ESSURE
Report
- Report Number
- 2951250-2019-05083
- Event Type
- Injury
- Date Received
- August 26, 2019
- Date of Event
- June 1, 2014
- Report Date
- June 11, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PLAINTIFF HAS SUFFERED PHYSICAL PAIN') AND GENITAL HAEMORRHAGE ('GENERAL. ABNORMAL. BLEEDING') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 043322-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DRY SKIN, COLD SORES, BLOOD PRESSURE HIGH, MENSES IRREGULAR, VAGINAL DISCHARGE, BACK PAIN, JOINT PAIN, MUSCLE SPASMS, WEAKNESS, ANEMIA, CROHN'S DISEASE, EPIDERMOLYSIS BULLOSA, DIABETES, HIGH CHOLESTEROL, HYPERLIPIDEMIA, ASTHMA AND PREMATURE BABY. CURRENT WEIGHT 163LBS. CONCURRENT CONDITIONS INCLUDED HYPERTENSION, GERD, TOBACCO USE DISORDER, UTERINE BLEEDING, ABDOMINAL CRAMPS, LEIOMYOMA NOS, METRORRHAGIA, FIBROIDS AND POSTOPERATIVE INFECTION. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) UNTIL (B)(6) 2014 FOR CONTRACEPTION AS WELL AS ATROPINE, BACLOFEN FROM (B)(6) 2014 TO (B)(6) 2014, DOXEPIN FROM (B)(6) 2014 TO (B)(6) 2014, FENTANYL FROM (B)(6) 2014 TO (B)(6) 2014, HYDROMORPHONE HYDROCHLORIDE (DILAUDID) FROM (B)(6) 2014 TO (B)(6) 2016, KETOROLAC TROMETHAMINE (TORADOL), METOPROLOL SUCCINATE (TOPROL) FROM (B)(6) 2014 TO (B)(6) 2016 AND OMEPRAZOLE MAGNESIUM (PRILOSEC) FROM (B)(6) 2014 TO (B)(6) 2014. IN (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, DEPRESSION AND MENTAL ANGUISH/ PSYCH INJURY") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, DEPRESSION AND MENTAL ANGUIS/ PSYCH INJURY,"). IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/ LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND METRORRHAGIA ("METORHAGIA (BLEEDING B/W PERIODS)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN AND METRORRHAGIA HAD RESOLVED AND THE DEPRESSION, ANXIETY, MIGRAINE, NAUSEA, VAGINAL DISCHARGE, FATIGUE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, METRORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE, IT WAS GIVEN (B)(6)2014 INITIALLY, BUT IN CURRENT PFS (B)(6) 2014 WAS GIVEN. CURRENT WEIGHT 163LBS. 3 TRAILING COILS WERE VISIBLE (LEFT). 5 TRAILING COILS WERE VISIBLE (RIGHT). PATIENT RECEIVED TREATMENT FOR PELVIC/ ABDOMINAL, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING),METORHAGIA (BLEEDING B/W PERIODS),GENERAL. ABNORMAL. BLEEDING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 73.469 KGS. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.; ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION. THE FALLOPIAN TUBES WERE BLOCKED. PREGNANCY TEST - ON (B)(6) 2014: NEGATIVE. ULTRASOUND SCAN - ON (B)(6) 2014: INTRAMURAL FIBROID VS ENDOMETRIAL POLYP MEASURING 3.1 X 304 CM, RT OVARY APPEARS WNL, LT OVARY SEEN WITH MULTIPLE PERIPHERAL FOLLICLES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING: FATIGUE, MENORRHAGIA, ANXIETY, DYSMENORRHEA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PLAINTIFF FACT SHEET RECEIVED. EVENTS ADDED FROM PFS- ABDOMINAL PAIN, METORHAGIA (BLEEDING B/W PERIODS),GENERAL. ABNORMAL. BLEEDING, PSYCH INJURY. OUTCOME OF EVENT PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA. INCIDENT. NO VALID LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 PELVIC PAIN ('PLAINTIFF HAS SUFFERED PHYSICAL PAIN'), SALPINGITIS ('ACUTE AND CHRONIC SALPINGITIS') AND GENITAL HAEMORRHAGE ('GENERAL. ABNORMAL. BLEEDING') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 043322-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DRY SKIN, COLD SORES, BLOOD PRESSURE HIGH, MENSES IRREGULAR, VAGINAL DISCHARGE, BACK PAIN, JOINT PAIN, MUSCLE SPASMS, WEAKNESS, ANEMIA, CROHN'S DISEASE, EPIDERMOLYSIS BULLOSA, DIABETES, HIGH CHOLESTEROL, HYPERLIPIDEMIA, ASTHMA, PREMATURE BABY AND ADENOMYOSIS. CURRENT WEIGHT 163LBS. CONCURRENT CONDITIONS INCLUDED HYPERTENSION, GERD, TOBACCO USE DISORDER, UTERINE BLEEDING, ABDOMINAL CRAMPS, LEIOMYOMA NOS, METRORRHAGIA, FIBROIDS AND POSTOPERATIVE INFECTION. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) UNTIL (B)(6) 2014 FOR CONTRACEPTION AS WELL AS ATROPINE, BACLOFEN FROM (B)(6) 2014 TO (B)(6) 2014, DOXEPIN FROM (B)(6) 2014 TO (B)(6) 2014, FENTANYL FROM (B)(6) 2014 TO (B)(6) 2014, HYDROMORPHONE HYDROCHLORIDE (DILAUDID) FROM (B)(6) 2014 TO (B)(6) 2016, KETOROLAC TROMETHAMINE (TORADOL), METOPROLOL SUCCINATE (TOPROL) FROM (B)(6) 2014 TO (B)(6) 2016 AND OMEPRAZOLE MAGNESIUM (PRILOSEC) FROM (B)(6) 2014 TO (B)(6) 2014. IN (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, DEPRESSION AND MENTAL ANGUISH/ PSYCH INJURY") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, DEPRESSION AND MENTAL ANGUIS/ PSYCH INJURY,"). IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/ LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND INTERMENSTRUAL BLEEDING ("METORHAGIA (BLEEDING B/W PERIODS)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN AND INTERMENSTRUAL BLEEDING HAD RESOLVED AND THE SALPINGITIS, DEPRESSION, ANXIETY, MIGRAINE, NAUSEA, VAGINAL DISCHARGE, FATIGUE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, INTERMENSTRUAL BLEEDING, MIGRAINE, NAUSEA, PELVIC PAIN, SALPINGITIS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE, IT WAS GIVEN (B)(6) 2014 INITIALLY, BUT IN CURRENT PFS (B)(6) 2014 WAS GIVEN. CURRENT WEIGHT 163LBS. 3 TRAILING COILS WERE VISIBLE (LEFT). 5 TRAILING COILS WERE VISIBLE (RIGHT). PATIENT RECEIVED TREATMENT FOR PELVIC/ ABDOMINAL, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING),METORHAGIA (BLEEDING B/W PERIODS),GENERAL. ABNORMAL. BLEEDING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 73.469 KGS. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.; ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION THE FALLOPIAN TUBES WERE BLOCKED. PREGNANCY TEST - ON (B)(6) 2014: NEGATIVE. ULTRASOUND SCAN - ON (B)(6) 2014: INTRAMURAL FIBROID VS ENDOMETRIAL POLYP MEASURING 3.1 X 304 CM, RT OVARY APPEARS WNL, LT OVARY SEEN WITH MULTIPLE PERIPHERAL FOLLICLES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING: FATIGUE, MENORRHAGIA, ANXIETY, DYSMENORRHEA, ACUTE AND CHRONIC SALPINGITIS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-MAY-2021: MR RECEIVED. REPORTER INFORMATION, PATIENT MEDICAL HISTORY, EVENT: ACUTE AND CHRONIC SALPINGITIS 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 PELVIC PAIN ('PLAINTIFF HAS SUFFERED PHYSICAL PAIN'), SALPINGITIS ('ACUTE AND CHRONIC SALPINGITIS') AND GENITAL HAEMORRHAGE ('GENERAL. ABNORMAL. BLEEDING') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 043322-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DRY SKIN, COLD SORES, BLOOD PRESSURE HIGH, MENSES IRREGULAR, VAGINAL DISCHARGE, BACK PAIN, JOINT PAIN, MUSCLE SPASMS, WEAKNESS, ANEMIA, CROHN'S DISEASE, EPIDERMOLYSIS BULLOSA, DIABETES, HIGH CHOLESTEROL, HYPERLIPIDEMIA, ASTHMA, PREMATURE BABY AND ADENOMYOSIS. CURRENT WEIGHT 163LBS. CONCURRENT CONDITIONS INCLUDED HYPERTENSION, GERD, TOBACCO USE DISORDER, UTERINE BLEEDING, ABDOMINAL CRAMPS, LEIOMYOMA NOS, METRORRHAGIA, FIBROIDS AND POSTOPERATIVE INFECTION. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) UNTIL (B)(6) 2014 FOR CONTRACEPTION AS WELL AS ATROPINE, BACLOFEN FROM (B)(6) 2014 TO (B)(6) 2014, DOXEPIN FROM (B)(6) 2014 TO (B)(6) 2014, FENTANYL FROM (B)(6) 2014 TO (B)(6) 2014, HYDROMORPHONE HYDROCHLORIDE (DILAUDID) FROM (B)(6) 2014 TO (B)(6) 2016, KETOROLAC TROMETHAMINE (TORADOL), METOPROLOL SUCCINATE (TOPROL) FROM (B)(6) 2014 TO (B)(6) 2016 AND OMEPRAZOLE MAGNESIUM (PRILOSEC) FROM (B)(6) 2014 TO (B)(6) 2014. IN (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, DEPRESSION AND MENTAL ANGUISH/ PSYCH INJURY") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, DEPRESSION AND MENTAL ANGUIS/ PSYCH INJURY,"). IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/ LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND INTERMENSTRUAL BLEEDING ("METORHAGIA (BLEEDING B/W PERIODS)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN AND INTERMENSTRUAL BLEEDING HAD RESOLVED AND THE SALPINGITIS, DEPRESSION, ANXIETY, MIGRAINE, NAUSEA, VAGINAL DISCHARGE, FATIGUE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, INTERMENSTRUAL BLEEDING, MIGRAINE, NAUSEA, PELVIC PAIN, SALPINGITIS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE, IT WAS GIVEN (B)(6)2014 INITIALLY, BUT IN CURRENT PFS (B)(6) 2014 WAS GIVEN. CURRENT WEIGHT 163LBS. 3 TRAILING COILS WERE VISIBLE (LEFT). 5 TRAILING COILS WERE VISIBLE (RIGHT). PATIENT RECEIVED TREATMENT FOR PELVIC/ ABDOMINAL, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), METORHAGIA (BLEEDING B/W PERIODS), GENERAL. ABNORMAL. BLEEDING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 73.469 KGS. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.; ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION. THE FALLOPIAN TUBES WERE BLOCKED. PREGNANCY TEST - ON (B)(6) 2014: NEGATIVE. ULTRASOUND SCAN - ON (B)(6) 2014: INTRAMURAL FIBROID VS ENDOMETRIAL POLYP MEASURING 3.1 X 304 CM, RT OVARY APPEARS WNL, LT OVARY SEEN WITH MULTIPLE PERIPHERAL FOLLICLES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING: FATIGUE, MENORRHAGIA, ANXIETY, DYSMENORRHEA, ACUTE AND CHRONIC SALPINGITIS. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: QUALITY-SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS 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 PELVIC PAIN ('PLAINTIFF HAS SUFFERED PHYSICAL PAIN') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 043322-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DRY SKIN, COLD SORES, BLOOD PRESSURE HIGH, MENSES IRREGULAR, VAGINAL DISCHARGE, BACK PAIN, JOINT PAIN, MUSCLE SPASMS, WEAKNESS, ANEMIA, CROHN'S DISEASE, EPIDERMOLYSIS BULLOSA, DIABETES, HIGH CHOLESTEROL, HYPERLIPIDEMIA, ASTHMA AND PREMATURE BABY. CURRENT WEIGHT 163LBS. CONCURRENT CONDITIONS INCLUDED HYPERTENSION, GERD, TOBACCO USE DISORDER, UTERINE BLEEDING, ABDOMINAL CRAMPS, LEIOMYOMA NOS, METRORRHAGIA, FIBROIDS AND POSTOPERATIVE INFECTION. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) UNTIL (B)(6)2014 FOR CONTRACEPTION AS WELL AS ATROPINE, BACLOFEN FROM (B)(6)2014 TO (B)(6)2014, DOXEPIN FROM (B)(6)2014 TO (B)(6)2014, FENTANYL FROM (B)(6)2014 TO (B)(6)2014, HYDROMORPHONE HYDROCHLORIDE (DILAUDID) FROM (B)(6)2014 TO (B)(6)2016, KETOROLAC TROMETHAMINE (TORADOL), METOPROLOL SUCCINATE (TOPROL) FROM (B)(6)2014 TO (B)(6)2016 AND OMEPRAZOLE MAGNESIUM (PRILOSEC) FROM (B)(6)2014 TO (B)(6)2014. IN (B)(6)2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2014, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, DEPRESSION AND MENTAL ANGUISH,") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, DEPRESSION AND MENTAL ANGUISH,"). IN (B)(6)2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/ LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, MIGRAINE, NAUSEA, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE, IT WAS GIVEN (B)(6)2014 INITIALLY, BUT IN CURRENT PFS (B)(6)2014 WAS GIVEN. CURRENT WEIGHT 163LBS. 3 TRAILING COILS WERE VISIBLE (LEFT). 5 TRAILING COILS WERE VISIBLE (RIGHT). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 73.469 KGS. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.; ON (B)(6)2014: TOTAL BILATERAL OCCLUSION THE FALLOPIAN TUBES WERE BLOCKED. PREGNANCY TEST - ON (B)(6)2014: NEGATIVE. ULTRASOUND SCAN - ON (B)(6)2014: INTRAMURAL FIBROID VS ENDOMETRIAL POLYP MEASURING 3.1 X 304 CM, RT OVARY APPEARS WNL, LT OVARY SEEN WITH MULTIPLE PERIPHERAL FOLLICLES,. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING: FATIGUE, MENORRHAGIA, ANXIETY, DYSMENORRHEA . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-AUG-2019: UPDATE OF INFORMATION (BATCH IS INVALID). INCIDENT: NO VALID LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 PELVIC PAIN ('PLAINTIFF HAS SUFFERED PHYSICAL PAIN') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 043322) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DRY SKIN, COLD SORES, BLOOD PRESSURE HIGH, MENSES IRREGULAR, VAGINAL DISCHARGE, BACK PAIN, JOINT PAIN, MUSCLE SPASMS, WEAKNESS, ANEMIA, CROHN'S DISEASE, EPIDERMOLYSIS BULLOSA, DIABETES, HIGH CHOLESTEROL, HYPERLIPIDEMIA, ASTHMA AND PREMATURE BABY. CURRENT WEIGHT 163LBS. CONCURRENT CONDITIONS INCLUDED HYPERTENSION, GERD, TOBACCO USE DISORDER, UTERINE BLEEDING, ABDOMINAL CRAMPS, LEIOMYOMA, METRORRHAGIA, FIBROIDS AND POSTOPERATIVE INFECTION. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) UNTIL (B)(6) 2014 FOR CONTRACEPTION AS WELL AS ATROPINE, BACLOFEN FROM (B)(6) 2014 TO (B)(6) 2014, DOXEPIN FROM (B)(6) 2014 TO (B)(6) 2014, FENTANYL FROM (B)(6) 2014 TO (B)(6) 2014, HYDROMORPHONE HYDROCHLORIDE (DILAUDID) FROM (B)(6) 2014 TO (B)(6) 2016, KETOROLAC TROMETHAMINE (TORADOL), METOPROLOL SUCCINATE (TOPROL) FROM (B)(6) 2014 TO (B)(6) 2016 AND OMEPRAZOLE MAGNESIUM (PRILOSEC) FROM (B)(6) 2014 TO (B)(6) 2014. IN (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, DEPRESSION AND MENTAL ANGUISH,") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, DEPRESSION AND MENTAL ANGUISH,"). IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MIGRAINE ("MIGRAINES/HEADACHES"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, MIGRAINE, NAUSEA, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE, IT WAS GIVEN (B)(6) 2014 INITIALLY, BUT IN CURRENT PFS (B)(6) 2014 WAS GIVEN. CURRENT WEIGHT (B)(6). 3 TRAILING COILS WERE VISIBLE (LEFT). 5 TRAILING COILS WERE VISIBLE (RIGHT). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 73.469 KGS. HYSTEROSALPINGOGRAM ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.; ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION THE FALLOPIAN TUBES WERE BLOCKED. PREGNANCY TEST ON (B)(6) 2014: NEGATIVE. ULTRASOUND SCAN ON (B)(6) 2014: INTRAMURAL FIBROID VS ENDOMETRIAL POLYP MEASURING 3.1 X 304 CM, RT OVARY APPEARS WNL, LT OVARY SEEN WITH MULTIPLE PERIPHERAL FOLLICLES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING: FATIGUE, MENORRHAGIA, ANXIETY, DYSMENORRHEA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS & MR RECEIVED: CASE BECAME INCIDENT. LOT NUMBER, EVENTS ONSET DATE AND DATE OF REMOVAL WERE ADDED. NEW EVENTS- MENORRHAGIA, VAGINAL BLEEDING,DYSMENORRHEA, DYSPAREUNIA, DEPRESSION AND MENTAL ANGUISH, MIGRAINES, NAUSEA, VAGINAL DISCHARGE, FATIGUE, WEIGHT GAIN WERE ADDED. UPDATED OUTCOME OF EVENT PELVIC PAIN TO RECOVERING/RESOLVING. REPORTERS, PATIENTS DOB, LAB DATA, MEDICAL HISTORY, CONCOMITANT CONDITION AND DRUGS WERE 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 726196 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 043322-NOT VALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Other| R | ATROPINE| ATROPINE| ATROPINE| ATROPINE| ATROPINE| BACLOFEN| BACLOFEN| BACLOFEN| BACLOFEN| BACLOFEN| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DILAUDID| DILAUDID| DILAUDID| DILAUDID| DILAUDID| DOXEPIN| DOXEPIN| DOXEPIN| DOXEPIN| DOXEPIN| FENTANYL| FENTANYL| FENTANYL| FENTANYL| FENTANYL| PRILOSEC [OMEPRAZOLE MAGNESIUM]| PRILOSEC [OMEPRAZOLE MAGNESIUM]| PRILOSEC [OMEPRAZOLE MAGNESIUM]| PRILOSEC [OMEPRAZOLE MAGNESIUM]| PRILOSEC [OMEPRAZOLE MAGNESIUM]| TOPROL| TOPROL| TOPROL| TOPROL| TOPROL| TORADOL| TORADOL| TORADOL| TORADOL| TORADOL |