ESSURE
Report
- Report Number
- 2951250-2019-07955
- Event Type
- Injury
- Date Received
- September 23, 2019
- Report Date
- November 2, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN / CHRONIC') AND AUTOIMMUNE THYROIDITIS ('AUTOIMMUNE DISORDER ¿ HASHIMOTO¿S/ HORMONAL CHANGES HASHIMOTO¿S') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872990) 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 "PLAINTIFF DID NOT UNDERWENT FOR ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED HASHIMOTO'S DISEASE. 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 ("GENERAL ABNORMAL BLEEDING"), AUTOIMMUNE THYROIDITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), HEADACHE ("HEADACHE"), BACK PAIN ("BACK PAIN"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), TOOTH DISORDER ("DENTAL PROBLEMS"), MIGRAINE ("MIGRAINE"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), NAUSEA ("NAUSEA,"), ECZEMA ("RASHES OR SKIN CONDITIONS ¿ ECZEMA"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND HYPERAESTHESIA TEETH ("TOOTH SENSITIVITY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (UNILATERAL). ESSURE WAS REMOVED ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, AUTOIMMUNE THYROIDITIS, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, VAGINAL HAEMORRHAGE, URINARY TRACT DISORDER, HEADACHE, BACK PAIN, BLADDER DISORDER, TOOTH DISORDER, MIGRAINE, FATIGUE, ALOPECIA, NAUSEA, ECZEMA, VAGINAL DISCHARGE, WEIGHT INCREASED AND HYPERAESTHESIA TEETH OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, AUTOIMMUNE THYROIDITIS, BACK PAIN, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, ECZEMA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERAESTHESIA TEETH, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR BLEEDING. DISCREPANCY NOTED IN ESSURE INSERTION AND REMOVAL. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: PFS RECEIVED -LOT NUMBER WAS ADDED. MEDICAL HISTORY WAS ADDED.SERIOUSNESS CRITERIA (MEDICALLY SIGNIFICANT) OF EVENT GENITAL HEMORRHAGE WAS REMOVED. 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 PELVIC PAIN ('PELVIC PAIN / CHRONIC') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872990) 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 "PLAINTIFF DID NOT UNDERWENT FOR ESSURE CONFIRMATION TEST." THE PATIENT'S MEDICAL HISTORY INCLUDED HASHIMOTO'S DISEASE. 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 ("GENERAL ABNORMAL BLEEDING"), AUTOIMMUNE THYROIDITIS ("AUTOIMMUNE DISORDER ¿ HASHIMOTO¿S/ HORMONAL CHANGES ¿ HASHIMOTO¿S"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA ((PAINFUL SEXUAL INTERCOURSE)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), HEADACHE ("HEADACHE"), BACK PAIN ("BACK PAIN"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), TOOTH DISORDER ("DENTAL PROBLEMS"), MIGRAINE ("MIGRAINE"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), NAUSEA ("NAUSEA,"), ECZEMA ("RASHES OR SKIN CONDITIONS ¿ ECZEMA"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND HYPERAESTHESIA TEETH ("TOOTH SENSITIVITY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (UNILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, AUTOIMMUNE THYROIDITIS, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, VAGINAL HAEMORRHAGE, URINARY TRACT DISORDER, HEADACHE, BACK PAIN, BLADDER DISORDER, TOOTH DISORDER, MIGRAINE, FATIGUE, ALOPECIA, NAUSEA, ECZEMA, VAGINAL DISCHARGE, WEIGHT INCREASED AND HYPERAESTHESIA TEETH OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, AUTOIMMUNE THYROIDITIS, BACK PAIN, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, ECZEMA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERAESTHESIA TEETH, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR BLEEDING. DISCREPANCY NOTED IN ESSURE INSERTION AND REMOVAL. LOT NUMBER: 872990 MANUFACTURE DATE: 2011-06 EXPIRATION DATE: 2014-06. 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. 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 PELVIC PAIN ('PELVIC PAIN / CHRONIC') IN A 21-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872990) 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 "PLAINTIFF DID NOT UNDERWENT FOR ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED HASHIMOTO'S DISEASE, PARITY 2, PENICILLIN ALLERGY, PRENATAL CARE, UTERINE BLEEDING, ACNE AND POLYCYSTIC OVARIAN SYNDROME. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO PROVERA. CONCOMITANT PRODUCTS INCLUDED LEVOTHYROXINE, METFORMIN AND SPIRONOLACTONE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 1 MONTH 23 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA ((PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2013, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"), ECZEMA ("RASHES OR SKIN CONDITIONS ¿ ECZEMA") AND DYSURIA ("INFECTION-UTI-BURNING SENSATION WHILE URINATING"). ON (B)(6) 2016, THE PATIENT EXPERIENCED AUTOIMMUNE THYROIDITIS ("AUTOIMMUNE DISORDER ¿ HASHIMOTO¿S/ HORMONAL CHANGES ¿ HASHIMOTO¿S"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), HEADACHE ("HEADACHE"), BACK PAIN ("BACK PAIN"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINE / HEADACHE"), HYPERAESTHESIA TEETH ("TOOTH SENSITIVITY"), ENDOMETRIOSIS ("ENDOMETRISIS"), UTERINE POLYP ("UTERINE POLYPS"), COMPLICATION OF DEVICE INSERTION ("DUE TO THE VARIOUS POLYPS I HAD IN MY UTERUS, THE DOCTOR WAS ONLY ABLE TO DEPLOY THE COILS INTO MY RIGHT TUBE") AND POLLAKIURIA ("INFECTION-UTI- MORE FREQUENT URINATION"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (UNILATERAL), D AND C WITH POLYPECTOMY). ESSURE WAS REMOVED ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA AND ENDOMETRIOSIS HAD RESOLVED, THE AUTOIMMUNE THYROIDITIS, ABDOMINAL PAIN, DYSPAREUNIA, MENORRHAGIA, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION, HEADACHE, BACK PAIN, BLADDER DISORDER, TOOTH DISORDER, FATIGUE, ALOPECIA, NAUSEA, ECZEMA, VAGINAL DISCHARGE, WEIGHT INCREASED, HYPERAESTHESIA TEETH, UTERINE POLYP, DYSURIA, COMPLICATION OF DEVICE INSERTION AND POLLAKIURIA OUTCOME WAS UNKNOWN AND THE MIGRAINE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, AUTOIMMUNE THYROIDITIS, BACK PAIN, BLADDER DISORDER, COMPLICATION OF DEVICE INSERTION, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, ECZEMA, ENDOMETRIOSIS, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERAESTHESIA TEETH, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, POLLAKIURIA, TOOTH DISORDER, URINARY TRACT INFECTION, UTERINE POLYP, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR BLEEDING. DISCREPANCY NOTED IN ESSURE INSERTION WAS (B)(6) 2011 AND REMOVAL WAS (B)(6) 2020 CURRENT WEIGHT 200 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.9 KG/SQM. LOT NUMBER: 872990 MANUFACTURE DATE: 2011-06 EXPIRATION DATE: 2014-06. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-OCT-2020: PFS RECEIVED EVENT " MORE FREQUENT URINATION" WAS ADDED. PATIENT DEMOGRAPHICS AND RCC 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 PELVIC PAIN ('PELVIC PAIN / CHRONIC') IN A 21-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872990) 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 "PLAINTIFF DID NOT UNDERWENT FOR ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED HASHIMOTO'S DISEASE, PARITY 2, PENICILLIN ALLERGY, PRENATAL CARE, UTERINE BLEEDING, ACNE AND POLYCYSTIC OVARIAN SYNDROME. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO PROVERA. CONCOMITANT PRODUCTS INCLUDED LEVOTHYROXINE, METFORMIN AND SPIRONOLACTONE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 1 MONTH 23 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA ((PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2013, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"), ECZEMA ("RASHES OR SKIN CONDITIONS ¿ ECZEMA") AND DYSURIA ("INFECTION-UTI-BURNING SENSATION WHILE URINATING"). ON (B)(6) 2016, THE PATIENT EXPERIENCED AUTOIMMUNE THYROIDITIS ("AUTOIMMUNE DISORDER ¿ HASHIMOTO¿S/ HORMONAL CHANGES ¿ HASHIMOTO¿S"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), HEADACHE ("HEADACHE"), BACK PAIN ("BACK PAIN"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINE / HEADACHE"), HYPERAESTHESIA TEETH ("TOOTH SENSITIVITY"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), UTERINE POLYP ("UTERINE POLYPS") AND COMPLICATION OF DEVICE INSERTION ("DUE TO THE VARIOUS POLYPS I HAD IN MY UTERUS, THE DOCTOR WAS ONLY ABLE TO DEPLOY THE COILS INTO MY RIGHT TUBE"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (UNILATERAL), D AND C WITH POLYPECTOMY). ESSURE WAS REMOVED ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA AND ENDOMETRIOSIS HAD RESOLVED, THE AUTOIMMUNE THYROIDITIS, ABDOMINAL PAIN, DYSPAREUNIA, MENORRHAGIA, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION, HEADACHE, BACK PAIN, BLADDER DISORDER, TOOTH DISORDER, FATIGUE, ALOPECIA, NAUSEA, ECZEMA, VAGINAL DISCHARGE, WEIGHT INCREASED, HYPERAESTHESIA TEETH, UTERINE POLYP, DYSURIA AND COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN AND THE MIGRAINE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, AUTOIMMUNE THYROIDITIS, BACK PAIN, BLADDER DISORDER, COMPLICATION OF DEVICE INSERTION, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, ECZEMA, ENDOMETRIOSIS, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERAESTHESIA TEETH, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, TOOTH DISORDER, URINARY TRACT INFECTION, UTERINE POLYP, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR BLEEDING. DISCREPANCY NOTED IN ESSURE INSERTION AND REMOVAL. LOT NUMBER: 872990, MANUFACTURE DATE: 2011-06, EXPIRATION DATE: 2014-06. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-AUG-2020: PFS RECEIVED : NEW EVENTS - ENDOMETRIOSIS, DYSURIA, UTERINE POLYPS AND DUE TO THE VARIOUS POLYPS I HAD IN MY UTERUS, THE DOCTOR WAS ONLY ABLE TO DEPLOY THE COILS INTO MY RIGHT TUBE. PREVIOUSLY REPORTED EVENT OF URINARY TRACT DISORDER UPDATED TO UTI. MEDICAL HISTORY AND CONCOMITANT MEDICATION ADDED AND OUTCOME FOR ABNORMAL BLEEDING, PAIN, DYSMENORRHEA, MIGRAINES AND ENDOMETRIOSIS UPDATED AND EVENT ONSET DATE AND STOP DATE 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 PELVIC PAIN ('PELVIC PAIN / CHRONIC'), GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') AND AUTOIMMUNE THYROIDITIS ('AUTOIMMUNE DISORDER ¿ HASHIMOTO¿S/ HORMONAL CHANGES ¿ HASHIMOTO¿S') IN AN ADULT 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 "PLAINTIFF DID NOT UNDERWENT FOR ESSURE CONFIRMATION TEST". 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), AUTOIMMUNE THYROIDITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA ((PAINFUL SEXUAL INTERCOURSE)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), HEADACHE ("HEADACHE"), BACK PAIN ("BACK PAIN"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), TOOTH DISORDER ("DENTAL PROBLEMS"), MIGRAINE ("MIGRAINE"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), NAUSEA ("NAUSEA,"), ECZEMA ("RASHES OR SKIN CONDITIONS ¿ ECZEMA"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND HYPERAESTHESIA TEETH ("TOOTH SENSITIVITY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (UNILATERAL)). ESSURE WAS REMOVED ON (B)(6)2011. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, AUTOIMMUNE THYROIDITIS, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, VAGINAL HAEMORRHAGE, URINARY TRACT DISORDER, HEADACHE, BACK PAIN, BLADDER DISORDER, TOOTH DISORDER, MIGRAINE, FATIGUE, ALOPECIA, NAUSEA, ECZEMA, VAGINAL DISCHARGE, WEIGHT INCREASED AND HYPERAESTHESIA TEETH OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, AUTOIMMUNE THYROIDITIS, BACK PAIN, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, ECZEMA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERAESTHESIA TEETH, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR BLEEDING. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-NOV-2019: NEW PFS RECEIVED- NEW EVENTS ADDED: ABNORMAL BLEEDING (VAGINAL), AUTOIMMUNE DISORDER ¿ HASHIMOTO¿S, BLADDER OR URINARY PROBLEMS OR CHANGES, DENTAL PROBLEMS, DYSPAREUNIA, FATIGUE, HAIR LOSS, HEADACHES, NAUSEA, OR SKIN CONDITIONS ¿ ECZEMA, VAGINAL DISCHARGE, WEIGHT GAIN , BACK PAIN, TOOTH SENSITIVITY, PLAINTIFF DID NOT UNDERWENT FOR ESSURE CONFIRMATION TEST. NEW REPORTERS INFORMATION WAS ADDED. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN / CHRONIC') IN A 21-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872990) 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 "PLAINTIFF DID NOT UNDERWENT FOR ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED HASHIMOTO'S DISEASE, PARITY 2, PENICILLIN ALLERGY, PRENATAL CARE, UTERINE BLEEDING, ACNE AND POLYCYSTIC OVARIAN SYNDROME. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO PROVERA. CONCOMITANT PRODUCTS INCLUDED LEVOTHYROXINE, METFORMIN AND SPIRONOLACTONE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 1 MONTH 23 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA ((PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2013, THE PATIENT EXPERIENCED THE FIRST EPISODE OF HYPERAESTHESIA TEETH ("DENTAL PROBLEMS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"), ECZEMA ("RASHES OR SKIN CONDITIONS ¿ ECZEMA") AND DYSURIA ("INFECTION-UTI-BURNING SENSATION WHILE URINATING"). ON (B)(6) 2016, THE PATIENT EXPERIENCED AUTOIMMUNE THYROIDITIS ("AUTOIMMUNE DISORDER ¿ HASHIMOTO¿S/ HORMONAL CHANGES ¿ HASHIMOTO¿S"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), HEADACHE ("HEADACHE"), BACK PAIN ("BACK PAIN"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINE / HEADACHE"), THE SECOND EPISODE OF HYPERAESTHESIA TEETH ("TOOTH SENSITIVITY"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), UTERINE POLYP ("UTERINE POLYPS"), COMPLICATION OF DEVICE INSERTION ("DUE TO THE VARIOUS POLYPS I HAD IN MY UTERUS, THE DOCTOR WAS ONLY ABLE TO DEPLOY THE COILS INTO MY RIGHT TUBE") AND POLLAKIURIA ("INFECTION-UTI- MORE FREQUENT URINATION"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (UNILATERAL), D AND C WITH POLYPECTOMY). ESSURE WAS REMOVED ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA AND ENDOMETRIOSIS HAD RESOLVED, THE AUTOIMMUNE THYROIDITIS, ABDOMINAL PAIN, DYSPAREUNIA, MENORRHAGIA, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION, HEADACHE, BACK PAIN, BLADDER DISORDER, FATIGUE, ALOPECIA, NAUSEA, ECZEMA, VAGINAL DISCHARGE, WEIGHT INCREASED, THE LAST EPISODE OF HYPERAESTHESIA TEETH, UTERINE POLYP, DYSURIA, COMPLICATION OF DEVICE INSERTION AND POLLAKIURIA OUTCOME WAS UNKNOWN AND THE MIGRAINE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, AUTOIMMUNE THYROIDITIS, BACK PAIN, BLADDER DISORDER, COMPLICATION OF DEVICE INSERTION, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, ECZEMA, ENDOMETRIOSIS, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, POLLAKIURIA, URINARY TRACT INFECTION, UTERINE POLYP, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, THE FIRST EPISODE OF HYPERAESTHESIA TEETH AND THE SECOND EPISODE OF HYPERAESTHESIA TEETH TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR BLEEDING. DISCREPANCY NOTED IN ESSURE INSERTION WAS (B)(6) 2011 AND REMOVAL WAS (B)(6) 2020 CURRENT WEIGHT 200 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.9 KG/SQM. LOT NUMBER: 872990 MANUFACTURE DATE: 2011-06 EXPIRATION DATE: 2014-06. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-OCT-2020: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 PELVIC PAIN ('PELVIC PAIN / CHRONIC') IN A 21-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872990) 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 "PLAINTIFF DID NOT UNDERWENT FOR ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED HASHIMOTO'S DISEASE, PARITY 2, PENICILLIN ALLERGY, PRENATAL CARE, UTERINE BLEEDING, ACNE AND POLYCYSTIC OVARIAN SYNDROME. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO PROVERA. CONCOMITANT PRODUCTS INCLUDED LEVOTHYROXINE, METFORMIN AND SPIRONOLACTONE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 1 MONTH 23 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA ((PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2013, THE PATIENT EXPERIENCED THE FIRST EPISODE OF HYPERAESTHESIA TEETH ("DENTAL PROBLEMS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"), ECZEMA ("RASHES OR SKIN CONDITIONS ¿ ECZEMA") AND DYSURIA ("INFECTION-UTI-BURNING SENSATION WHILE URINATING"). ON (B)(6) 2016, THE PATIENT EXPERIENCED AUTOIMMUNE THYROIDITIS ("AUTOIMMUNE DISORDER ¿ HASHIMOTO¿S/ HORMONAL CHANGES ¿ HASHIMOTO¿S"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), HEADACHE ("HEADACHE"), BACK PAIN ("BACK PAIN"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINE / HEADACHE"), THE SECOND EPISODE OF HYPERAESTHESIA TEETH ("TOOTH SENSITIVITY"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), UTERINE POLYP ("UTERINE POLYPS"), COMPLICATION OF DEVICE INSERTION ("DUE TO THE VARIOUS POLYPS I HAD IN MY UTERUS, THE DOCTOR WAS ONLY ABLE TO DEPLOY THE COILS INTO MY RIGHT TUBE") AND POLLAKIURIA ("INFECTION-UTI- MORE FREQUENT URINATION"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (UNILATERAL), D AND C WITH POLYPECTOMY). ESSURE WAS REMOVED ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA AND ENDOMETRIOSIS HAD RESOLVED, THE AUTOIMMUNE THYROIDITIS, ABDOMINAL PAIN, DYSPAREUNIA, MENORRHAGIA, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION, HEADACHE, BACK PAIN, BLADDER DISORDER, FATIGUE, ALOPECIA, NAUSEA, ECZEMA, VAGINAL DISCHARGE, WEIGHT INCREASED, THE LAST EPISODE OF HYPERAESTHESIA TEETH, UTERINE POLYP, DYSURIA, COMPLICATION OF DEVICE INSERTION AND POLLAKIURIA OUTCOME WAS UNKNOWN AND THE MIGRAINE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, AUTOIMMUNE THYROIDITIS, BACK PAIN, BLADDER DISORDER, COMPLICATION OF DEVICE INSERTION, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, ECZEMA, ENDOMETRIOSIS, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, POLLAKIURIA, URINARY TRACT INFECTION, UTERINE POLYP, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, THE FIRST EPISODE OF HYPERAESTHESIA TEETH AND THE SECOND EPISODE OF HYPERAESTHESIA TEETH TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR BLEEDING. DISCREPANCY NOTED IN ESSURE INSERTION WAS (B)(6) 2011 AND REMOVAL WAS (B)(6) 2020 CURRENT WEIGHT 200 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.9 KG/SQM. LOT NUMBER: 872990 MANUFACTURE DATE: 2011-06 EXPIRATION DATE: 2014-06. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-NOV-2020: QUALITY-SAFETY EVALUATION OF PTC(PRODUCT TECHNICAL COMPLAINT). 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 PELVIC PAIN ('PELVIC PAIN / CHRONIC') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE 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), MIGRAINE ("MIGRAINE"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (UNILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MIGRAINE, DYSMENORRHOEA, ABDOMINAL PAIN AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR BLEEDING. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-SEP-2019: PFS RECEIVED. EVENTS : CHRONIC, DYSMENORRHEA (CRAMPING),PELVIC/ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING),GENERAL ABNORMAL BLEEDING, MIGRAINE WERE ADDED. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 897889 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 872990 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Other| R | LEVOTHYROXINE| LEVOTHYROXINE| LEVOTHYROXINE| LEVOTHYROXINE| METFORMIN| METFORMIN| METFORMIN| METFORMIN| SPIRONOLACTONE| SPIRONOLACTONE| SPIRONOLACTONE| SPIRONOLACTONE |