ESSURE
Report
- Report Number
- 2951250-2017-01585
- Event Type
- Injury
- Date Received
- April 20, 2017
- Date of Event
- January 1, 2011
- Report Date
- January 7, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING / ABNORMAL BLEEDING (GENERAL)") AND MULTIPLE SCLEROSIS ("MULTIPLE SCLEROSIS") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 844600) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MISSED ABORTION ON (B)(6) 2010, NEPHROLITHIASIS AND TONSILLECTOMY. CONCURRENT CONDITIONS INCLUDED MUSCLE SPASM. CONCOMITANT PRODUCTS INCLUDED BACLOFEN, FINGOLIMOD HYDROCHLORIDE (GILENYA), OMEPRAZOLE SINCE 2013, PRENATAL VITAMINS FROM 2014 TO 2017 AND VENLAFAXINE. IN 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MULTIPLE SCLEROSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MORPHOEA ("SCLEROSIS"), HEADACHE ("HEADACHES"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), SWELLING ("SWELLING"), ARTHRALGIA ("JOINT PAIN"), RASH ("SKIN RASH"), INFECTION ("INFECTION"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), MIGRAINE ("MIGRAINES"), TOOTH DISORDER ("DENTAL PROBLEMS"), NAUSEA ("NAUSEA"), NERVOUS SYSTEM DISORDER ("NEUROLOGICAL CONDITIONS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), WEIGHT INCREASED ("WEIGHT GAIN"), URINARY TRACT INFECTION ("FREQUENT UTIS."), HYPERSENSITIVITY ("HYPERSENSITIVITY REACTION"), DYSURIA ("DYSURIA"), ABDOMINAL PAIN LOWER ("LEFT LOWER QUADRANT PAIN"), FOLLICULITIS ("BACTERIAL FOLLICULITIS"), ACNE ("ADULT ACNE"), MEMORY IMPAIRMENT ("MEMORY PROBLEMS / DIFFICULTY REMEMBERING THINGS"), ALLERGY TO METALS ("NICKEL ALLERGY"), AMNESIA ("MEMORY LOSS"), GINGIVAL BLEEDING ("BLEEDING GUMS") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MULTIPLE SCLEROSIS, MORPHOEA, HEADACHE, DEPRESSION, FATIGUE, ALOPECIA, SWELLING, ARTHRALGIA, RASH, VAGINAL HAEMORRHAGE, MENORRHAGIA, INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, TOOTH DISORDER, NAUSEA, NERVOUS SYSTEM DISORDER, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, WEIGHT INCREASED, URINARY TRACT INFECTION, HYPERSENSITIVITY, DYSURIA, ABDOMINAL PAIN LOWER, ANXIETY, FOLLICULITIS, ACNE, MEMORY IMPAIRMENT, ALLERGY TO METALS, AMNESIA, GINGIVAL BLEEDING AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ACNE, ALLERGY TO METALS, ALOPECIA, AMNESIA, ANXIETY, ARTHRALGIA, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, FATIGUE, FOLLICULITIS, GENITAL HAEMORRHAGE, GINGIVAL BLEEDING, HEADACHE, HYPERSENSITIVITY, INFECTION, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, MORPHOEA, MULTIPLE SCLEROSIS, NAUSEA, NERVOUS SYSTEM DISORDER, PELVIC PAIN, RASH, SWELLING, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 155 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT: HEADACHES AND MULTIPLE SCLEROSIS, URINARY TRACT INFECTION,MENORRHAGIA,PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-JUN-2018: PFS+MR RECEIVED, REPORTER ADDED, CONCOMITANT DRUG ADDED EVENT ADDED AS : ANXIETY, BACTERIAL "FOLLICULITIS", ACNE, MULTIPLE SCLEROSIS, MEMORY IMPAIRMENT, ALLERGY TO METAL, AMNESIA, GINGIVAL BLEEDING, ABDOMINAL PAIN. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING / ABNORMAL BLEEDING (GENERAL)") AND MULTIPLE SCLEROSIS ("MULTIPLE SCLEROSIS") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 844600) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MISSED ABORTION ON 10-AUG-2010, NEPHROLITHIASIS AND TONSILLECTOMY. CONCURRENT CONDITIONS INCLUDED MUSCLE SPASM. CONCOMITANT PRODUCTS INCLUDED BACLOFEN, FINGOLIMOD HYDROCHLORIDE (GILENYA), OMEPRAZOLE SINCE 2013, PRENATAL VITAMINS FROM 2014 TO 2017 AND VENLAFAXINE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). IN 2014, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MULTIPLE SCLEROSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MORPHOEA ("SCLEROSIS"), HEADACHE ("HEADACHES"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), SWELLING ("SWELLING"), ARTHRALGIA ("JOINT PAIN"), RASH ("SKIN RASH"), INFECTION ("INFECTION"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), MIGRAINE ("MIGRAINES"), TOOTH DISORDER ("DENTAL PROBLEMS"), NAUSEA ("NAUSEA"), NERVOUS SYSTEM DISORDER ("NEUROLOGICAL CONDITIONS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), WEIGHT INCREASED ("WEIGHT GAIN"), URINARY TRACT INFECTION ("FREQUENT UTIS."), HYPERSENSITIVITY ("HYPERSENSITIVITY REACTION"), DYSURIA ("DYSURIA"), ABDOMINAL PAIN LOWER ("LEFT LOWER QUADRANT PAIN"), FOLLICULITIS ("BACTERIAL FOLLICULITIS"), ACNE ("ADULT ACNE"), MEMORY IMPAIRMENT ("MEMORY PROBLEMS / DIFFICULTY REMEMBERING THINGS"), ALLERGY TO METALS ("NICKEL ALLERGY"), AMNESIA ("MEMORY LOSS"), GINGIVAL BLEEDING ("BLEEDING GUMS") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MULTIPLE SCLEROSIS, MORPHOEA, HEADACHE, DEPRESSION, FATIGUE, ALOPECIA, SWELLING, ARTHRALGIA, RASH, VAGINAL HAEMORRHAGE, MENORRHAGIA, INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, TOOTH DISORDER, NAUSEA, NERVOUS SYSTEM DISORDER, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, WEIGHT INCREASED, URINARY TRACT INFECTION, HYPERSENSITIVITY, DYSURIA, ABDOMINAL PAIN LOWER, ANXIETY, FOLLICULITIS, ACNE, MEMORY IMPAIRMENT, ALLERGY TO METALS, AMNESIA, GINGIVAL BLEEDING AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ACNE, ALLERGY TO METALS, ALOPECIA, AMNESIA, ANXIETY, ARTHRALGIA, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, FATIGUE, FOLLICULITIS, GENITAL HAEMORRHAGE, GINGIVAL BLEEDING, HEADACHE, HYPERSENSITIVITY, INFECTION, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, MORPHOEA, MULTIPLE SCLEROSIS, NAUSEA, NERVOUS SYSTEM DISORDER, PELVIC PAIN, RASH, SWELLING, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 155 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON 28-NOV-2011: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT: HEADACHES AND MULTIPLE SCLEROSIS, URINARY TRACT INFECTION,MENORRHAGIA,PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-AUG-2018: QUALITY-SAFETY EVALUATION OF PTC. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING / ABNORMAL BLEEDING (GENERAL)") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 844600) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MORPHOEA ("SCLEROSIS"), HEADACHE ("HEADACHES"), DEPRESSION ("DEPRESSION"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), SWELLING ("SWELLING"), ARTHRALGIA ("JOINT PAIN"), RASH ("SKIN RASH"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), INFECTION ("INFECTION"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), MIGRAINE ("MIGRAINES"), TOOTH DISORDER ("DENTAL PROBLEMS"), NAUSEA ("NAUSEA"), NERVOUS SYSTEM DISORDER ("NEUROLOGICAL CONDITIONS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), WEIGHT INCREASED ("WEIGHT GAIN"), URINARY TRACT INFECTION ("FREQUENT UTIS."), HYPERSENSITIVITY ("HYPERSENSITIVITY REACTION"), DYSURIA ("DYSURIA") AND ABDOMINAL PAIN LOWER ("LEFT LOWER QUADRANT PAIN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MORPHOEA, HEADACHE, DEPRESSION, FATIGUE, ALOPECIA, SWELLING, ARTHRALGIA, RASH, VAGINAL HAEMORRHAGE, MENORRHAGIA, INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, TOOTH DISORDER, NAUSEA, NERVOUS SYSTEM DISORDER, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, WEIGHT INCREASED, URINARY TRACT INFECTION, HYPERSENSITIVITY, DYSURIA AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ARTHRALGIA, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, INFECTION, MENORRHAGIA, MIGRAINE, MORPHOEA, NAUSEA, NERVOUS SYSTEM DISORDER, PELVIC PAIN, RASH, SWELLING, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 155 LBS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: EVENTS- "ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), INFECTION, BLADDER PROBLEMS, URINARY PROBLEMS, MIGRAINES, DENTAL PROBLEMS, NAUSEA, NEUROLOGICAL CONDITIONS, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), VAGINAL DISCHARGE, WEIGHT GAIN, FREQUENT UTIS, HYPERSENSITIVITY REACTION, LEFT LOWER QUADRANT PAIN, DYSURIA", LOT NUMBER, REPORTER ADDED FROM PFS. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING / ABNORMAL BLEEDING (GENERAL)") AND MULTIPLE SCLEROSIS ("MULTIPLE SCLEROSIS") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 844600) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MISSED ABORTION ON (B)(6) 2010, NEPHROLITHIASIS, TONSILLECTOMY, IRREGULAR PERIODS, GASTRIC DISORDER AND DIGESTION IMPAIRED. CONCURRENT CONDITIONS INCLUDED MUSCLE SPASM. CONCOMITANT PRODUCTS INCLUDED BACLOFEN, FINGOLIMOD HYDROCHLORIDE (GILENYA), OMEPRAZOLE SINCE 2013, PRENATAL VITAMINS FROM 2014 TO 2017 AND VENLAFAXINE. IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN 2014, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MULTIPLE SCLEROSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MORPHOEA ("SCLEROSIS"), HEADACHE ("HEADACHES"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), SWELLING ("SWELLING"), ARTHRALGIA ("JOINT PAIN"), RASH ("SKIN RASH/RASHES OR SKIN CONDITIONS - TYPE:"), INFECTION ("INFECTION"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), MIGRAINE ("MIGRAINES"), TOOTH DISORDER ("DENTAL PROBLEMS"), NAUSEA ("NAUSEA"), NERVOUS SYSTEM DISORDER ("NEUROLOGICAL CONDITIONS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), WEIGHT INCREASED ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) WEIGHT GAIN"), URINARY TRACT INFECTION ("FREQUENT UTIS/INFECTION (BLADDER/URINARY TRACT/VAGINAL) - TYPE:"), HYPERSENSITIVITY ("HYPERSENSITIVITY REACTION"), DYSURIA ("DYSURIA"), ABDOMINAL PAIN LOWER ("LEFT LOWER QUADRANT PAIN"), FOLLICULITIS ("BACTERIAL FOLLICULITIS"), ACNE ("ADULT ACNE"), MEMORY IMPAIRMENT ("MEMORY PROBLEMS / DIFFICULTY REMEMBERING THINGS"), ALLERGY TO METALS ("NICKEL ALLERGY"), AMNESIA ("MEMORY LOSS"), GINGIVAL BLEEDING ("DENTAL PROBLEMS BLEEDING GUMS"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSPEPSIA ("DIGESTION ISSUES BECAME MUCH WORSE AFTER ESSURE PLACEMENT"), GASTRIC DISORDER ("STOMACH ISSUES BECAME MUCH WORSE AFTER ESSURE PLACEMENT") AND MENSTRUATION IRREGULAR ("PERIODS DATES BECAME EVEN MORE IRREGULAR AFTER ESSURE PLACEMENT"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MULTIPLE SCLEROSIS, MORPHOEA, HEADACHE, DEPRESSION, FATIGUE, ALOPECIA, SWELLING, ARTHRALGIA, RASH, VAGINAL HAEMORRHAGE, MENORRHAGIA, INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, TOOTH DISORDER, NAUSEA, NERVOUS SYSTEM DISORDER, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, WEIGHT INCREASED, URINARY TRACT INFECTION, HYPERSENSITIVITY, DYSURIA, ABDOMINAL PAIN LOWER, ANXIETY, FOLLICULITIS, ACNE, MEMORY IMPAIRMENT, ALLERGY TO METALS, AMNESIA, GINGIVAL BLEEDING, ABDOMINAL PAIN AND MENSTRUATION IRREGULAR OUTCOME WAS UNKNOWN AND THE DYSPEPSIA AND GASTRIC DISORDER HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ACNE, ALLERGY TO METALS, ALOPECIA, AMNESIA, ANXIETY, ARTHRALGIA, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, DYSURIA, FATIGUE, FOLLICULITIS, GASTRIC DISORDER, GENITAL HAEMORRHAGE, GINGIVAL BLEEDING, HEADACHE, HYPERSENSITIVITY, INFECTION, MEMORY IMPAIRMENT, MENORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, MORPHOEA, MULTIPLE SCLEROSIS, NAUSEA, NERVOUS SYSTEM DISORDER, PELVIC PAIN, RASH, SWELLING, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 155 LBS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT: HEADACHES AND MULTIPLE SCLEROSIS, URINARY TRACT INFECTION,MENORRHAGIA,PELVIC PAIN QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET RECEIVED, EVENT ONSET DATES ADDED, HISTORICAL CONDITIONS ADDED. EVENTS STOMACH/GASTRIC ISSUES BECAME MUCH WORSE AFTER ESSURE PLACEMENT AND PERIODS DATES BECAME EVEN MORE IRREGULAR AFTER ESSURE PLACEMENT WERE ADDED. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 844600) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CONGESTIVE CARDIOMYOPATHY IN 2015, IRRITABLE BOWEL SYNDROME IN 2015, PULMONARY HYPERTENSION IN 2015, DIZZINESS IN 2013, MISSED ABORTION ON (B)(6) 2010, GERD IN 1990, NEPHROLITHIASIS, TONSILLECTOMY, IRREGULAR PERIODS, GASTRIC DISORDER, DIGESTION IMPAIRED AND STOMACH PAIN. CONCURRENT CONDITIONS INCLUDED MUSCLE SPASM, EXHAUSTION, STRESS, CRAWLING SENSATION OF SKIN, GASTROINTESTINAL PAIN, ENERGY DECREASED, OVERWEIGHT, ACNE VULGARIS, HEARING LOSS BILATERAL, MUSCULOSKELETAL PAIN, HERPES SIMPLEX, DERMATITIS AND VAGINAL LESION. CONCOMITANT PRODUCTS INCLUDED BACLOFEN, FINGOLIMOD HYDROCHLORIDE (GILENYA), GABAPENTIN (GABAPENTINE) SINCE 2016, MINERALS NOS; VITAMINS NOS (PRENATAL VITAMINS) FROM 2014 TO 2017, OMEPRAZOLE SINCE 2013, TRAMADOL SINCE 2016 AND VENLAFAXINE. IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FATIGUE ("FATIGUE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA"), STAPHYLOCOCCAL INFECTION ("INFECTION (OTHER) DESCRIBE: MRSA"), MIGRAINE ("MIGRAINES/ HEADACHES"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE") AND GASTRIC DISORDER ("STOMACH ISSUES BECAME MUCH WORSE AFTER ESSURE PLACEMENT/ GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: STOMACH/DIGESTION ISSUES"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS-CONDITION: DEPRESSION"), RASH ("SKIN RASH/RASHES OR SKIN CONDITIONS - TYPE:"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEM OR CONDITION: ANXIETY"). IN 2013, THE PATIENT EXPERIENCED MULTIPLE SCLEROSIS ("AUTOIMMUNE DISORDER TYPE OF DISORDER: MULTIPLE SCLEROSIS") AND AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS-TYPE: MEMORY LOSS"). IN 2014, THE PATIENT EXPERIENCED CYSTITIS ("FREQUENT UTIS/INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE:") AND VAGINAL INFECTION ("FREQUENT UTIS/INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE"). IN 2015, THE PATIENT EXPERIENCED GINGIVAL BLEEDING ("DENTAL PROBLEMS BLEEDING GUMS"). IN 2016, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) WEIGHT GAIN"). ON (B)(6) 2016, THE PATIENT WAS FOUND TO HAVE BIOPSY ENDOMETRIUM ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: ENDOMETRIAL BIOPSY"), 4 YEARS 10 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("HEAVY BLEEDING / ABNORMAL BLEEDING (GENERAL)"), MORPHOEA ("SCLEROSIS"), HEADACHE ("HEADACHES"), ALOPECIA ("HAIR LOSS"), SWELLING ("SWELLING"), ARTHRALGIA ("JOINT PAIN"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), NERVOUS SYSTEM DISORDER ("NEUROLOGICAL CONDITIONS"), URINARY TRACT INFECTION ("FREQUENT UTIS/INFECTION (BLADDER/URINARY TRACT/VAGINAL) - TYPE:"), HYPERSENSITIVITY ("HYPERSENSITIVITY REACTION"), DYSURIA ("DYSURIA"), ABDOMINAL PAIN LOWER ("LEFT LOWER QUADRANT PAIN"), FOLLICULITIS ("BACTERIAL FOLLICULITIS"), ACNE ("ADULT ACNE"), MEMORY IMPAIRMENT ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY PROBLEMS / DIFFICULTY REMEMBERING THINGS"), ALLERGY TO METALS ("NICKEL ALLERGY"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSPEPSIA ("DIGESTION ISSUES BECAME MUCH WORSE AFTER ESSURE PLACEMENT"), MENSTRUATION IRREGULAR ("PERIODS DATES BECAME EVEN MORE IRREGULAR AFTER ESSURE PLACEMENT"), MALAISE ("I BECAME SICK"), HYPOAESTHESIA ("NUMBNESS IN MY HANDS"), CENTRAL NERVOUS SYSTEM LESION ("LESIONS ON CERVICAL SPINE AND BRAIN"), FACTITIOUS DISORDER ("CHRONIC ILLNESS"), POLYCYTHAEMIA ("POLYCYTHEMIA"), VOMITING ("VOMITTING"), FLUSHING ("FLUSHING"), PAIN IN JAW ("JAW SORENESS"), PULMONARY HYPERTENSION ("PULMONARY HYPERTENSION/IDIOPATHIC") AND CARDIAC FAILURE CONGESTIVE ("CONGESTIVE HEART FAILURE"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MULTIPLE SCLEROSIS, MORPHOEA, HEADACHE, DEPRESSION, FATIGUE, ALOPECIA, SWELLING, ARTHRALGIA, RASH, VAGINAL HAEMORRHAGE, MENORRHAGIA, STAPHYLOCOCCAL INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, NAUSEA, NERVOUS SYSTEM DISORDER, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, WEIGHT INCREASED, URINARY TRACT INFECTION, HYPERSENSITIVITY, DYSURIA, ABDOMINAL PAIN LOWER, ANXIETY, FOLLICULITIS, ACNE, MEMORY IMPAIRMENT, ALLERGY TO METALS, AMNESIA, GINGIVAL BLEEDING, ABDOMINAL PAIN, MENSTRUATION IRREGULAR, BIOPSY ENDOMETRIUM, CYSTITIS, VAGINAL INFECTION, MALAISE, HYPOAESTHESIA, CENTRAL NERVOUS SYSTEM LESION, FACTITIOUS DISORDER, POLYCYTHAEMIA, VOMITING, FLUSHING, PAIN IN JAW, PULMONARY HYPERTENSION AND CARDIAC FAILURE CONGESTIVE OUTCOME WAS UNKNOWN AND THE DYSPEPSIA AND GASTRIC DISORDER HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ACNE, ALLERGY TO METALS, ALOPECIA, AMNESIA, ANXIETY, ARTHRALGIA, BIOPSY ENDOMETRIUM, BLADDER DISORDER, CARDIAC FAILURE CONGESTIVE, CENTRAL NERVOUS SYSTEM LESION, CYSTITIS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, DYSURIA, FACTITIOUS DISORDER, FATIGUE, FLUSHING, FOLLICULITIS, GASTRIC DISORDER, GENITAL HAEMORRHAGE, GINGIVAL BLEEDING, HEADACHE, HYPERSENSITIVITY, HYPOAESTHESIA, MALAISE, MEMORY IMPAIRMENT, MENORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, MORPHOEA, MULTIPLE SCLEROSIS, NAUSEA, NERVOUS SYSTEM DISORDER, PAIN IN JAW, PELVIC PAIN, POLYCYTHAEMIA, PULMONARY HYPERTENSION, RASH, STAPHYLOCOCCAL INFECTION, SWELLING, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VOMITING AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 155 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.6 KG/SQM. HYSTEROSALPINGOGRAM: ON (B)(6) 2011: RESULTS: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT: HEADACHES AND MULTIPLE SCLEROSIS, URINARY TRACT INFECTION,MENORRHAGIA,PELVIC PAIN, ANXIETY, MIGRAINES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-DEC-2019: PFS AND SOCIAL MEDIA RECEIVED. NEW EVENTS ENDOMETRIAL BIOPSY, BLADDER INFECTION, VAGINAL INFECTION WERE ADDED FROM PFS. NEW EVENTS FROM SOCIAL MEDIA I BECAME SICK, NUMBNESS IN MY HANDS, LESIONS ON MY CERVICAL SPINE AND BRAIN, CHRONIC ILLNESS, POLYCYTHEMIA, VOMITING, FLUSHING, JAW SORENESS, PULMONARY HYPERTENSION, CONGESTIVE HEART FAILURE WERE ADDED. INCIDENT: 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 PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MORPHOEA ("SCLEROSIS"), HEADACHE ("HEADACHES"), DEPRESSION ("DEPRESSION"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), SWELLING ("SWELLING"), ARTHRALGIA ("JOINT PAIN") AND RASH ("SKIN RASH"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MORPHOEA, HEADACHE, DEPRESSION, FATIGUE, ALOPECIA, SWELLING, ARTHRALGIA AND RASH OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, ARTHRALGIA, DEPRESSION, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MORPHOEA, PELVIC PAIN, RASH AND SWELLING TO BE RELATED TO ESSURE. 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. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. A PTC INVESTIGATION CANNOT BE PERFORMED AS NO BATCH NUMBER OR SAMPLE HAVE BEEN PROVIDED THUS RESULTING IN AN UNCONFIRMED QUALITY DEFECT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-MAY-2017: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. COMPANY CAUSALITY COMMENT: THIS LITIGATION CASE REPORT REFERS TO A FEMALE PLAINTIFF OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2011 AND REPORTED ADVERSE EVENTS INCLUDING PAIN (UNDERSTOOD AS PELVIC PAIN) AND HEAVY BLEEDING (UNDERSTOOD AS GENITAL HAEMORRHAGE). ON (B)(6) 2016, SHE UNDERWENT SURGERY AND ESSURE WAS REMOVED. CHRONIC PELVIC PAIN (CPP) AND GENITAL HEMORRHAGE ARE HIGHLY PREVALENT IN WOMEN, AND MAY HAVE MULTIPLE CAUSES. IN THIS CASE LIMITED INFORMATION WAS GIVEN FOR THE ABOVE MENTIONED EVENTS. THIS CASE WAS CLASSIFIED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED VIA SURGICAL INTERVENTION. A PRODUCT TECHNICAL INVESTIGATION CANNOT BE PERFORMED AS NO BATCH NUMBER OR SAMPLE HAVE BEEN PROVIDED THUS RESULTING IN AN UNCONFIRMED QUALITY DEFECT. FOLLOW-UP INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
/THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MORPHOEA ("SCLEROSIS"), HEADACHE ("HEADACHES"), DEPRESSION ("DEPRESSION"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), SWELLING ("SWELLING"), ARTHRALGIA ("JOINT PAIN") AND RASH ("SKIN RASH"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MORPHOEA, HEADACHE, DEPRESSION, FATIGUE, ALOPECIA, SWELLING, ARTHRALGIA AND RASH OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, ARTHRALGIA, DEPRESSION, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MORPHOEA, PELVIC PAIN, RASH AND SWELLING TO BE RELATED TO ESSURE. COMPANY CAUSALITY COMMENT: THIS LITIGATION CASE REPORT REFERS TO A FEMALE PLAINTIFF OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2011 AND REPORTED ADVERSE EVENTS INCLUDING PAIN (UNDERSTOOD AS PELVIC PAIN) AND HEAVY BLEEDING (UNDERSTOOD AS GENITAL HAEMORRHAGE). ON (B)(6) 2016, SHE UNDERWENT SURGERY AND ESSURE WAS REMOVED. CHRONIC PELVIC PAIN (CPP) AND GENITAL HEMORRHAGE ARE HIGHLY PREVALENT IN WOMEN, AND MAY HAVE MULTIPLE CAUSES. IN THIS CASE LIMITED INFORMATION WAS GIVEN FOR THE ABOVE MENTIONED EVENTS. THIS CASE WAS CLASSIFIED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED VIA SURGICAL INTERVENTION. A PRODUCT TECHNICAL ANALYSIS IS BEING SOUGHT. FOLLOW-UP INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291041 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 844600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other| R | BACLOFEN| BACLOFEN| BACLOFEN| BACLOFEN| GABAPENTINE| GILENYA| GILENYA| GILENYA| GILENYA| OMEPRAZOLE| OMEPRAZOLE| OMEPRAZOLE| OMEPRAZOLE| PRENATAL VITAMINS| PRENATAL VITAMINS| PRENATAL VITAMINS| PRENATAL VITAMINS [MINERALS NOS,VITAMINS NOS]| TRAMADOL| VENLAFAXINE| VENLAFAXINE| VENLAFAXINE| VENLAFAXINE |