ESSURE
Report
- Report Number
- 2951250-2017-07780
- Event Type
- Injury
- Date Received
- November 23, 2017
- Report Date
- April 22, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("MISCARRIAGE PREGNANCY (STILLBIRTH OR MISCARRIAGE)") AND ABORTION SPONTANEOUS ("MISCARRIAGE") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841534) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED VITAMIN D [VITAMIN D NOS]. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE/FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S)". THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2, MORNING SICKNESS, BLOOD PRESSURE HIGH, MISCARRIAGE, ABDOMINAL PAIN, UTERINE FIBROID, GI INFECTION AND OBESITY. SHE DENIES ANY RECENT FEVER OR CHILLS. CONCOMITANT PRODUCTS INCLUDED BETACAROTENE;BIOFLAVONOIDS;BIOTIN;CALCIUM ASCORBATE;CALCIUM PANTOTHENATE;CALCIUM PHOSPHATE;CHOLINE BITARTRATE;CHROMIC CHLORIDE;CHOLECALCIFEROL;COPPER SULFATE;CYANOCOBALAMIN;FOLIC ACID;HESPERIDIN;INOSITOL;IRON AMINO ACID CHELATE;LYCOPENE;LYSINE HYDROCHLORIDE;MAGNESIUM OXIDE;MANGANESE SULFATE;MOLYBDENUM TRIOXIDE;NICOTINAMIDE;PHYTOMENADIONE;POTASSIUM IODIDE;POTASSIUM SULFATE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;SELENOMETHIONINE;SILICON DIOXIDE, COLLOIDAL;SODIUM BORATE DECAHYDRATE;THIAMINE MONONITRATE;TOCOPHERYL ACID SUCCINATE;UBIDECARENONE;ZINC OXIDE (MULTIVITAMIN & MINERAL), FISH OIL AND MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA). ON AN UNKNOWN DATE, THE PATIENT STARTED VITAMIN D [VITAMIN D NOS] AT AN UNSPECIFIED DOSE AND FREQUENCY. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN"), AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS"), CONFUSIONAL STATE ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: CONFUSION"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2014, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HYPERSENSITIVITY ("ALLERGIC REACTION"), MIGRAINE ("MIGRAINES"), NAUSEA ("NAUSEA"), DEVICE EXPULSION ("IT COULD HAVE EXPELLED, MINE DID"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN") AND UTERINE CYST ("UTERINE CYST"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE/HYSTERECTOMY (FULL)/SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, HYPERSENSITIVITY, MIGRAINE, NAUSEA, DEVICE EXPULSION, FATIGUE, ABDOMINAL PAIN LOWER AND UTERINE CYST OUTCOME WAS UNKNOWN, THE PELVIC PAIN AND DYSPAREUNIA HAD RESOLVED AND THE AMNESIA, CONFUSIONAL STATE AND WEIGHT INCREASED WAS RESOLVING. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 4, PARA 2. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ABORTION SPONTANEOUS, AMNESIA, CONFUSIONAL STATE, DEVICE EXPULSION, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, MIGRAINE, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, UTERINE CYST AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CROSS REFERENCED WITH PLAINTIFF CASE NUMBER : (B)(4) ONE TUBE WAS SHAPED DIFFERENT SO IT TOOK LONGER TO GET DEVICE PLACED. CURRENT WEIGHT 205 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 36.4 KG/SQM. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD; VAGINAL BLEEDING, PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: QUALITY-SAFETY EVALUATION OF PTC. INCIDENT: WE RECEIVED A LOT NUMBER. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCE'S DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("MISCARRIAGE PREGNANCY (STILLBIRTH OR MISCARRIAGE)") AND ABORTION SPONTANEOUS ("MISCARRIAGE") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841534) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED VITAMIN D [VITAMIN D NOS]. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE/FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S)". THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2, MORNING SICKNESS, BLOOD PRESSURE HIGH, MISCARRIAGE, ABDOMINAL PAIN, UTERINE FIBROID, GI INFECTION AND OBESITY. SHE DENIES ANY RECENT FEVER OR CHILLS. CONCOMITANT PRODUCTS INCLUDED BETACAROTENE;BIOFLAVONOIDS;BIOTIN;CALCIUM ASCORBATE;CALCIUM PANTOTHENATE;CALCIUM PHOSPHATE;CHOLINE BITARTRATE;CHROMIC CHLORIDE;COLECALCIFEROL;COPPER SULFATE;CYANOCOBALAMIN;FOLIC ACID;HESPERIDIN;INOSITOL;IRON AMINO ACID CHELATE;LYCOPENE;LYSINE HYDROCHLORIDE;MAGNESIUM OXIDE;MANGANESE SULFATE;MOLYBDENUM TRIOXIDE;NICOTINAMIDE;PHYTOMENADIONE;POTASSIUM IODIDE;POTASSIUM SULFATE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;SELENOMETHIONINE;SILICON DIOXIDE, COLLOIDAL;SODIUM BORATE DECAHYDRATE;THIAMINE MONONITRATE;TOCOPHERYL ACID SUCCINATE;UBIDECARENONE;ZINC OXIDE (MULTIVITAMIN & MINERAL), FISH OIL AND MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA). ON AN UNKNOWN DATE, THE PATIENT STARTED VITAMIN D [VITAMIN D NOS] AT AN UNSPECIFIED DOSE AND FREQUENCY. ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN JANUARY 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN"), AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS"), CONFUSIONAL STATE ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: CONFUSION"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). IN MARCH 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN SEPTEMBER 2014, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HYPERSENSITIVITY ("ALLERGIC REACTION"), MIGRAINE ("MIGRAINES"), NAUSEA ("NAUSEA"), DEVICE EXPULSION ("IT COULD HAVE EXPELLED, MINE DID"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN") AND UTERINE CYST ("UTERINE CYST"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE/HYSTERECTOMY (FULL)/SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, HYPERSENSITIVITY, MIGRAINE, NAUSEA, DEVICE EXPULSION, FATIGUE, ABDOMINAL PAIN LOWER AND UTERINE CYST OUTCOME WAS UNKNOWN, THE PELVIC PAIN AND DYSPAREUNIA HAD RESOLVED AND THE AMNESIA, CONFUSIONAL STATE AND WEIGHT INCREASED WAS RESOLVING. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 4, PARA 2. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ABORTION SPONTANEOUS, AMNESIA, CONFUSIONAL STATE, DEVICE EXPULSION, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, MIGRAINE, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, UTERINE CYST AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CROSS REFERENCED WITH PLAINTIFF CASE NUMBER : (B)(4). ONE TUBE WAS SHAPED DIFFERENT SO IT TOOK LONGER TO GET DEVICE PLACED. CURRENT WEIGHT 205 LBS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 36.4 KG/SQM. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD; VAGINAL BLEEDING, PELVIC PAIN MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON(B)(6)2018: PFS RECEIVED EVENT " MEMORY LOSS/CONFUSION, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FATIGUE, WEIGHT GAIN, UTERINE CYST PELVIC PAIN, SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST" WERE ADDED. OUTCOME OF EVENT " PAIN, DYSPAREUNIA, MEMORY LOSS, CONFUSION " WERE UPDATED AS RECOVERED. AND WEIGHT GAIN WAS UPDATED AS RECOVERED. CONCOMITANT DRUG WERE ADDED. MEDICAL HISTORY WAS ADDED. LOT NUMBER, REPORTER INFORMATION, PATIENT INFORMATION WERE ADDED. INCIDENT WE RECEIVED A LOT NUMBER. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("MISCARRIAGE") AND ABORTION SPONTANEOUS ("MISCARRIAGE") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PAIN ("PAIN"), HYPERSENSITIVITY ("ALLERGIC REACTION"), MIGRAINE ("MIGRAINES"), NAUSEA ("NAUSEA") AND DEVICE EXPULSION ("IT COULD HAVE EXPELLED, MINE DID"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, PAIN, HYPERSENSITIVITY, MIGRAINE, NAUSEA AND DEVICE EXPULSION OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, DEVICE EXPULSION, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, MIGRAINE, NAUSEA, PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CROSS REFERENCED WITH PLAINTIFF CASE NUMBER : (B)(4). MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-JUN-2018: INFORMATION FROM PFS: NEW REPORTERS ADDED. NEW EVENT ADDED: IT COULD HAVE EXPELLED, MINE DID. 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 GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('MISCARRIAGE PREGNANCY (STILLBIRTH OR MISCARRIAGE)') AND ABORTION SPONTANEOUS ('MISCARRIAGE') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841534) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE/FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S)". THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2, MORNING SICKNESS, BLOOD PRESSURE HIGH, MISCARRIAGE, ABDOMINAL PAIN, UTERINE FIBROID, GI INFECTION AND OBESITY. SHE DENIES ANY RECENT FEVER OR CHILLS. CONCOMITANT PRODUCTS INCLUDED BETACAROTENE;BIOFLAVONOIDS NOS;BIOTIN;CALCIUM ASCORBATE;CALCIUM PANTOTHENATE;CALCIUM PHOSPHATE;CHOLINE BITARTRATE;CHROMIC CHLORIDE;COLECALCIFEROL;COPPER SULFATE;CYANOCOBALAMIN;FOLIC ACID;HESPERIDIN;INOSITOL;IRON AMINO ACID CHELATE;LYCOPENE;LYSINE HYDROCHLORIDE;MAGNESIUM OXIDE;MANGANESE SULFATE;MOLYBDENUM TRIOXIDE;NICOTINAMIDE;PHYTOMENADIONE;POTASSIUM IODIDE;POTASSIUM SULFATE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;SELENOMETHIONINE;SILICON DIOXIDE, COLLOIDAL;SODIUM BORATE DECAHYDRATE;THIAMINE MONONITRATE;TOCOPHERYL ACID SUCCINATE;UBIDECARENONE;ZINC OXIDE (MULTIVITAMIN & MINERAL), DROSPIRENONE + ETHINYLESTRADIOL (YAZ), FISH OIL, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND VITAMIN D NOS (VITAMIN D). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN"), AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS"), CONFUSIONAL STATE ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: CONFUSION"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN, SHE COULDN'T LOSE WEIGHT"). IN (B)(6) 2014, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ALLERGY TO METALS ("ALLERGIC REACTION: METAL ALLERGY"), MIGRAINE ("MIGRAINES"), NAUSEA ("NAUSEA"), DEVICE EXPULSION ("IT COULD HAVE EXPELLED, MINE DID"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), UTERINE CYST ("UTERINE CYST"), LOSS OF LIBIDO ("SHE HAD ESSURE MY SEX DRIVE WAS ZILCH"), PAIN ("SHE HAD EVERYDAY ALL DAY ACHINESS/ STABBING JUST OVER ALL PAIN"), PHOTOSENSITIVITY REACTION ("FEELING LIKE SHE GOT SUN POISONING"), GASTRITIS BACTERIAL ("SHE HAVE BEEN HAVING STOMACH PROBLEMS, SHE HAD FIGHTING A STOMACH BACTERIAL INFECTION"), ERYTHEMA ("HER FACE WAS BEAT RED"), BLADDER SPASM ("SHE HAVING A SQUEEZING FEELING WHILE URINATING AND DOCTOR SAID IT WAS BLADDER SPASM."), ABDOMINAL DISTENSION ("BELLY SWELLING"), PERIPHERAL SWELLING ("HER LEFT LEG WAS SWOLLEN"), DEPRESSION ("SHE HAD DEPRESSION"), ANXIETY ("ANXIETY"), POST-TRAUMATIC STRESS DISORDER ("PTSD"), MENSTRUATION IRREGULAR ("SHE HAVE BEEN HAVING IRREGULAR PERIODS"), SLEEP APNOEA SYNDROME ("SLEEP APNEA"), BACK PAIN ("BACK PAIN"), ARTHRALGIA ("HIP PAIN"), CONSTIPATION ("CONSTIPATION"), DIZZINESS ("SHE FEEL LIKE LIGHTHEADED"), NASOPHARYNGITIS ("SHE GET BETTER FROM A COLD") AND CARPAL TUNNEL SYNDROME ("SHE PUT ON SOME CARPEL TUNNEL BRACE AND SWELLING WENT DOWN") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("SHE HAD A UTERINE FIBROID"), VITAMIN D DECREASED ("THEIR VITAMIN D WAS REALLY LOW") AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE/HYSTERECTOMY (FULL)/SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, ALLERGY TO METALS, MIGRAINE, NAUSEA, DEVICE EXPULSION, FATIGUE, ABDOMINAL PAIN LOWER, UTERINE CYST, LOSS OF LIBIDO, PAIN, PHOTOSENSITIVITY REACTION, UTERINE LEIOMYOMA, GASTRITIS BACTERIAL, ERYTHEMA, BLADDER SPASM, ABDOMINAL DISTENSION, PERIPHERAL SWELLING, VITAMIN D DECREASED, HORMONE LEVEL ABNORMAL, DEPRESSION, ANXIETY, POST-TRAUMATIC STRESS DISORDER, MENSTRUATION IRREGULAR, SLEEP APNOEA SYNDROME, BACK PAIN, ARTHRALGIA, CONSTIPATION, DIZZINESS, NASOPHARYNGITIS AND CARPAL TUNNEL SYNDROME OUTCOME WAS UNKNOWN, THE PELVIC PAIN AND DYSPAREUNIA HAD RESOLVED AND THE AMNESIA, CONFUSIONAL STATE AND WEIGHT INCREASED WAS RESOLVING. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 4, PARA 2. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ABORTION SPONTANEOUS, ALLERGY TO METALS, AMNESIA, ANXIETY, ARTHRALGIA, BACK PAIN, BLADDER SPASM, CARPAL TUNNEL SYNDROME, CONFUSIONAL STATE, CONSTIPATION, DEPRESSION, DEVICE EXPULSION, DIZZINESS, DYSPAREUNIA, ERYTHEMA, FATIGUE, GASTRITIS BACTERIAL, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, LOSS OF LIBIDO, MENSTRUATION IRREGULAR, MIGRAINE, NASOPHARYNGITIS, NAUSEA, PAIN, PELVIC PAIN, PERIPHERAL SWELLING, PHOTOSENSITIVITY REACTION, POST-TRAUMATIC STRESS DISORDER, PREGNANCY WITH CONTRACEPTIVE DEVICE, SLEEP APNOEA SYNDROME, UTERINE CYST, UTERINE LEIOMYOMA, VITAMIN D DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CROSS REFERENCED WITH PLAINTIFF CASE NUMBER : (B)(4). ONE TUBE WAS SHAPED DIFFERENT SO IT TOOK LONGER TO GET DEVICE PLACED. CURRENT WEIGHT 205 LBS . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 36.4 KG/SQM. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD; VAGINAL BLEEDING, PELVIC PAIN. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S SOCIAL MEDIA "SHE HAD ESSURE MY SEX DRIVE WAS ZILCH, SHE HAD EVERYDAY ALL DAY ACHINESS/ STABBING JUST OVER ALL PAIN, FEELING LIKE SHE GOT SUN POISONING, SHE HAD A UTERINE FIBROID, SHE HAVE BEEN HAVING STOMACH PROBLEMS, SHE HAD FIGHTING A STOMACH BACTERIAL INFECTION, HER FACE WAS BEAT RED, SHE HAVING A SQUEEZING FEELING WHILE URINATING AND DOCTOR SAID IT WAS BLADDER SPASM, BELLY SWELLING, HER LEFT LEG WAS SWOLLEN, THEIR VITAMIN D WAS REALLY LOW, HORMONAL CHANGES, SHE HAD DEPRESSION, ANXIETY, PTSD, SHE HAVE BEEN HAVING IRREGULAR PERIODS, SLEEP APNEA, BACK PAIN, HIP PAIN, CONSTIPATION, SHE FEEL LIKE LIGHTHEADED, SHE GET BETTER FROM A COLD, SHE PUT ON SOME CARPEL TUNNEL BRACE AND SWELLING WENT DOWN" LOT NUMBER: 841534 MANUFACTURE DATE: 2011-03 EXPIRATION DATE: 2014-03 THIS EXPIRATION DATE IS THE CORRECT. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-NOV-2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. WE RECEIVED A LOT NUMBER. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('MISCARRIAGE PREGNANCY (STILLBIRTH OR MISCARRIAGE)') AND ABORTION SPONTANEOUS ('MISCARRIAGE') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841534) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE/FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S)". THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2, MORNING SICKNESS, BLOOD PRESSURE HIGH, MISCARRIAGE, ABDOMINAL PAIN, UTERINE FIBROID, GI INFECTION AND OBESITY. SHE DENIES ANY RECENT FEVER OR CHILLS. CONCOMITANT PRODUCTS INCLUDED BETACAROTENE;BIOFLAVONOIDS NOS;BIOTIN;CALCIUM ASCORBATE;CALCIUM PANTOTHENATE;CALCIUM PHOSPHATE;CHOLINE BITARTRATE;CHROMIC CHLORIDE;COLECALCIFEROL;COPPER SULFATE;CYANOCOBALAMIN;FOLIC ACID;HESPERIDIN;INOSITOL;IRON AMINO ACID CHELATE;LYCOPENE;LYSINE HYDROCHLORIDE;MAGNESIUM OXIDE;MANGANESE SULFATE;MOLYBDENUM TRIOXIDE;NICOTINAMIDE;PHYTOMENADIONE;POTASSIUM IODIDE;POTASSIUM SULFATE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;SELENOMETHIONINE;SILICON DIOXIDE, COLLOIDAL;SODIUM BORATE DECAHYDRATE;THIAMINE MONONITRATE;TOCOPHERYL ACID SUCCINATE;UBIDECARENONE;ZINC OXIDE (MULTIVITAMIN & MINERAL), DROSPIRENONE + ETHINYLESTRADIOL (YAZ), FISH OIL, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND VITAMIN D NOS (VITAMIN D). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN JANUARY 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN"), AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS"), CONFUSIONAL STATE ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: CONFUSION"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). IN MARCH 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN, SHE COULDN'T LOSE WEIGHT"). IN SEPTEMBER 2014, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ALLERGY TO METALS ("ALLERGIC REACTION: METAL ALLERGY"), MIGRAINE ("MIGRAINES"), NAUSEA ("NAUSEA"), DEVICE EXPULSION ("IT COULD HAVE EXPELLED, MINE DID"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), UTERINE CYST ("UTERINE CYST"), LOSS OF LIBIDO ("SHE HAD ESSURE MY SEX DRIVE WAS ZILCH"), PAIN ("SHE HAD EVERYDAY ALL DAY ACHINESS/ STABBING JUST OVER ALL PAIN"), PHOTOSENSITIVITY REACTION ("FEELING LIKE SHE GOT SUN POISONING"), GASTRITIS BACTERIAL ("SHE HAVE BEEN HAVING STOMACH PROBLEMS, SHE HAD FIGHTING A STOMACH BACTERIAL INFECTION"), ERYTHEMA ("HER FACE WAS BEAT RED"), BLADDER SPASM ("SHE HAVING A SQUEEZING FEELING WHILE URINATING AND DOCTOR SAID IT WAS BLADDER SPASM."), ABDOMINAL DISTENSION ("BELLY SWELLING"), PERIPHERAL SWELLING ("HER LEFT LEG WAS SWOLLEN"), DEPRESSION ("SHE HAD DEPRESSION"), ANXIETY ("ANXIETY"), POST-TRAUMATIC STRESS DISORDER ("PTSD"), MENSTRUATION IRREGULAR ("SHE HAVE BEEN HAVING IRREGULAR PERIODS"), SLEEP APNOEA SYNDROME ("SLEEP APNEA"), BACK PAIN ("BACK PAIN"), ARTHRALGIA ("HIP PAIN"), CONSTIPATION ("CONSTIPATION"), DIZZINESS ("SHE FEEL LIKE LIGHTHEADED"), NASOPHARYNGITIS ("SHE GET BETTER FROM A COLD") AND CARPAL TUNNEL SYNDROME ("SHE PUT ON SOME CARPEL TUNNEL BRACE AND SWELLING WENT DOWN") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("SHE HAD A UTERINE FIBROID"), VITAMIN D DECREASED ("THEIR VITAMIN D WAS REALLY LOW") AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE/HYSTERECTOMY (FULL)/SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, ALLERGY TO METALS, MIGRAINE, NAUSEA, DEVICE EXPULSION, FATIGUE, ABDOMINAL PAIN LOWER, UTERINE CYST, LOSS OF LIBIDO, PAIN, PHOTOSENSITIVITY REACTION, UTERINE LEIOMYOMA, GASTRITIS BACTERIAL, ERYTHEMA, BLADDER SPASM, ABDOMINAL DISTENSION, PERIPHERAL SWELLING, VITAMIN D DECREASED, HORMONE LEVEL ABNORMAL, DEPRESSION, ANXIETY, POST-TRAUMATIC STRESS DISORDER, MENSTRUATION IRREGULAR, SLEEP APNOEA SYNDROME, BACK PAIN, ARTHRALGIA, CONSTIPATION, DIZZINESS, NASOPHARYNGITIS AND CARPAL TUNNEL SYNDROME OUTCOME WAS UNKNOWN, THE PELVIC PAIN AND DYSPAREUNIA HAD RESOLVED AND THE AMNESIA, CONFUSIONAL STATE AND WEIGHT INCREASED WAS RESOLVING. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 4, PARA 2. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ABORTION SPONTANEOUS, ALLERGY TO METALS, AMNESIA, ANXIETY, ARTHRALGIA, BACK PAIN, BLADDER SPASM, CARPAL TUNNEL SYNDROME, CONFUSIONAL STATE, CONSTIPATION, DEPRESSION, DEVICE EXPULSION, DIZZINESS, DYSPAREUNIA, ERYTHEMA, FATIGUE, GASTRITIS BACTERIAL, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, LOSS OF LIBIDO, MENSTRUATION IRREGULAR, MIGRAINE, NASOPHARYNGITIS, NAUSEA, PAIN, PELVIC PAIN, PERIPHERAL SWELLING, PHOTOSENSITIVITY REACTION, POST-TRAUMATIC STRESS DISORDER, PREGNANCY WITH CONTRACEPTIVE DEVICE, SLEEP APNOEA SYNDROME, UTERINE CYST, UTERINE LEIOMYOMA, VITAMIN D DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CROSS REFERENCED WITH PLAINTIFF CASE NUMBER : 2017-216881 ONE TUBE WAS SHAPED DIFFERENT SO IT TOOK LONGER TO GET DEVICE PLACED. CURRENT WEIGHT 205 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 36.4 KG/SQM. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD; VAGINAL BLEEDING, PELVIC PAIN. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S SOCIAL MEDIA "SHE HAD ESSURE MY SEX DRIVE WAS ZILCH, SHE HAD EVERYDAY ALL DAY ACHINESS/ STABBING JUST OVER ALL PAIN, FEELING LIKE SHE GOT SUN POISONING, SHE HAD A UTERINE FIBROID, SHE HAVE BEEN HAVING STOMACH PROBLEMS, SHE HAD FIGHTING A STOMACH BACTERIAL INFECTION, HER FACE WAS BEAT RED, SHE HAVING A SQUEEZING FEELING WHILE URINATING AND DOCTOR SAID IT WAS BLADDER SPASM, BELLY SWELLING, HER LEFT LEG WAS SWOLLEN, THEIR VITAMIN D WAS REALLY LOW, HORMONAL CHANGES, SHE HAD DEPRESSION, ANXIETY, PTSD, SHE HAVE BEEN HAVING IRREGULAR PERIODS, SLEEP APNEA, BACK PAIN, HIP PAIN, CONSTIPATION, SHE FEEL LIKE LIGHTHEADED, SHE GET BETTER FROM A COLD, SHE PUT ON SOME CARPEL TUNNEL BRACE AND SWELLING WENT DOWN" QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: CODING REQUEST: REP = SHE GET BETTER FROM A COLD, THIS EVENT WAS RECODED TO COMMON COLD. INCIDENT: WE RECEIVED A LOT NUMBER. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('MISCARRIAGE PREGNANCY (STILLBIRTH OR MISCARRIAGE)') AND ABORTION SPONTANEOUS ('MISCARRIAGE') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841534) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE/FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S)". THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2, MORNING SICKNESS, BLOOD PRESSURE HIGH, MISCARRIAGE, ABDOMINAL PAIN, UTERINE FIBROID, GI INFECTION AND OBESITY. SHE DENIES ANY RECENT FEVER OR CHILLS. CONCOMITANT PRODUCTS INCLUDED BETACAROTENE;BIOFLAVONOIDS NOS;BIOTIN;CALCIUM ASCORBATE;CALCIUM PANTOTHENATE;CALCIUM PHOSPHATE;CHOLINE BITARTRATE;CHROMIC CHLORIDE;COLECALCIFEROL;COPPER SULFATE;CYANOCOBALAMIN;FOLIC ACID;HESPERIDIN;INOSITOL;IRON AMINO ACID CHELATE;LYCOPENE;LYSINE HYDROCHLORIDE;MAGNESIUM OXIDE;MANGANESE SULFATE;MOLYBDENUM TRIOXIDE;NICOTINAMIDE;PHYTOMENADIONE;POTASSIUM IODIDE;POTASSIUM SULFATE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;SELENOMETHIONINE;SILICON DIOXIDE, COLLOIDAL;SODIUM BORATE DECAHYDRATE;THIAMINE MONONITRATE;TOCOPHERYL ACID SUCCINATE;UBIDECARENONE;ZINC OXIDE (MULTIVITAMIN & MINERAL), DROSPIRENONE + ETHINYLESTRADIOL (YAZ), FISH OIL, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND VITAMIN D NOS (VITAMIN D). ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN"), AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS"), CONFUSIONAL STATE ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: CONFUSION"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). IN (B)(6)2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN, SHE COULDN'T LOSE WEIGHT"). IN (B)(6)2014, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ALLERGY TO METALS ("ALLERGIC REACTION: METAL ALLERGY"), MIGRAINE ("MIGRAINES"), NAUSEA ("NAUSEA"), DEVICE EXPULSION ("IT COULD HAVE EXPELLED, MINE DID"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), UTERINE CYST ("UTERINE CYST"), LOSS OF LIBIDO ("SHE HAD ESSURE MY SEX DRIVE WAS ZILCH"), PAIN ("SHE HAD EVERYDAY ALL DAY ACHINESS/ STABBING JUST OVER ALL PAIN"), PHOTOSENSITIVITY REACTION ("FEELING LIKE SHE GOT SUN POISONING"), GASTRITIS BACTERIAL ("SHE HAVE BEEN HAVING STOMACH PROBLEMS, SHE HAD FIGHTING A STOMACH BACTERIAL INFECTION"), ERYTHEMA ("HER FACE WAS BEAT RED"), BLADDER SPASM ("SHE HAVING A SQUEEZING FEELING WHILE URINATING AND DOCTOR SAID IT WAS BLADDER SPASM."), ABDOMINAL DISTENSION ("BELLY SWELLING"), PERIPHERAL SWELLING ("HER LEFT LEG WAS SWOLLEN"), DEPRESSION ("SHE HAD DEPRESSION"), ANXIETY ("ANXIETY"), POST-TRAUMATIC STRESS DISORDER ("PTSD"), MENSTRUATION IRREGULAR ("SHE HAVE BEEN HAVING IRREGULAR PERIODS"), SLEEP APNOEA SYNDROME ("SLEEP APNEA"), BACK PAIN ("BACK PAIN"), ARTHRALGIA ("HIP PAIN"), CONSTIPATION ("CONSTIPATION"), DIZZINESS ("SHE FEEL LIKE LIGHTHEADED"), FEELING COLD ("SHE GET BETTER FROM A COLD") AND CARPAL TUNNEL SYNDROME ("SHE PUT ON SOME CARPEL TUNNEL BRACE AND SWELLING WENT DOWN") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("SHE HAD A UTERINE FIBROID"), VITAMIN D DECREASED ("THEIR VITAMIN D WAS REALLY LOW") AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE/HYSTERECTOMY (FULL)/SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, ALLERGY TO METALS, MIGRAINE, NAUSEA, DEVICE EXPULSION, FATIGUE, ABDOMINAL PAIN LOWER, UTERINE CYST, LOSS OF LIBIDO, PAIN, PHOTOSENSITIVITY REACTION, UTERINE LEIOMYOMA, GASTRITIS BACTERIAL, ERYTHEMA, BLADDER SPASM, ABDOMINAL DISTENSION, PERIPHERAL SWELLING, VITAMIN D DECREASED, HORMONE LEVEL ABNORMAL, DEPRESSION, ANXIETY, POST-TRAUMATIC STRESS DISORDER, MENSTRUATION IRREGULAR, SLEEP APNOEA SYNDROME, BACK PAIN, ARTHRALGIA, CONSTIPATION, DIZZINESS, FEELING COLD AND CARPAL TUNNEL SYNDROME OUTCOME WAS UNKNOWN, THE PELVIC PAIN AND DYSPAREUNIA HAD RESOLVED AND THE AMNESIA, CONFUSIONAL STATE AND WEIGHT INCREASED WAS RESOLVING. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 4, PARA 2. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ABORTION SPONTANEOUS, ALLERGY TO METALS, AMNESIA, ANXIETY, ARTHRALGIA, BACK PAIN, BLADDER SPASM, CARPAL TUNNEL SYNDROME, CONFUSIONAL STATE, CONSTIPATION, DEPRESSION, DEVICE EXPULSION, DIZZINESS, DYSPAREUNIA, ERYTHEMA, FATIGUE, FEELING COLD, GASTRITIS BACTERIAL, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, LOSS OF LIBIDO, MENSTRUATION IRREGULAR, MIGRAINE, NAUSEA, PAIN, PELVIC PAIN, PERIPHERAL SWELLING, PHOTOSENSITIVITY REACTION, POST-TRAUMATIC STRESS DISORDER, PREGNANCY WITH CONTRACEPTIVE DEVICE, SLEEP APNOEA SYNDROME, UTERINE CYST, UTERINE LEIOMYOMA, VITAMIN D DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CROSS REFERENCED WITH PLAINTIFF CASE NUMBER : (B)(4) ONE TUBE WAS SHAPED DIFFERENT SO IT TOOK LONGER TO GET DEVICE PLACED. CURRENT WEIGHT 205 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 36.4 KG/SQM. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD; VAGINAL BLEEDING, PELVIC PAIN. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S SOCIAL MEDIA "SHE HAD ESSURE MY SEX DRIVE WAS ZILCH, SHE HAD EVERYDAY ALL DAY ACHINESS/ STABBING JUST OVER ALL PAIN, FEELING LIKE SHE GOT SUN POISONING, SHE HAD A UTERINE FIBROID, SHE HAVE BEEN HAVING STOMACH PROBLEMS, SHE HAD FIGHTING A STOMACH BACTERIAL INFECTION, HER FACE WAS BEAT RED, SHE HAVING A SQUEEZING FEELING WHILE URINATING AND DOCTOR SAID IT WAS BLADDER SPASM, BELLY SWELLING, HER LEFT LEG WAS SWOLLEN, THEIR VITAMIN D WAS REALLY LOW, HORMONAL CHANGES, SHE HAD DEPRESSION, ANXIETY, PTSD, SHE HAVE BEEN HAVING IRREGULAR PERIODS, SLEEP APNEA, BACK PAIN, HIP PAIN, CONSTIPATION, SHE FEEL LIKE LIGHTHEADED, SHE GET BETTER FROM A COLD, SHE PUT ON SOME CARPEL TUNNEL BRACE AND SWELLING WENT DOWN" QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-OCT-2019: SOCIAL MEDIA RECEIVED EVENTS "SHE HAD ESSURE MY SEX DRIVE WAS ZILCH, SHE HAD EVERYDAY ALL DAY ACHINESS/ STABBING JUST OVER ALL PAIN, FEELING LIKE SHE GOT SUN POISONING, SHE HAD A UTERINE FIBROID, SHE HAVE BEEN HAVING STOMACH PROBLEMS, SHE HAD FIGHTING A STOMACH BACTERIAL INFECTION, HER FACE WAS BEAT RED, SHE HAVING A SQUEEZING FEELING WHILE URINATING AND DOCTOR SAID IT WAS BLADDER SPASM, BELLY SWELLING, HER LEFT LEG WAS SWOLLEN, THEIR VITAMIN D WAS REALLY LOW, HORMONAL CHANGES, SHE HAD DEPRESSION, ANXIETY, PTSD, SHE HAVE BEEN HAVING IRREGULAR PERIODS, SLEEP APNEA, BACK PAIN, HIP PAIN, CONSTIPATION, SHE FEEL LIKE LIGHTHEADED, SHE GET BETTER FROM A COLD, SHE PUT ON SOME CARPEL TUNNEL BRACE AND SWELLING WENT DOWN" WERE ADDED. CONCOMITANT DRUG WAS ADDED. ON 2-OCT-2019: PFS RECEIVED : NO NEW SIGNIFICANT INFORMATION ADDED. INCIDENT: WE RECEIVED A LOT NUMBER. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING') AND ABORTION SPONTANEOUS ('MISCARRIAGE') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841534) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE/FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S)". THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2, MORNING SICKNESS, BLOOD PRESSURE HIGH, MISCARRIAGE, ABDOMINAL PAIN, UTERINE FIBROID, GI INFECTION AND OBESITY. SHE DENIES ANY RECENT FEVER OR CHILLS. CONCOMITANT PRODUCTS INCLUDED BETACAROTENE;BIOFLAVONOIDS NOS;BIOTIN;CALCIUM ASCORBATE;CALCIUM PANTOTHENATE;CALCIUM PHOSPHATE;CHOLINE BITARTRATE;CHROMIC CHLORIDE;COLECALCIFEROL;COPPER SULFATE;CYANOCOBALAMIN;FOLIC ACID;HESPERIDIN;INOSITOL;IRON AMINO ACID CHELATE;LYCOPENE;LYSINE HYDROCHLORIDE;MAGNESIUM OXIDE;MANGANESE SULFATE;MOLYBDENUM TRIOXIDE;NICOTINAMIDE;PHYTOMENADIONE;POTASSIUM IODIDE;POTASSIUM SULFATE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;SELENOMETHIONINE;SILICON DIOXIDE, COLLOIDAL;SODIUM BORATE DECAHYDRATE;THIAMINE MONONITRATE;TOCOPHERYL ACID SUCCINATE;UBIDECARENONE;ZINC OXIDE (MULTIVITAMIN & MINERAL), DROSPIRENONE + ETHINYLESTRADIOL (YAZ), FISH OIL, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND VITAMIN D NOS (VITAMIN D). ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN"), AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS"), CONFUSIONAL STATE ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: CONFUSION"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN, SHE COULDN'T LOSE WEIGHT"). IN (B)(6) 2014, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("MISCARRIAGE PREGNANCY (STILLBIRTH OR MISCARRIAGE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ALLERGY TO METALS ("ALLERGIC REACTION: METAL ALLERGY"), MIGRAINE ("MIGRAINES"), NAUSEA ("NAUSEA"), DEVICE EXPULSION ("IT COULD HAVE EXPELLED, MINE DID"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), UTERINE CYST ("UTERINE CYST"), LOSS OF LIBIDO ("SHE HAD ESSURE MY SEX DRIVE WAS ZILCH"), PAIN ("SHE HAD EVERYDAY ALL DAY ACHINESS/ STABBING JUST OVER ALL PAIN"), PHOTOSENSITIVITY REACTION ("FEELING LIKE SHE GOT SUN POISONING"), GASTRITIS BACTERIAL ("SHE HAVE BEEN HAVING STOMACH PROBLEMS, SHE HAD FIGHTING A STOMACH BACTERIAL INFECTION"), ERYTHEMA ("HER FACE WAS BEAT RED"), BLADDER SPASM ("SHE HAVING A SQUEEZING FEELING WHILE URINATING AND DOCTOR SAID IT WAS BLADDER SPASM."), ABDOMINAL DISTENSION ("BELLY SWELLING"), PERIPHERAL SWELLING ("HER LEFT LEG WAS SWOLLEN"), DEPRESSION ("SHE HAD DEPRESSION"), ANXIETY ("ANXIETY"), POST-TRAUMATIC STRESS DISORDER ("PTSD"), MENSTRUATION IRREGULAR ("SHE HAVE BEEN HAVING IRREGULAR PERIODS"), SLEEP APNOEA SYNDROME ("SLEEP APNEA"), BACK PAIN ("BACK PAIN"), ARTHRALGIA ("HIP PAIN"), CONSTIPATION ("CONSTIPATION"), DIZZINESS ("SHE FEEL LIKE LIGHTHEADED"), NASOPHARYNGITIS ("SHE GET BETTER FROM A COLD"), CARPAL TUNNEL SYNDROME ("SHE PUT ON SOME CARPEL TUNNEL BRACE AND SWELLING WENT DOWN") AND VULVOVAGINAL SWELLING ("VAGINAL SWELLING") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("SHE HAD A UTERINE FIBROID"), VITAMIN D DECREASED ("THEIR VITAMIN D WAS REALLY LOW") AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE/HYSTERECTOMY (FULL)/SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, ALLERGY TO METALS, MIGRAINE, NAUSEA, DEVICE EXPULSION, FATIGUE, ABDOMINAL PAIN LOWER, UTERINE CYST, LOSS OF LIBIDO, PAIN, PHOTOSENSITIVITY REACTION, UTERINE LEIOMYOMA, GASTRITIS BACTERIAL, ERYTHEMA, BLADDER SPASM, ABDOMINAL DISTENSION, PERIPHERAL SWELLING, VITAMIN D DECREASED, HORMONE LEVEL ABNORMAL, DEPRESSION, ANXIETY, POST-TRAUMATIC STRESS DISORDER, MENSTRUATION IRREGULAR, SLEEP APNOEA SYNDROME, BACK PAIN, ARTHRALGIA, CONSTIPATION, DIZZINESS, NASOPHARYNGITIS, CARPAL TUNNEL SYNDROME AND VULVOVAGINAL SWELLING OUTCOME WAS UNKNOWN, THE PELVIC PAIN AND DYSPAREUNIA HAD RESOLVED AND THE AMNESIA, CONFUSIONAL STATE AND WEIGHT INCREASED WAS RESOLVING. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 4, PARA 2. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ABORTION SPONTANEOUS, ALLERGY TO METALS, AMNESIA, ANXIETY, ARTHRALGIA, BACK PAIN, BLADDER SPASM, CARPAL TUNNEL SYNDROME, CONFUSIONAL STATE, CONSTIPATION, DEPRESSION, DEVICE EXPULSION, DIZZINESS, DYSPAREUNIA, ERYTHEMA, FATIGUE, GASTRITIS BACTERIAL, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, LOSS OF LIBIDO, MENSTRUATION IRREGULAR, MIGRAINE, NASOPHARYNGITIS, NAUSEA, PAIN, PELVIC PAIN, PERIPHERAL SWELLING, PHOTOSENSITIVITY REACTION, POST-TRAUMATIC STRESS DISORDER, PREGNANCY WITH CONTRACEPTIVE DEVICE, SLEEP APNOEA SYNDROME, UTERINE CYST, UTERINE LEIOMYOMA, VITAMIN D DECREASED, VULVOVAGINAL SWELLING AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CROSS REFERENCED WITH PLAINTIFF CASE NUMBER : (B)(4). ONE TUBE WAS SHAPED DIFFERENT SO IT TOOK LONGER TO GET DEVICE PLACED. CURRENT WEIGHT 205 LBS. THE PATIENT EXPERIENCED ANOTHER PREGNANCY EPISODE UNDER CASE (B)(4).. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 36.4 KG/SQM. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD; VAGINAL BLEEDING, PELVIC PAIN. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S SOCIAL MEDIA "SHE HAD ESSURE MY SEX DRIVE WAS ZILCH, SHE HAD EVERYDAY ALL DAY ACHINESS/ STABBING JUST OVER ALL PAIN, FEELING LIKE SHE GOT SUN POISONING, SHE HAD A UTERINE FIBROID, SHE HAVE BEEN HAVING STOMACH PROBLEMS, SHE HAD FIGHTING A STOMACH BACTERIAL INFECTION, HER FACE WAS BEAT RED, SHE HAVING A SQUEEZING FEELING WHILE URINATING AND DOCTOR SAID IT WAS BLADDER SPASM, BELLY SWELLING, HER LEFT LEG WAS SWOLLEN, THEIR VITAMIN D WAS REALLY LOW, HORMONAL CHANGES, SHE HAD DEPRESSION, ANXIETY, PTSD, SHE HAVE BEEN HAVING IRREGULAR PERIODS, SLEEP APNEA, BACK PAIN, HIP PAIN, CONSTIPATION, SHE FEEL LIKE LIGHTHEADED, SHE GET BETTER FROM A COLD, SHE PUT ON SOME CARPEL TUNNEL BRACE AND SWELLING WENT DOWN" LOT NUMBER: 841534, MANUFACTURE DATE: 2011-03, EXPIRATION DATE: 2014-03. THIS EXPIRATION DATE IS THE CORRECT. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2020: CONTENT RECEIVED FROM SOCIAL MEDIA: REPORTER AND EVENT,"VAGINAL SWELLING" WERE ADDED, DETAILS OF DEVICE WERE UPDATED. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("MISCARRIAGE") AND ABORTION SPONTANEOUS ("MISCARRIAGE") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PAIN ("PAIN"), HYPERSENSITIVITY ("ALLERGIC REACTION"), MIGRAINE ("MIGRAINES") AND NAUSEA ("NAUSEA"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, PAIN, HYPERSENSITIVITY, MIGRAINE AND NAUSEA OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, MIGRAINE, NAUSEA, PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. 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 |
|---|---|---|---|---|---|---|---|
| 834517 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841534 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other| R | DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| FISH OIL| FISH OIL| FISH OIL| FISH OIL| FISH OIL| FISH OIL| MULTIVITAMIN & MINERAL| MULTIVITAMIN & MINERAL| MULTIVITAMIN & MINERAL| MULTIVITAMIN & MINERAL| MULTIVITAMIN & MINERAL| MULTIVITAMIN & MINERAL| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| YAZ| YAZ| YAZ| YAZ |