MENORRHAGIA)"), DYSPAREUNIA ("PAINFUL INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2007, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN. ON (B)(6) 2007, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND SCAR ("SCAR TISSUE"). ON (B)(6) 2008, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS / HAIR LOSS"). ON (B)(6) 2008, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2009, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION : ANXIETY"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON (B)(6) 2014, THE PATIENT EXPERIENCED MENOPAUSAL SYMPTOMS ("HORMONAL CHANGES DESCRIBE: HORMONAL CHANGES THAT MIMIC MENOPAUSE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA HOSPITALIZATION PROLONGED AND MEDICALLY SIGNIFICANT) WITH UTERINE PAIN, PROCEDURAL HAEMORRHAGE (SERIOUSNESS CRITERIA HOSPITALIZATION PROLONGED AND MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("ABNORMALLY SEVERE PAIN, DURING MENSTRUATION"), BACK PAIN ("SEVERE BACK PAIN, WHEN NOT MENSTRUATING"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), INSOMNIA ("TROUBLE SLEEPING"), HOT FLUSH ("HOT FLASHES"), NIGHT SWEATS ("NIGHT SWEATS") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT WAS TREATED WITH NAPROXEN, SURGERY (RIGHT SIDE SALPINGECTOMY ON (B)(6) 2007) AND SURGERY (LEFT SALPINGO-OOPHORECTOMY ON (B)(6) 2014). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, ALOPECIA, FATIGUE, MENOPAUSAL SYMPTOMS, INSOMNIA, HOT FLUSH, NIGHT SWEATS, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY, MIGRAINE AND HEADACHE HAD RESOLVED, THE UTERINE PERFORATION, PROCEDURAL HAEMORRHAGE, SCAR, COMPLICATION OF DEVICE INSERTION AND ABDOMINAL PAIN WAS RESOLVING AND THE BACK PAIN, MENORRHAGIA AND WEIGHT FLUCTUATION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, BACK PAIN, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, FALLOPIAN TUBE PERFORATION, FATIGUE, HEADACHE, HOT FLUSH, INSOMNIA, MENOPAUSAL SYMPTOMS, MENORRHAGIA, MIGRAINE, NIGHT SWEATS, PROCEDURAL HAEMORRHAGE, SCAR, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: FROM MR: (B)(6) 2007: BOTH TUBAL OSTIA WERE NOTED AND THE LEFT FALLOPIAN TUBE WAS ESILY CANNULATED AND THE ESSURE DEVICE PLACED WITH APPROXIMATELY 6 COILS NOTED IN THE ENDOMETRIAL CAVITY WITH SUCCESSFUL PLACEMENT. THE RIGHT FALLOPIAN TUBE WAS DIFFICULT DUE TO THE ANGLE AND 1 COIL WAS SUBSEQUENTLY UTILIZED UNSUCCESSFULLY. A SECOND COIL WAS USED ON THE RIGHT SIDE WHICH WAS SUCCESSFUL IN PLACEMENT AND APPROXIMATELY 8 O 9 COILS WERE VISUALIZED ON THE RIGHT SIDE. THE PATIENT TOLERATED THE PROCEDURE WELL. FROM MR: (B)(6) 2007: ESSURE TIP WAS NOTED AT THE RIGHT CORNUA OF UTERUS. REMOVED THE ESSURE COIL BY GRABBING AND PULLING THROUGH SEROSAL SURFACE WITHOUT ANY DIFFICULTY. THE COIL WAS REMOVED AND THE RIGHT FALLOPIAN TUBE HAD ESSENTIALLY BEEN COAGULATED IN THE PROCESS OF PERFORMING THE SALPINGECTOMY. THE PATIENT TOLERATED THE PROCEDURE WELL. SHE DID HAVE EVIDENCE ON THE RIGHT SIDE OF A COIL THAT HAD A MICRO PERFORATION. FROM MR: (B)(6) 2014: THE LEFT ADNEXA WAS PLACED IN AN ENDO BAG AND REMOVED THROUGH THE UMBILICAL INCISION. SUCTION IRRIGATION WAS PERFORMED. THERE WAS SOME BLEEDING NEAR THE LEFT CORNUA OF THE UTERUS. AFTER REMOVING THE LEFT ADNEXA, THE ESSURE COIL WAS VISIBLE PROTRUDING FROM THE STUMP OF THE LEFT FALLOPIAN TUBE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.4 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2007: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES IN OR ABOUT THE SPRING OF 2008, ULTRASOUND PELVIS SHOWED RIGHT ESSURE MICRO-INSERT HAD MIGRATED AND PERFORATED THE RIGHT FALLOPIAN TUBE. (B)(6) 2008 : URINE PREGNANCY TEST WAS NEGATIVE ON THE DAY SURGERY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: ECTOPIC PREGNANCY, SCAR TISSUE, DYSMENORRHEA AND MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-JUN-2018: PFS RECEIVED. REPORTER INFORMATION ADDED. CONCOMITANT DRUG, TREATMENT DRUG WERE ADDED. ADDED EVENT ABDOMINAL PAIN, UTERUS PAIN. UPDATED ONSET DATE, OUTCOME. 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.
ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("SHE WAS ACTUALLY PREGNANT /ECTOPIC PREGNANCY"), FALLOPIAN TUBE PERFORATION ("PERFORATED THE RIGHT FALLOPIAN TUBE / PERFORATION (FALLOPIAN TUBE(S))"), UTERINE PERFORATION ("RIGHT ESSURE MICRO-INSERT HAD MIGRATED/ UTERINE PERFORATION ON THE RIGHT SIDE OBSERVED DURING OPERATION FOR RIGHT SIDE SALPINGECTOMY"), PROCEDURAL HAEMORRHAGE ("HEAVY BLEEDING") AND DEVICE DISLOCATION ("INABILITY TO LOCATE AND REMOVE THE LEFT ESSURE MICRO-INSERT/ UNABLE TO LOCATE THE LEFT ESSURE MICRO-INSERT AS IT HAD MIGRATED FROM THE FALLOPIAN TUBE / UNABLE TO LOCATE LEFT ESSURE INSERT, DUE TO ITS MIGRATION /MIGRATION OF ESSURE DEVICE") IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 823821-INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "DOCTOR COULD NOT GET THE DEVICE INSTALLED IN THE RIGHT FALLOPIAN TUBE, AS IT WAS CURVED." ON (B)(6) 2007 AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 2 ((B)(6) 1992, (B)(6) 1999), CHOLECYSTECTOMY, TONSILLECTOMY AND ADENOIDECTOMY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR TO PREVENT PREGNANCY: ORAL CONTRACEPTIVE NOS. CONCURRENT CONDITIONS INCLUDED AUGMENTATION MAMMOPLASTY, FIBROADENOMA OF BREAST, URINARY TRACT INFECTION, EUSTACHIAN TUBE DYSFUNCTION, PHARYNGITIS, ACCIDENT, OVARIAN CYST, BLEEDING INTERMENSTRUAL AND BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED TOPIRAMATE (TOPAMAX) FOR MIGRAINE AND HEADACHE AS WELL AS IBUPROFEN (ADVIL [IBUPROFEN]) SINCE 2007, IBUPROFEN (MIDOL CRAMP) SINCE 2007 AND TRAMADOL. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED COMPLICATION OF DEVICE INSERTION ("DOCTOR COULD NOT GET THE DEVICE INSTALLED IN THE RIGHT FALLOPIAN TUBE, AS IT WAS CURVED"). ON (B)(6) 2007, THE PATIENT EXPERIENCED MENORRHAGIA ("PROLONGED MENSES\ABNORMALLY HEAVY BLEEDING, DURING MENSTRUATION / ABNORMAL BLEEDING (MENORRHAGIA)"), DYSPAREUNIA ("PAINFUL INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2007, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN. ON (B)(6) 2007, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND SCAR ("SCAR TISSUE"). ON (B)(6) 2008, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS / HAIR LOSS"). ON (B)(6) 2008, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2009, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION : ANXIETY"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON (B)(6) 2014, THE PATIENT EXPERIENCED MENOPAUSAL SYMPTOMS ("HORMONAL CHANGES DESCRIBE: HORMONAL CHANGES THAT MIMIC MENOPAUSE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA HOSPITALIZATION PROLONGED AND MEDICALLY SIGNIFICANT) WITH UTERINE PAIN, PROCEDURAL HAEMORRHAGE (SERIOUSNESS CRITERIA HOSPITALIZATION PROLONGED AND MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("ABNORMALLY SEVERE PAIN, DURING MENSTRUATION"), BACK PAIN ("SEVERE BACK PAIN, WHEN NOT MENSTRUATING"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), INSOMNIA ("TROUBLE SLEEPING"), HOT FLUSH ("HOT FLASHES"), NIGHT SWEATS ("NIGHT SWEATS") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE (ESS205) IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH NAPROXEN, SURGERY (RIGHT SIDE SALPINGECTOMY ON (B)(6) 2007), SURGERY (RIGHT SALPINGECTOMY) AND SURGERY (LEFT SALPINGO-OOPHORECTOMY ON (B)(6) 2014). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, ALOPECIA, FATIGUE, MENOPAUSAL SYMPTOMS, INSOMNIA, HOT FLUSH, NIGHT SWEATS, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY, MIGRAINE AND HEADACHE HAD RESOLVED, THE UTERINE PERFORATION, PROCEDURAL HAEMORRHAGE, SCAR, COMPLICATION OF DEVICE INSERTION AND ABDOMINAL PAIN WAS RESOLVING AND THE BACK PAIN, MENORRHAGIA AND WEIGHT FLUCTUATION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, BACK PAIN, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, FALLOPIAN TUBE PERFORATION, FATIGUE, HEADACHE, HOT FLUSH, INSOMNIA, MENOPAUSAL SYMPTOMS, MENORRHAGIA, MIGRAINE, NIGHT SWEATS, PROCEDURAL HAEMORRHAGE, SCAR, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: FROM MR: (B)(6) 2007: BOTH TUBAL OSTIA WERE NOTED AND THE LEFT FALLOPIAN TUBE WAS EASILY CANNULATED AND THE ESSURE DEVICE PLACED WITH APPROXIMATELY 6 COILS NOTED IN THE ENDOMETRIAL CAVITY WITH SUCCESSFUL PLACEMENT. THE RIGHT FALLOPIAN TUBE WAS DIFFICULT DUE TO THE ANGLE AND 1 COIL WAS SUBSEQUENTLY UTILIZED UNSUCCESSFULLY. A SECOND COIL WAS USED ON THE RIGHT SIDE WHICH WAS SUCCESSFUL IN PLACEMENT AND APPROXIMATELY 8 O 9 COILS WERE VISUALIZED ON THE RIGHT SIDE. THE PATIENT TOLERATED THE PROCEDURE WELL. FROM MR: (B)(6) 2007: ESSURE TIP WAS NOTED AT THE RIGHT CORNUA OF UTERUS. REMOVED THE ESSURE COIL BY GRABBING AND PULLING THROUGH SEROSAL SURFACE WITHOUT ANY DIFFICULTY. THE COIL WAS REMOVED AND THE RIGHT FALLOPIAN TUBE HAD ESSENTIALLY BEEN COAGULATED IN THE PROCESS OF PERFORMING THE SALPINGECTOMY. THE PATIENT TOLERATED THE PROCEDURE WELL. SHE DID HAVE EVIDENCE ON THE RIGHT SIDE OF A COIL THAT HAD A MICRO PERFORATION. FROM MR: (B)(6) 2014: THE LEFT ADNEXA WAS PLACED IN AN ENDO BAG AND REMOVED THROUGH THE UMBILICAL INCISION. SUCTION IRRIGATION WAS PERFORMED. THERE WAS SOME BLEEDING NEAR THE LEFT CORNUA OF THE UTERUS. AFTER REMOVING THE LEFT ADNEXA, THE ESSURE COIL WAS VISIBLE PROTRUDING FROM THE STUMP OF THE LEFT FALLOPIAN TUBE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.4 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2007: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES IN OR ABOUT THE SPRING OF 2008, ULTRASOUND PELVIS SHOWED RIGHT ESSURE MICRO-INSERT HAD MIGRATED AND PERFORATED THE RIGHT FALLOPIAN TUBE. (B)(6) 2008 : URINE PREGNANCY TEST WAS NEGATIVE ON THE DAY SURGERY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: ECTOPIC PREGNANCY, SCAR TISSUE, DYSMENORRHEA AND MENORRHAGIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-AUG-2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("SHE WAS ACTUALLY PREGNANT /ECTOPIC PREGNANCY"), FALLOPIAN TUBE PERFORATION ("PERFORATED THE RIGHT FALLOPIAN TUBE / PERFORATION (FALLOPIAN TUBE(S))"), UTERINE PERFORATION ("RIGHT ESSURE MICRO-INSERT HAD MIGRATED/ UTERINE PERFORATION ON THE RIGHT SIDE OBSERVED DURING OPERATION FOR RIGHT SIDE SALPINGECTOMY"), PROCEDURAL HAEMORRHAGE ("HEAVY BLEEDING") AND DEVICE DISLOCATION ("INABILITY TO LOCATE AND REMOVE THE LEFT ESSURE MICRO-INSERT/ UNABLE TO LOCATE THE LEFT ESSURE MICRO-INSERT AS IT HAD MIGRATED FROM THE FALLOPIAN TUBE / UNABLE TO LOCATE LEFT ESSURE INSERT, DUE TO ITS MIGRATION") IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 823821) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "DOCTOR COULD NOT GET THE DEVICE INSTALLED IN THE RIGHT FALLOPIAN TUBE, AS IT WAS CURVED." ON (B)(6) 2007 AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 4, CHOLECYSTECTOMY, TONSILLECTOMY AND ADENOIDECTOMY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR TO PREVENT PREGNANCY: ORAL CONTRACEPTIVE NOS. CONCURRENT CONDITIONS INCLUDED AUGMENTATION MAMMOPLASTY, FIBROADENOMA OF BREAST, URINARY TRACT INFECTION, EUSTACHIAN TUBE DYSFUNCTION, PHARYNGITIS, ACCIDENT, OVARIAN CYST AND BLEEDING INTERMENSTRUAL. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED COMPLICATION OF DEVICE INSERTION ("DOCTOR COULD NOT GET THE DEVICE INSTALLED IN THE RIGHT FALLOPIAN TUBE, AS IT WAS CURVED"). ON (B)(6) 2007, THE PATIENT EXPERIENCED MENORRHAGIA ("PROLONGED MENSES\ABNORMALLY HEAVY BLEEDING, DURING MENSTRUATION / ABNORMAL BLEEDING (MENORRHAGIA)"), DYSPAREUNIA ("PAINFUL INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2007, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN. ON (B)(6) 2007, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND SCAR ("SCAR TISSUE"). ON (B)(6) 2008, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS / HAIR LOSS"). ON (B)(6) 2008, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE "). ON (B)(6) 2009, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION : ANXIETY"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON (B)(6) 2014, THE PATIENT EXPERIENCED MENOPAUSAL SYMPTOMS ("HORMONAL CHANGES DESCRIBE: HORMONAL CHANGES THAT MIMIC MENOPAUSE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA HOSPITALIZATION PROLONGED AND MEDICALLY SIGNIFICANT), PROCEDURAL HAEMORRHAGE (SERIOUSNESS CRITERIA HOSPITALIZATION PROLONGED AND MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("ABNORMALLY SEVERE PAIN, DURING MENSTRUATION"), BACK PAIN ("SEVERE BACK PAIN, WHEN NOT MENSTRUATING"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), INSOMNIA ("TROUBLE SLEEPING"), HOT FLUSH ("HOT FLASHES") AND NIGHT SWEATS ("NIGHT SWEATS"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE (ESS205) IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (RIGHT SIDE SALPINGECTOMY ON (B)(6) 2007) AND LEFT SALPINGO-OOPHORECTOMY ON (B)(6) 2014. ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, ALOPECIA, FATIGUE, MENOPAUSAL SYMPTOMS, INSOMNIA, HOT FLUSH, NIGHT SWEATS, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY, MIGRAINE AND HEADACHE HAD RESOLVED, THE UTERINE PERFORATION, PROCEDURAL HAEMORRHAGE, SCAR AND COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN AND THE BACK PAIN, MENORRHAGIA AND WEIGHT FLUCTUATION HAD NOT RESOLVED. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, BACK PAIN, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, FALLOPIAN TUBE PERFORATION, FATIGUE, HEADACHE, HOT FLUSH, INSOMNIA, MENOPAUSAL SYMPTOMS, MENORRHAGIA, MIGRAINE, NIGHT SWEATS, PROCEDURAL HAEMORRHAGE, SCAR, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: FROM MR: (B)(6) 2007: BOTH TUBAL OSTIA WERE NOTED AND THE LEFT FALLOPIAN TUBE WAS EASILY CANNULATED AND THE ESSURE DEVICE PLACED WITH APPROXIMATELY 6 COILS NOTED IN THE ENDOMETRIAL CAVITY WITH SUCCESSFUL PLACEMENT. THE RIGHT FALLOPIAN TUBE WAS DIFFICULT DUE TO THE ANGLE AND 1 COIL WAS SUBSEQUENTLY UTILIZED UNSUCCESSFULLY. A SECOND COIL WAS USED ON THE RIGHT SIDE WHICH WAS SUCCESSFUL IN PLACEMENT AND APPROXIMATELY 8 O 9 COILS WERE VISUALIZED ON THE RIGHT SIDE. THE PATIENT TOLERATED THE PROCEDURE WELL. FROM MR: (B)(6) 2007: ESSURE TIP WAS NOTED AT THE RIGHT CORNUA OF UTERUS. REMOVED THE ESSURE COIL BY GRABBING AND PULLING THROUGH SEROSAL SURFACE WITHOUT ANY DIFFICULTY. THE COIL WAS REMOVED AND THE RIGHT FALLOPIAN TUBE HAD ESSENTIALLY BEEN COAGULATED IN THE PROCESS OF PERFORMING THE SALPINGECTOMY. THE PATIENT TOLERATED THE PROCEDURE WELL. SHE DID HAVE EVIDENCE ON THE RIGHT SIDE OF A COIL THAT HAD A MICRO PERFORATION. FROM MR: (B)(6) 2014: THE LEFT ADNEXA WAS PLACED IN AN ENDO BAG AND REMOVED THROUGH THE UMBILICAL INCISION. SUCTION IRRIGATION WAS PERFORMED. THERE WAS SOME BLEEDING NEAR THE LEFT CORNUA OF THE UTERUS. AFTER REMOVING THE LEFT ADNEXA, THE ESSURE COIL WAS VISIBLE PROTRUDING FROM THE STUMP OF THE LEFT FALLOPIAN TUBE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 69.85 KGS. HYSTEROSALPINGOGRAM - ON (B)(6) 2007: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES IN OR ABOUT THE SPRING OF 2008, ULTRASOUND PELVIS SHOWED RIGHT ESSURE MICRO-INSERT HAD MIGRATED AND PERFORATED THE RIGHT FALLOPIAN TUBE. (B)(6) 2008 : URINE PREGNANCY TEST WAS NEGATIVE ON THE DAY SURGERY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: ECTOPIC PREGNANCY, SCAR TISSUE, DYSMENORRHEA AND MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: EVENTS- "HORMONAL CHANGES DESCRIBE: HORMONAL CHANGES THAT MIMIC MENOPAUSE, TROUBLE SLEEPING, HOT FLASHES, NIGHT SWEATS, ABNORMAL BLEEDING (VAGINAL), PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION : ANXIETY, MIGRAINES, HEADACHES, PAIN, DOCTOR COULD NOT GET THE DEVICE INSTALLED IN THE RIGHT FALLOPIAN TUBE, AS IT WAS CURVED ,SCAR TISSUE, HEAVY BLEEDING,", LOT NUMBER, CONCOMITANT AND HISTORICAL CONDITION, REPORTER ADDED FROM PFS. ON (B)(6) 2018: CASE BECAME MEDICALLY CONFIRM. HISTORICAL AND CONCOMITANT CONDITION ADDED FROM MEDICAL RECORD. BOTH FOLLOW UP PROCESS TOGETHER. 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 RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATED THE RIGHT FALLOPIAN TUBE"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("SHE WAS ACTUALLY PREGNANT"), THE FIRST EPISODE OF DEVICE DISLOCATION ("UNABLE TO LOCATE THE LEFT ESSURE MICRO-INSERT AS IT HAD MIGRATED FROM THE FALLOPIAN TUBE") AND THE SECOND EPISODE OF DEVICE DISLOCATION ("RIGHT ESSURE MICRO-INSERT HAD MIGRATED") IN A FEMALE PATIENT WHO HAD ESSURE (B)(4) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "INABILITY TO LOCATE AND REMOVE THE LEFT ESSURE MICRO-INSERT" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". IN (B)(6) 2007, THE PATIENT HAD ESSURE (B)(4) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE FIRST EPISODE OF DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE SECOND EPISODE OF DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("ABNORMALLY SEVERE PAIN, DURING MENSTRUATION"), BACK PAIN ("SEVERE BACK PAIN, WHEN NOT MENSTRUATING"), MENORRHAGIA ("PROLONGED MENSES\ABNORMALLY HEAVY BLEEDING, DURING MENSTRUATION"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), ALOPECIA ("HAIR LOSS"), FATIGUE AND COMPLICATION OF DEVICE REMOVAL ("INABILITY TO LOCATE AND REMOVE THE LEFT ESSURE MICRO-INSERT"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE (B)(4) IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (RIGHT SALPINGECTOMY), SURGERY (TERMINATE THE PREGNANCY(ELECTIV ABORTION)) AND SURGERY (LEFT SALPINGO-OOPHORECTOMY IN (B)(6) 2014). AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, THE LAST EPISODE OF DEVICE DISLOCATION, DYSMENORRHOEA, BACK PAIN, MENORRHAGIA, DYSPAREUNIA, WEIGHT FLUCTUATION, ALOPECIA AND FATIGUE HAD NOT RESOLVED AND THE COMPLICATION OF DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED ALOPECIA, BACK PAIN, COMPLICATION OF DEVICE REMOVAL, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, MENORRHAGIA, PREGNANCY WITH CONTRACEPTIVE DEVICE, WEIGHT FLUCTUATION, THE FIRST EPISODE OF DEVICE DISLOCATION AND THE SECOND EPISODE OF DEVICE DISLOCATION TO BE RELATED TO ESSURE (B)(4). THE REPORTER COMMENTED: DESPITE HER SURGERIES PLAINTIFF STILL SUFFERS TO THE DAY FROM THE SYMPTOMS OUTLINED ABOVE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2007: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES IN OR ABOUT THE SPRING OF 2008, ULTRASOUND PELVIS SHOWED RIGHT ESSURE MICRO-INSERT HAD MIGRATED AND PERFORATED THE RIGHT FALLOPIAN TUBE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-JUL-2017: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATED THE RIGHT FALLOPIAN TUBE"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("SHE WAS ACTUALLY PREGNANT"), THE FIRST EPISODE OF DEVICE DISLOCATION ("UNABLE TO LOCATE THE LEFT ESSURE MICRO-INSERT AS IT HAD MIGRATED FROM THE FALLOPIAN TUBE") AND THE SECOND EPISODE OF DEVICE DISLOCATION ("RIGHT ESSURE MICRO-INSERT HAD MIGRATED") IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "INABILITY TO LOCATE AND REMOVE THE LEFT ESSURE MICRO-INSERT" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". IN (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND THE PATIENT WAS TREATED WITH SURGERY (RIGHT SALPINGECTOMY), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND SURGERY (TERMINATE THE PREGNANCY(ELECTIVE ABORTION)), THE FIRST EPISODE OF DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND SURGERY (LEFT SALPINGO-OOPHORECTOMY IN (B)(6) 2014), THE SECOND EPISODE OF DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("ABNORMALLY SEVERE PAIN, DURING MENSTRUATION"), BACK PAIN ("SEVERE BACK PAIN, WHEN NOT MENSTRUATING"), MENORRHAGIA ("PROLONGED MENSES\ABNORMALLY HEAVY BLEEDING, DURING MENSTRUATION"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), ALOPECIA ("HAIR LOSS"), FATIGUE ("FATIGUE") AND COMPLICATION OF DEVICE REMOVAL ("INABILITY TO LOCATE AND REMOVE THE LEFT ESSURE MICRO-INSERT"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WAS NOT PROVIDED. THE PATIENT HAD ESSURE (ESS205) DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (RIGHT SALPINGECTOMY), SURGERY (TERMINATE THE PREGNANCY(ELECTIVE ABORTION)) AND SURGERY (LEFT SALPINGO-OOPHORECTOMY IN (B)(6) 2014). AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, THE LAST EPISODE OF DEVICE DISLOCATION, DYSMENORRHOEA, BACK PAIN, MENORRHAGIA, DYSPAREUNIA, WEIGHT FLUCTUATION, ALOPECIA AND FATIGUE HAD NOT RESOLVED AND THE COMPLICATION OF DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED ALOPECIA, BACK PAIN, COMPLICATION OF DEVICE REMOVAL, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, MENORRHAGIA, PREGNANCY WITH CONTRACEPTIVE DEVICE, WEIGHT FLUCTUATION, THE FIRST EPISODE OF DEVICE DISLOCATION AND THE SECOND EPISODE OF DEVICE DISLOCATION TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: DESPITE HER SURGERIES PLAINTIFF STILL SUFFERS TO THE DAY FROM THE SYMPTOMS OUTLINED ABOVE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2007: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES. IN OR ABOUT THE SPRING OF 2008, ULTRASOUND PELVIS SHOWED RIGHT ESSURE MICRO-INSERT HAD MIGRATED AND PERFORATED THE RIGHT FALLOPIAN TUBE. 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 |
|---|---|---|---|---|---|---|---|
| 502050 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 | 823821-INVALID |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Hospitalization| O| R | ADVIL [IBUPROFEN].| MIDOL CRAMP.| TOPAMAX.| TRAMADOL. |