ESSURE
Report
- Report Number
- 2951250-2018-04403
- Event Type
- Injury
- Date Received
- October 23, 2018
- Report Date
- September 16, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION OF THE DEVICE') IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802268-INV, B02269) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST: NO". THE PATIENT'S MEDICAL HISTORY INCLUDED MISCARRIAGE OF PREGNANCY IN (B)(6) 2019, CHOLECYSTECTOMY IN 2004, MULTI GRAVIDA, PARITY 4, EARLY MENARCHE, CHLAMYDIAL INFECTION, GONORRHEA, CHLAMYDIAL INFECTION, GONORRHEA, CHOLECYSTECTOMY IN 2004 AND LASER THERAPY (BIRTH MARK (NOSE)) IN 2002. NO KNOWN DRUG ALLERGY. SHE DOESNT DRINK ALCOHOL AND NO USE OF RECREATIONAL/STREET DRUGS. (B)(6) 2013 - MENARCHE: BEGAN AT AGE: 10. MENSTRUATION: INTERVALS: REGULAR/MONTHLY, DURATION: 7 DAYS, CHARACTER OF PERIOD: NORMAL, DYSMENORRHEA: NO, PMS SYMPTOMS PELVIC PAIN. HX OF STDS: STATUS: YES, DIAGNOSIS CHLAMYDIA, GONORRHEA 07,09. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA FROM 2009 TO 2011. CONCURRENT CONDITIONS INCLUDED NON-SMOKER, ANXIETY, PAIN, INCISION SITE HYPOAESTHESIA, INCISION SITE HAEMATOMA, SUICIDAL IDEATION, DEPRESSION AND CHOLECYSTECTOMY. FAMILY HISTORY INCLUDED HEPATITIS. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) IN 2013 FOR BIRTH CONTROL AS WELL AS TERCONAZOLE. IN 2013, THE PATIENT EXPERIENCED POLLAKIURIA ("BLADDER OR URINARY PROBLEMS OR CHANGES: FREQUENCY"). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED LIBIDO DECREASED ("HORMONAL CHANGES - DECREASED LIBIDO"). IN 2014, THE PATIENT EXPERIENCED AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS"). IN 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL CRAMPS/ DYSMENORRHOEA(CRAMPING)"), MOOD SWINGS ("MOOD SWINGS"), IRRITABILITY ("IRRITABLE"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE:BLURR") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN,"). IN 2016, THE PATIENT EXPERIENCED ARTHRALGIA ("HIP PAIN, JOINT PAIN, KNEES PAIN"), GINGIVAL BLEEDING ("DENTAL PROBLEMS, BLEEDING GUMS") AND PAIN IN EXTREMITY ("LEG PAIN"). IN 2017, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES"), ALLERGY TO METALS ("NICKEL ALLERGY") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN/CRAMPING"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VAGINAL INFECTION ("VAGINAL INFECTION"), ABDOMINAL PAIN UPPER ("UPPER ABDOMINAL PAIN"), MENORRHAGIA ("SEVERE MENSTRUAL FLOW/ BLOOD LOSS"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), BACK PAIN ("CONSTANT LOWER BACK PAIN"), NERVE INJURY ("NERVES OF LEGS AFFECTED"), DEPRESSION ("DEPRESSION") AND SUICIDE ATTEMPT ("ATTEMPTED SUICIDE"). THE PATIENT WAS TREATED WITH ASCORBIC ACID;CALCIUM GLUCONATE;CUPRIC CARBONATE, BASIC;CYANOCOBALAMIN;ERGOCALCIFEROL;FERROUS SULFATE;MANGANESE CHLORIDE;NICOTINAMIDE;POTASSIUM IODIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE (PRENATAL) AND SURGERY (SURGICAL REMOVAL OF COIL). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ABDOMINAL PAIN, VAGINAL DISCHARGE, VAGINAL INFECTION, ABDOMINAL PAIN UPPER, MENORRHAGIA, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, BACK PAIN, ARTHRALGIA, NERVE INJURY, MOOD SWINGS, IRRITABILITY, POLLAKIURIA, MIGRAINE, GINGIVAL BLEEDING, AMNESIA, DYSPAREUNIA, VISION BLURRED, WEIGHT INCREASED, ALOPECIA, ALLERGY TO METALS, LIBIDO DECREASED, PAIN IN EXTREMITY, HEADACHE, DEPRESSION AND SUICIDE ATTEMPT OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALLERGY TO METALS, ALOPECIA, AMNESIA, ARTHRALGIA, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GINGIVAL BLEEDING, HEADACHE, IRRITABILITY, LIBIDO DECREASED, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NERVE INJURY, PAIN IN EXTREMITY, POLLAKIURIA, SUICIDE ATTEMPT, VAGINAL DISCHARGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2019, THE PATIENT WAS PREPPED AND DRAPED IN A NORMAL STERILE FASHION . BOTH ESSURE DEVICES WERE COMPLETELY REMOVED. BOTH TUBES WERE IMPLANTED IN THE CORNUAL ASPECT OF THE UTERUS AFTER FISH MOUTHING THE TUBES. AFTER COILS REMOVAL ON (B)(6) 2019, PLAINTIFF HAD INCOMPLETE MISCARRIAGE. DATE(S) OF INSERTION: (B)(6) 2013 (DISCREPANCY NOTED, AS PER PFS). DATE(S) OF REMOVAL: (B)(6) 2019 (DISCREPANCY). INSERTION DETAILS-TRAILING COILS: LEFT: 1 , RIGHT: 1 . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): CHOLECYSTECTOMY - IN 2004: NO RESULTS. LOT NUMBER REPORTED 802268 IS NOT VALID. LOT NUMBER: B02269 MANUFACTURING DATE: 2013-02 EXPIRATION DATE:2016-02 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-SEP-2020: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION OF THE DEVICE') IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802268-INV, B02269) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST: NO". THE PATIENT'S MEDICAL HISTORY INCLUDED MISCARRIAGE OF PREGNANCY IN (B)(6) 2019, CHOLECYSTECTOMY IN 2004, MULTI GRAVIDA, PARITY 4, EARLY MENARCHE, CHLAMYDIAL INFECTION, GONORRHEA, CHLAMYDIAL INFECTION, GONORRHEA, CHOLECYSTECTOMY IN 2004 AND LASER THERAPY (BIRTH MARK (NOSE)) IN 2002. NO KNOWN DRUG ALLERGY. SHE DOESN'T DRINK ALCOHOL AND NO USE OF RECREATIONAL/STREET DRUGS. *(B)(6) 2013 - MENARCHE: BEGAN AT AGE: 10. MENSTRUATION: INTERVALS: REGULAR/MONTHLY, DURATION: 7 DAYS, CHARACTER OF PERIOD: NORMAL, DYSMENORRHEA: NO, PMS SYMPTOMS PELVIC PAIN. HX OF STDS: STATUS: YES, DIAGNOSIS CHLAMYDIA, GONORRHEA 07,09. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA FROM 2009 TO 2011. CONCURRENT CONDITIONS INCLUDED NON-SMOKER, ANXIETY, PAIN, INCISION SITE HYPOAESTHESIA, INCISION SITE HAEMATOMA, SUICIDAL IDEATION, DEPRESSION AND CHOLECYSTECTOMY. FAMILY HISTORY INCLUDED HEPATITIS. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) IN 2013 FOR BIRTH CONTROL AS WELL AS TERCONAZOLE. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED POLLAKIURIA ("BLADDER OR URINARY PROBLEMS OR CHANGES: FREQUENCY"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED LIBIDO DECREASED ("HORMONAL CHANGES - DECREASED LIBIDO"). IN 2014, THE PATIENT EXPERIENCED AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS"). IN 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL CRAMPS/ DYSMENORRHOEA(CRAMPING)"), MOOD SWINGS ("MOOD SWINGS"), IRRITABILITY ("IRRITABLE"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE:BLUR") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN,"). IN 2016, THE PATIENT EXPERIENCED ARTHRALGIA ("HIP PAIN, JOINT PAIN, KNEES PAIN"), GINGIVAL BLEEDING ("DENTAL PROBLEMS, BLEEDING GUMS") AND PAIN IN EXTREMITY ("LEG PAIN"). IN 2017, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES"), ALLERGY TO METALS ("NICKEL ALLERGY") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN/CRAMPING"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VAGINAL INFECTION ("VAGINAL INFECTION"), ABDOMINAL PAIN UPPER ("UPPER ABDOMINAL PAIN"), MENORRHAGIA ("SEVERE MENSTRUAL FLOW/ BLOOD LOSS"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), BACK PAIN ("CONSTANT LOWER BACK PAIN"), NERVE INJURY ("NERVES OF LEGS AFFECTED"), DEPRESSION ("DEPRESSION") AND SUICIDE ATTEMPT ("ATTEMPTED SUICIDE"). THE PATIENT WAS TREATED WITH ASCORBIC ACID;CALCIUM GLUCONATE;CUPRIC CARBONATE, BASIC;CYANOCOBALAMIN;ERGOCALCIFEROL;FERROUS SULFATE;MANGANESE CHLORIDE;NICOTINAMIDE;POTASSIUM IODIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE (PRENATAL) AND SURGERY (SURGICAL REMOVAL OF COIL). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ABDOMINAL PAIN, VAGINAL DISCHARGE, VAGINAL INFECTION, ABDOMINAL PAIN UPPER, MENORRHAGIA, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, BACK PAIN, ARTHRALGIA, NERVE INJURY, MOOD SWINGS, IRRITABILITY, POLLAKIURIA, MIGRAINE, GINGIVAL BLEEDING, AMNESIA, DYSPAREUNIA, VISION BLURRED, WEIGHT INCREASED, ALOPECIA, ALLERGY TO METALS, LIBIDO DECREASED, PAIN IN EXTREMITY, HEADACHE, DEPRESSION AND SUICIDE ATTEMPT OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALLERGY TO METALS, ALOPECIA, AMNESIA, ARTHRALGIA, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GINGIVAL BLEEDING, HEADACHE, IRRITABILITY, LIBIDO DECREASED, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NERVE INJURY, PAIN IN EXTREMITY, POLLAKIURIA, SUICIDE ATTEMPT, VAGINAL DISCHARGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2019, THE PATIENT WAS PREPPED AND DRAPED IN A NORMAL STERILE FASHION . BOTH ESSURE DEVICES WERE COMPLETELY REMOVED. BOTH TUBES WERE IMPLANTED IN THE CORNUAL ASPECT OF THE UTERUS AFTER FISH MOUTHING THE TUBES. AFTER COILS REMOVAL ON (B)(6) 2019, PLAINTIFF HAD INCOMPLETE MISCARRIAGE. DATE(S) OF INSERTION: (B)(6) 2013 (DISCREPANCY NOTED, AS PER PFS). DATE(S) OF REMOVAL: (B)(6) 2019 (DISCREPANCY). INSERTION DETAILS-TRAILING COILS: LEFT: 1 , RIGHT: 1 DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): CHOLECYSTECTOMY - IN 2004: NO RESULTS. LOT NUMBER REPORTED 802268 IS NOT VALID. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-SEP-2020: MEDICAL RECORD RECEIVED. LOT NUMBER ADDED. REPORTERS INFORMATION 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 RELEVANT 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 DEVICE DISLOCATION ('MIGRATION OF THE DEVICE') IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST: NO". THE PATIENT'S MEDICAL HISTORY INCLUDED MISCARRIAGE OF PREGNANCY IN (B)(6) 2019, CHOLECYSTECTOMY IN 2004, MULTI GRAVIDA, PARITY 4, EARLY MENARCHE, CHLAMYDIAL INFECTION, GONORRHEA, CHLAMYDIAL INFECTION, GONORRHEA, CHOLECYSTECTOMY IN 2004 AND LASER THERAPY (BIRTH MARK (NOSE)) IN 2002. NO KNOWN DRUG ALLERGY. SHE DOESNT DRINK ALCOHOL AND NO USE OF RECREATIONAL/STREET DRUGS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA FROM 2009 TO 2011. CONCURRENT CONDITIONS INCLUDED NON-SMOKER, ANXIETY, PAIN, INCISION SITE HYPOAESTHESIA, INCISION SITE HAEMATOMA, SUICIDAL IDEATION, DEPRESSION AND CHOLECYSTECTOMY. FAMILY HISTORY INCLUDED HEPATITIS. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) IN 2013 FOR BIRTH CONTROL AS WELL AS TERCONAZOLE. IN 2013, THE PATIENT EXPERIENCED POLLAKIURIA ("BLADDER OR URINARY PROBLEMS OR CHANGES: FREQUENCY"). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED LIBIDO DECREASED ("HORMONAL CHANGES - DECREASED LIBIDO"). IN 2014, THE PATIENT EXPERIENCED AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS"). IN 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL CRAMPS/ DYSMENORRHOEA(CRAMPING)"), MOOD SWINGS ("MOOD SWINGS"), IRRITABILITY ("IRRITABLE"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE:BLURR") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN,"). IN 2016, THE PATIENT EXPERIENCED ARTHRALGIA ("HIP PAIN, JOINT PAIN, KNEES PAIN"), GINGIVAL BLEEDING ("DENTAL PROBLEMS, BLEEDING GUMS") AND PAIN IN EXTREMITY ("LEG PAIN"). IN 2017, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES"), ALLERGY TO METALS ("NICKEL ALLERGY") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN/CRAMPING"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VAGINAL INFECTION ("VAGINAL INFECTION"), ABDOMINAL PAIN UPPER ("UPPER ABDOMINAL PAIN"), MENORRHAGIA ("SEVERE MENSTRUAL FLOW/ BLOOD LOSS"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), BACK PAIN ("CONSTANT LOWER BACK PAIN"), NERVE INJURY ("NERVES OF LEGS AFFECTED"), DEPRESSION ("DEPRESSION") AND SUICIDE ATTEMPT ("ATTEMPTED SUICIDE"). THE PATIENT WAS TREATED WITH ASCORBIC ACID;CALCIUM GLUCONATE;CUPRIC CARBONATE, BASIC;CYANOCOBALAMIN;ERGOCALCIFEROL;FERROUS SULFATE;MANGANESE CHLORIDE;NICOTINAMIDE;POTASSIUM IODIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE (PRENATAL) AND SURGERY (SURGICAL REMOVAL OF COIL). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ABDOMINAL PAIN, VAGINAL DISCHARGE, VAGINAL INFECTION, ABDOMINAL PAIN UPPER, MENORRHAGIA, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, BACK PAIN, ARTHRALGIA, NERVE INJURY, MOOD SWINGS, IRRITABILITY, POLLAKIURIA, MIGRAINE, GINGIVAL BLEEDING, AMNESIA, DYSPAREUNIA, VISION BLURRED, WEIGHT INCREASED, ALOPECIA, ALLERGY TO METALS, LIBIDO DECREASED, PAIN IN EXTREMITY, HEADACHE, DEPRESSION AND SUICIDE ATTEMPT OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALLERGY TO METALS, ALOPECIA, AMNESIA, ARTHRALGIA, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GINGIVAL BLEEDING, HEADACHE, IRRITABILITY, LIBIDO DECREASED, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NERVE INJURY, PAIN IN EXTREMITY, POLLAKIURIA, SUICIDE ATTEMPT, VAGINAL DISCHARGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2019, THE PATIENT WAS PREPPED AND DRAPED IN A NORMAL STERILE FASHION . BOTH ESSURE DEVICES WERE COMPLETELY REMOVED. BOTH TUBES WERE IMPLANTED IN THE CORNUAL ASPECT OF THE UTERUS AFTER FISH MOUTHING THE TUBES. AFTER COILS REMOVAL ON (B)(6) 2019, PLAINTIFF HAD INCOMPLETE MISCARRIAGE. DATE(S) OF INSERTION: (B)(6) 2013 (DISCREPANCY NOTED, AS PER PFS). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): CHOLECYSTECTOMY - IN 2004: . DIAGNOSTIC RESULTS: (B)(6) 2013 - MENARCHE: BEGAN AT AGE: 10. MENSTRUATION: INTERVALS: REGULAR/MONTHLY, DURATION: 7 DAYS, CHARACTER OF PERIOD: NORMAL, DYSMENORRHEA: NO, PMS SYMPTOMS PELVIC PAIN. HX OF STDS: STATUS: YES, DIAGNOSIS CHLAMYDIA, GONORRHEA 07,09. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-APR-2020: PFS RECEIVED: EVENTS: DEPRESSION AND ATTEMPTED SUICIDE WERE ADDED. ON 21-APR-2020: MR RECEIVED: REPORTER WAS ADDED. FU 9 AND 10 PROCESSED TOGETHER. 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 DEVICE DISLOCATION ('MIGRATION OF THE DEVICE') IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802268) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST: NO". THE PATIENT'S MEDICAL HISTORY INCLUDED MISCARRIAGE OF PREGNANCY IN (B)(6) 2019, CHOLECYSTECTOMY IN 2004, MULTI GRAVIDA, PARITY 4, EARLY MENARCHE, CHLAMYDIAL INFECTION, GONORRHEA, CHLAMYDIAL INFECTION, GONORRHEA, CHOLECYSTECTOMY IN 2004 AND LASER THERAPY (BIRTH MARK (NOSE)) IN 2002. NO KNOWN DRUG ALLERGY. SHE DOESNT DRINK ALCOHOL AND NO USE OF RECREATIONAL/STREET DRUGS. (B)(6) 2013 - MENARCHE: BEGAN AT AGE: 10. MENSTRUATION: INTERVALS: REGULAR/MONTHLY, DURATION: 7 DAYS, CHARACTER OF PERIOD: NORMAL, DYSMENORRHEA: NO, PMS SYMPTOMS PELVIC PAIN. HX OF STDS: STATUS: YES, DIAGNOSIS CHLAMYDIA, GONORRHEA 07,09. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA FROM 2009 TO 2011. CONCURRENT CONDITIONS INCLUDED NON-SMOKER, ANXIETY, PAIN, INCISION SITE HYPOAESTHESIA, INCISION SITE HAEMATOMA, SUICIDAL IDEATION, DEPRESSION AND CHOLECYSTECTOMY. FAMILY HISTORY INCLUDED HEPATITIS. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) IN 2013 FOR BIRTH CONTROL AS WELL AS TERCONAZOLE. IN 2013, THE PATIENT EXPERIENCED POLLAKIURIA ("BLADDER OR URINARY PROBLEMS OR CHANGES: FREQUENCY"). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED LIBIDO DECREASED ("HORMONAL CHANGES - DECREASED LIBIDO"). IN 2014, THE PATIENT EXPERIENCED AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS"). IN 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL CRAMPS/ DYSMENORRHOEA(CRAMPING)"), MOOD SWINGS ("MOOD SWINGS"), IRRITABILITY ("IRRITABLE"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE:BLURR") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN,"). IN 2016, THE PATIENT EXPERIENCED ARTHRALGIA ("HIP PAIN, JOINT PAIN, KNEES PAIN"), GINGIVAL BLEEDING ("DENTAL PROBLEMS, BLEEDING GUMS") AND PAIN IN EXTREMITY ("LEG PAIN"). IN 2017, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES"), ALLERGY TO METALS ("NICKEL ALLERGY") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN/CRAMPING"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VAGINAL INFECTION ("VAGINAL INFECTION"), ABDOMINAL PAIN UPPER ("UPPER ABDOMINAL PAIN"), MENORRHAGIA ("SEVERE MENSTRUAL FLOW/ BLOOD LOSS"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), BACK PAIN ("CONSTANT LOWER BACK PAIN"), NERVE INJURY ("NERVES OF LEGS AFFECTED"), DEPRESSION ("DEPRESSION") AND SUICIDE ATTEMPT ("ATTEMPTED SUICIDE"). THE PATIENT WAS TREATED WITH ASCORBIC ACID;CALCIUM GLUCONATE;CUPRIC CARBONATE, BASIC;CYANOCOBALAMIN;ERGOCALCIFEROL;FERROUS SULFATE;MANGANESE CHLORIDE;NICOTINAMIDE;POTASSIUM IODIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE (PRENATAL) AND SURGERY (SURGICAL REMOVAL OF COIL). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ABDOMINAL PAIN, VAGINAL DISCHARGE, VAGINAL INFECTION, ABDOMINAL PAIN UPPER, MENORRHAGIA, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, BACK PAIN, ARTHRALGIA, NERVE INJURY, MOOD SWINGS, IRRITABILITY, POLLAKIURIA, MIGRAINE, GINGIVAL BLEEDING, AMNESIA, DYSPAREUNIA, VISION BLURRED, WEIGHT INCREASED, ALOPECIA, ALLERGY TO METALS, LIBIDO DECREASED, PAIN IN EXTREMITY, HEADACHE, DEPRESSION AND SUICIDE ATTEMPT OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALLERGY TO METALS, ALOPECIA, AMNESIA, ARTHRALGIA, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GINGIVAL BLEEDING, HEADACHE, IRRITABILITY, LIBIDO DECREASED, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NERVE INJURY, PAIN IN EXTREMITY, POLLAKIURIA, SUICIDE ATTEMPT, VAGINAL DISCHARGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2019, THE PATIENT WAS PREPPED AND DRAPED IN A NORMAL STERILE FASHION . BOTH ESSURE DEVICES WERE COMPLETELY REMOVED. BOTH TUBES WERE IMPLANTED IN THE CORNUAL ASPECT OF THE UTERUS AFTER FISH MOUTHING THE TUBES. AFTER COILS REMOVAL ON (B)(6) 2019, PLAINTIFF HAD INCOMPLETE MISCARRIAGE. DATE(S) OF INSERTION: (B)(6) 2013 (DISCREPANCY NOTED, AS PER PFS). INSERTION DETAILS-TRAILING COILS: LEFT: 1 , RIGHT: 1. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): CHOLECYSTECTOMY - IN 2004. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-MAY-2020: PFS RECEIVED: LOT NUMBER 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 RELEVANT 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 DEVICE DISLOCATION ('MIGRATION OF THE DEVICE') IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802268-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST: NO". THE PATIENT'S MEDICAL HISTORY INCLUDED MISCARRIAGE OF PREGNANCY IN DECEMBER 2019, CHOLECYSTECTOMY IN 2004, MULTI GRAVIDA, PARITY 4, EARLY MENARCHE, CHLAMYDIAL INFECTION, GONORRHEA, CHLAMYDIAL INFECTION, GONORRHEA, CHOLECYSTECTOMY IN 2004 AND LASER THERAPY (BIRTH MARK (NOSE)) IN 2002. NO KNOWN DRUG ALLERGY. SHE DOESNT DRINK ALCOHOL AND NO USE OF RECREATIONAL/STREET DRUGS. *(B)(6) 2013 - MENARCHE: BEGAN AT AGE: 10. MENSTRUATION: INTERVALS: REGULAR/MONTHLY, DURATION: 7 DAYS, CHARACTER OF PERIOD: NORMAL, DYSMENORRHEA: NO, PMS SYMPTOMS PELVIC PAIN. HX OF STDS: STATUS: YES, DIAGNOSIS CHLAMYDIA, GONORRHEA 07,09. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA FROM 2009 TO 2011. CONCURRENT CONDITIONS INCLUDED NON-SMOKER, ANXIETY, PAIN, INCISION SITE HYPOAESTHESIA, INCISION SITE HAEMATOMA, SUICIDAL IDEATION, DEPRESSION AND CHOLECYSTECTOMY. FAMILY HISTORY INCLUDED HEPATITIS. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) IN 2013 FOR BIRTH CONTROL AS WELL AS TERCONAZOLE. IN 2013, THE PATIENT EXPERIENCED POLLAKIURIA ("BLADDER OR URINARY PROBLEMS OR CHANGES: FREQUENCY"). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED LIBIDO DECREASED ("HORMONAL CHANGES - DECREASED LIBIDO"). IN 2014, THE PATIENT EXPERIENCED AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS"). IN 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL CRAMPS/ DYSMENORRHOEA(CRAMPING)"), MOOD SWINGS ("MOOD SWINGS"), IRRITABILITY ("IRRITABLE"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE:BLURR") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN,"). IN 2016, THE PATIENT EXPERIENCED ARTHRALGIA ("HIP PAIN, JOINT PAIN, KNEES PAIN"), GINGIVAL BLEEDING ("DENTAL PROBLEMS, BLEEDING GUMS") AND PAIN IN EXTREMITY ("LEG PAIN"). IN 2017, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES"), ALLERGY TO METALS ("NICKEL ALLERGY") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN/CRAMPING"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VAGINAL INFECTION ("VAGINAL INFECTION"), ABDOMINAL PAIN UPPER ("UPPER ABDOMINAL PAIN"), MENORRHAGIA ("SEVERE MENSTRUAL FLOW/ BLOOD LOSS"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), BACK PAIN ("CONSTANT LOWER BACK PAIN"), NERVE INJURY ("NERVES OF LEGS AFFECTED"), DEPRESSION ("DEPRESSION") AND SUICIDE ATTEMPT ("ATTEMPTED SUICIDE"). THE PATIENT WAS TREATED WITH ASCORBIC ACID;CALCIUM GLUCONATE;CUPRIC CARBONATE, BASIC;CYANOCOBALAMIN;ERGOCALCIFEROL;FERROUS SULFATE;MANGANESE CHLORIDE;NICOTINAMIDE;POTASSIUM IODIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE (PRENATAL) AND SURGERY (SURGICAL REMOVAL OF COIL). ESSURE WAS REMOVED ON (B)(6) -2019. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ABDOMINAL PAIN, VAGINAL DISCHARGE, VAGINAL INFECTION, ABDOMINAL PAIN UPPER, MENORRHAGIA, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, BACK PAIN, ARTHRALGIA, NERVE INJURY, MOOD SWINGS, IRRITABILITY, POLLAKIURIA, MIGRAINE, GINGIVAL BLEEDING, AMNESIA, DYSPAREUNIA, VISION BLURRED, WEIGHT INCREASED, ALOPECIA, ALLERGY TO METALS, LIBIDO DECREASED, PAIN IN EXTREMITY, HEADACHE, DEPRESSION AND SUICIDE ATTEMPT OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALLERGY TO METALS, ALOPECIA, AMNESIA, ARTHRALGIA, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GINGIVAL BLEEDING, HEADACHE, IRRITABILITY, LIBIDO DECREASED, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NERVE INJURY, PAIN IN EXTREMITY, POLLAKIURIA, SUICIDE ATTEMPT, VAGINAL DISCHARGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2019, THE PATIENT WAS PREPPED AND DRAPED IN A NORMAL STERILE FASHION . BOTH ESSURE DEVICES WERE COMPLETELY REMOVED. BOTH TUBES WERE IMPLANTED IN THE CORNUAL ASPECT OF THE UTERUS AFTER FISH MOUTHING THE TUBES. AFTER COILS REMOVAL ON (B)(6) 2019, PLAINTIFF HAD INCOMPLETE MISCARRIAGE. DATE(S) OF INSERTION: (B)(6) 2013 (DISCREPANCY NOTED, AS PER PFS). INSERTION DETAILS-TRAILING COILS: LEFT: 1 , RIGHT: 1. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): CHOLECYSTECTOMY - IN 2004: . LOT NUMBER REPORTED 802268 IS NOT VALID. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-JUN-2020: UPDATE OF INFORMATION (BATCH IS NOT VALID). 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 DEVICE DISLOCATION ('MIGRATION OF THE DEVICE') IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST: NO". THE PATIENT'S MEDICAL HISTORY INCLUDED MISCARRIAGE OF PREGNANCY IN (B)(6) 2019, CHOLECYSTECTOMY IN 2004, MULTI GRAVIDA, PARITY 4, EARLY MENARCHE, CHLAMYDIAL INFECTION, GONORRHEA, CHLAMYDIAL INFECTION, GONORRHEA, CHOLECYSTECTOMY IN 2004 AND LASER THERAPY (BIRTH MARK (NOSE)) IN 2002. NO KNOWN DRUG ALLERGY. SHE DOESNT DRINK ALCOHOL AND NO USE OF RECREATIONAL/STREET DRUGS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA FROM 2009 TO 2011. CONCURRENT CONDITIONS INCLUDED NON-SMOKER, ANXIETY, PAIN, INCISION SITE HYPOAESTHESIA, INCISION SITE HAEMATOMA, SUICIDAL IDEATION, DEPRESSION AND CHOLECYSTECTOMY. FAMILY HISTORY INCLUDED HEPATITIS. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) IN 2013 FOR BIRTH CONTROL AS WELL AS TERCONAZOLE. IN 2013, THE PATIENT EXPERIENCED POLLAKIURIA ("BLADDER OR URINARY PROBLEMS OR CHANGES: FREQUENCY"). ON(B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED LIBIDO DECREASED ("HORMONAL CHANGES - DECREASED LIBIDO"). IN 2014, THE PATIENT EXPERIENCED AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS"). IN 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL CRAMPS/ DYSMENORRHOEA(CRAMPING)"), MOOD SWINGS ("MOOD SWINGS"), IRRITABILITY ("IRRITABLE"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE:BLURR") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN,"). IN 2016, THE PATIENT EXPERIENCED ARTHRALGIA ("HIP PAIN, JOINT PAIN, KNEES PAIN"), GINGIVAL BLEEDING ("DENTAL PROBLEMS, BLEEDING GUMS") AND PAIN IN EXTREMITY ("LEG PAIN"). IN 2017, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES"), ALLERGY TO METALS ("NICKEL ALLERGY") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN/CRAMPING"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VAGINAL INFECTION ("VAGINAL INFECTION"), ABDOMINAL PAIN UPPER ("UPPER ABDOMINAL PAIN"), MENORRHAGIA ("SEVERE MENSTRUAL FLOW/ BLOOD LOSS"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), BACK PAIN ("CONSTANT LOWER BACK PAIN"), NERVE INJURY ("NERVES OF LEGS AFFECTED"), DEPRESSION ("DEPRESSION") AND SUICIDE ATTEMPT ("ATTEMPTED SUICIDE"). THE PATIENT WAS TREATED WITH ASCORBIC ACID;CALCIUM GLUCONATE;CUPRIC CARBONATE, BASIC;CYANOCOBALAMIN;ERGOCALCIFEROL;FERROUS SULFATE;MANGANESE CHLORIDE;NICOTINAMIDE;POTASSIUM IODIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE (PRENATAL) AND SURGERY (SURGICAL REMOVAL OF COIL). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ABDOMINAL PAIN, VAGINAL DISCHARGE, VAGINAL INFECTION, ABDOMINAL PAIN UPPER, MENORRHAGIA, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, BACK PAIN, ARTHRALGIA, NERVE INJURY, MOOD SWINGS, IRRITABILITY, POLLAKIURIA, MIGRAINE, GINGIVAL BLEEDING, AMNESIA, DYSPAREUNIA, VISION BLURRED, WEIGHT INCREASED, ALOPECIA, ALLERGY TO METALS, LIBIDO DECREASED, PAIN IN EXTREMITY, HEADACHE, DEPRESSION AND SUICIDE ATTEMPT OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALLERGY TO METALS, ALOPECIA, AMNESIA, ARTHRALGIA, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GINGIVAL BLEEDING, HEADACHE, IRRITABILITY, LIBIDO DECREASED, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NERVE INJURY, PAIN IN EXTREMITY, POLLAKIURIA, SUICIDE ATTEMPT, VAGINAL DISCHARGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2019, THE PATIENT WAS PREPPED AND DRAPED IN A NORMAL STERILE FASHION . BOTH ESSURE DEVICES WERE COMPLETELY REMOVED. BOTH TUBES WERE IMPLANTED IN THE CORNUAL ASPECT OF THE UTERUS AFTER FISH MOUTHING THE TUBES. AFTER COILS REMOVAL ON (B)(6) 2019, PLAINTIFF HAD INCOMPLETE MISCARRIAGE. DATE(S) OF INSERTION: (B)(6) 2013 (DISCREPANCY NOTED, AS PER PFS). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): CHOLECYSTECTOMY - IN 2004: . DIAGNOSTIC RESULTS: (B)(6) 2013 - MENARCHE: BEGAN AT AGE: 10. MENSTRUATION: INTERVALS: REGULAR/MONTHLY, DURATION: 7 DAYS, CHARACTER OF PERIOD: NORMAL, DYSMENORRHEA: NO, PMS SYMPTOMS PELVIC PAIN. HX OF STDS: STATUS: YES, DIAGNOSIS CHLAMYDIA, GONORRHEA 07,09. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: QUALITY SAFETY EVALUATION OF PTC. 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 DEVICE DISLOCATION ("MIGRATION OF THE DEVICE") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST: NO". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA, PARITY 4, EARLY MENARCHE, CHLAMYDIAL INFECTION, GONORRHEA, CHOLECYSTECTOMY IN 2004, CHLAMYDIAL INFECTION, GONORRHEA, CHOLECYSTECTOMY IN 2004 AND LASER THERAPY (BIRTH MARK (NOSE)) IN 2002. NO KNOWN DRUG ALLERGY. SHE DOESNT DRINK ALCOHOL AND NO USE OF RECREATIONAL/STREET DRUGS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA FROM 2009 TO 2011. CONCURRENT CONDITIONS INCLUDED NON-SMOKER. FAMILY HISTORY INCLUDED HEPATITIS. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) IN 2013 FOR BIRTH CONTROL. IN 2013, THE PATIENT EXPERIENCED POLLAKIURIA ("BLADDER OR URINARY PROBLEMS OR CHANGES: FREQUENCY"). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED LIBIDO DECREASED ("HORMONAL CHANGES - DECREASED LIBIDO"). IN 2014, THE PATIENT EXPERIENCED AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS"). IN 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL CRAMPS/DYSMENORRHOEA(CRAMPING)"), MOOD SWINGS ("MOOD SWINGS"), IRRITABILITY ("IRRITABLE"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE:BLURR"), WEIGHT INCREASED ("WEIGHT GAIN/LOSS SPECIFY WHICH ONE: WEIGHT GAIN,") AND ALOPECIA ("HAIR LOSS"). IN 2016, THE PATIENT EXPERIENCED ARTHRALGIA ("HIP PAIN, JOINT PAIN, KNEES PAIN"), GINGIVAL BLEEDING ("DENTAL PROBLEMS, BLEEDING GUMS") AND PAIN IN EXTREMITY ("LEG PAIN"). IN 2017, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES"), ALLERGY TO METALS ("NICKEL ALLERGY") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN/CRAMPING"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VAGINAL INFECTION ("VAGINAL INFECTION"), ABDOMINAL PAIN UPPER ("UPPER ABDOMINAL PAIN"), MENORRHAGIA ("SEVERE MENSTRUAL FLOW"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), BACK PAIN ("CONSTANT LOWER BACK PAIN") AND NERVE INJURY ("NERVES OF LEGS AFFECTED"). THE PATIENT WAS TREATED WITH PRENATAL. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ABDOMINAL PAIN, VAGINAL DISCHARGE, VAGINAL INFECTION, ABDOMINAL PAIN UPPER, MENORRHAGIA, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, BACK PAIN, ARTHRALGIA, NERVE INJURY, MOOD SWINGS, IRRITABILITY, POLLAKIURIA, MIGRAINE, GINGIVAL BLEEDING, AMNESIA, DYSPAREUNIA, VISION BLURRED, WEIGHT INCREASED, ALOPECIA, ALLERGY TO METALS, LIBIDO DECREASED, PAIN IN EXTREMITY AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALLERGY TO METALS, ALOPECIA, AMNESIA, ARTHRALGIA, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GINGIVAL BLEEDING, HEADACHE, IRRITABILITY, LIBIDO DECREASED, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NERVE INJURY, PAIN IN EXTREMITY, POLLAKIURIA, VAGINAL DISCHARGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. ON (B)(6) 2013 - MENARCHE: BEGAN AT AGE: (B)(6). MENSTRUATION: INTERVALS: REGULAR/MONTHLY, DURATION: 7 DAYS, CHARACTER OF PERIOD: NORMAL, DYSMENORRHEA: NO, PMS SYMPTOMS PELVIC PAIN. HX OF STDS: STATUS: YES, DIAGNOSIS CHLAMYDIA, GONORRHEA 07,09. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-OCT-2018: PLAINTIFF FACT SHEET RECEIVED. EVENT LEG PAIN AND HEADACHE WAS ADDED. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 836908 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 802268-INV, B02269 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Other| R | 1) DEPO PROVERA (MEDROXYPROGESTERONE)| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| TERCONAZOLE| TERCONAZOLE| TERCONAZOLE| TERCONAZOLE| TERCONAZOLE| TERCONAZOLE| DEPO PROVERA (MEDROXYPROGESTERONE) |