ESSURE
Report
- Report Number
- 2951250-2019-11416
- Event Type
- Injury
- Date Received
- November 12, 2019
- Date of Event
- December 1, 2015
- Report Date
- May 7, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ENDOMETRITIS ('CHRONIC ENDOMETRITIS') AND MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C59250, 001873) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ANXIETY AND DYSMENORRHOEA. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY, HYPERMENORRHEA, ANEMIA, UTERINE FIBROID, ENDOMETRIAL POLYP, BURNING MICTURITION, HSV INFECTION, ENDOMETRIAL ABLATION AND D & C. CONCOMITANT PRODUCTS INCLUDED DULOXETINE HYDROCHLORIDE (CYMBALTA) SINCE (B)(6) 2014 FOR ANXIETY, CEFIXIME (FLEXERIL) SINCE (B)(6) 2015 FOR DYSMENORRHEA, PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2015 FOR PELVIC PAIN AS WELL AS BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE (B)(6) 2015, FENTANYL CITRATE (NARCO) SINCE (B)(6) 2015 AND NSAIDS SINCE (B)(6) 2015. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"), 10 MONTHS 9 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PHYSICAL PAIN / PELVIC PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DYSPAREUNIA ("DYSPAREUNIA"), FATIGUE ("FATIGUE"), MOOD SWINGS ("HORMONAL CHANGES, MOOD SWINGS"), VAGINAL INFECTION ("INFECTION (BLADDER/URINARY TRACT/ VAGINAL)- TYPE: VAGINAL"), MIGRAINE ("MIGRAINES/HEADACHES") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/LOSS (SPECIFY WHICH ONE) WEIGHT GAIN. "). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GEN ABNORMAL. BLEED"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DEPRESSION ("PSYCH INJURY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS, DEPRESSION"), DYSURIA ("URINARY PROBS"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY") AND BACK PAIN ("LOWER BACK AREA"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE ENDOMETRITIS, MENORRHAGIA, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DEPRESSION, DYSURIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MOOD SWINGS, VAGINAL INFECTION, MIGRAINE, ANXIETY, VAGINAL DISCHARGE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, ENDOMETRITIS, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE OF INSERTION (B)(6) 2014 (SUMMONS) AND (B)(6) 2015 (PFS) PATIENT RECEIVED TREATMENT FOR PELVIC/ABDOMINAL, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GEN ABNORMAL. BLEED, PSYCH INJURY, URINARY PROBS. RECEIVED TREATMENT FOR BLEEDING, BLADDER/ URINARY PROBLEM. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 44.3 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. PATHOLOGY TEST - ON AN UNKNOWN DATE: PROLIFERATIVE PHASE ENDOMETRIUM WITH CHRONIC ENDOMETRITIS. FRAGMENTS OF BENIGN ENDOMETRIAL POLYP. FRAGMENTS OF ECTOCERVICAL AND ENDOCERVICAL MUCOSA WITH ACUTE AND CHRONIC CERVICITIS AND REACTIVE EPITHELIAL CHANGES. NO HYPERPLASIA OR MALIGNANCY IDENTIFIED.. LOT NUMBER REPORTED ( C69280, D01873 ) IS NOT VALID. LOT NUMBERS: LEFT-C59250, RIGHT-001873. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2020: PIF RECEIVED- LOT NUMBER WAS ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ENDOMETRITIS ('CHRONIC ENDOMETRITIS'), EMBEDDED DEVICE ('SECOND IS FOUND EMBEDDED 3 CM FROM THE LEFT CORNU WITH ENDOMYOMETRIUM (RIGHT)') AND MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. (C69280,D01873)INV,C59250) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ANXIETY AND DYSMENORRHOEA. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY, HYPERMENORRHEA, ANEMIA, UTERINE FIBROID, ENDOMETRIAL POLYP, BURNING MICTURITION, HSV INFECTION, ENDOMETRIAL ABLATION AND D & C. CONCOMITANT PRODUCTS INCLUDED DULOXETINE HYDROCHLORIDE (CYMBALTA) SINCE (B)(6) 2014 FOR ANXIETY, CEFIXIME (FLEXERIL) SINCE (B)(6) 2015 FOR DYSMENORRHEA, PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2015 FOR PELVIC PAIN AS WELL AS BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE (B)(6) 2015, FENTANYL CITRATE (NARCO) SINCE (B)(6) 2015 AND NSAIDS SINCE (B)(6) 2015. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"), 10 MONTHS 9 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PHYSICAL PAIN / PELVIC PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DYSPAREUNIA ("DYSPAREUNIA"), FATIGUE ("FATIGUE"), MOOD SWINGS ("HORMONAL CHANGES, MOOD SWINGS"), VAGINAL INFECTION ("INFECTION (BLADDER/URINARY TRACT/ VAGINAL)- TYPE: VAGINAL"), MIGRAINE ("MIGRAINES/HEADACHES") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/LOSS (SPECIFY WHICH ONE) WEIGHT GAIN. "). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GEN ABNORMAL. BLEED"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DEPRESSION ("PSYCH INJURY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS, DEPRESSION"), DYSURIA ("URINARY PROBS"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY") AND BACK PAIN ("LOWER BACK AREA"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL ABDOMINAL HYSTERECTOMY BILIATERAL SALPINGECTOMY AND ABLATION). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE ENDOMETRITIS, EMBEDDED DEVICE, MENORRHAGIA, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DEPRESSION, DYSURIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MOOD SWINGS, VAGINAL INFECTION, MIGRAINE, ANXIETY, VAGINAL DISCHARGE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, EMBEDDED DEVICE, ENDOMETRITIS, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE OF INSERTION (B)(6) 2014 (SUMMONS) AND (B)(6) 2015 (PFS). PATIENT RECEIVED TREATMENT FOR PELVIC/ABDOMINAL, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GEN ABNORMAL. BLEED, PSYCH INJURY, URINARY PROBS. RECEIVED TREATMENT FOR BLEEDING, BLADDER/ URINARY PROBLEM. 001873 WAS ALSO MENTIONED AS LOT NUMBER (NOT VALID). 1 TRAILING COIL AT BOTH END . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 44.3 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. PATHOLOGY TEST - ON AN UNKNOWN DATE: PROLIFERATIVE PHASE ENDOMETRIUM WITH CHRONIC ENDOMETRITIS. FRAGMENTS OF BENIGN ENDOMETRIAL POLYP. FRAGMENTS OF ECTOCERVICAL AND ENDOCERVICAL MUCOSA WITH ACUTE AND CHRONIC CERVICITIS AND REACTIVE EPITHELIAL CHANGES. NO HYPERPLASIA OR MALIGNANCY IDENTIFIED.. LOT NUMBER REPORTED ( C69280, D01873 ) IS NOT VALID. LOT NUMBERS: LEFT-C59250, RIGHT-001873. LOT NUMBERS (001873, C69280, D01873 ) ARE NOT VALID. LOT NUMBER: C59250, MANUFACTURING DATE: 2014-05, EXPIRATION DATE: 2017-05. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-APR-2021: MR RECEIVED : EVENT "SECOND IS FOUND EMBEDDED 3 CM FROM THE LEFT CORNU WITH ENDOMYOMETRIUM (RIGHT)", REPORTER ADDED. ESSURE REMOVAL REPORTED. 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 ENDOMETRITIS ('CHRONIC ENDOMETRITIS'), EMBEDDED DEVICE ('SECOND IS FOUND EMBEDDED 3 CM FROM THE LEFT CORNU WITH ENDOMYOMETRIUM (RIGHT)') AND HEAVY MENSTRUAL BLEEDING ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C59250 , D01973) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ANXIETY AND DYSMENORRHOEA. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY, HYPERMENORRHEA, ANEMIA, UTERINE FIBROID, ENDOMETRIAL POLYP, BURNING MICTURITION, HSV INFECTION, ENDOMETRIAL ABLATION AND D & C. CONCOMITANT PRODUCTS INCLUDED DULOXETINE HYDROCHLORIDE (CYMBALTA) SINCE (B)(6) 2014 FOR ANXIETY, CEFIXIME (FLEXERIL) SINCE (B)(6) 2015 FOR DYSMENORRHEA, PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2015 FOR PELVIC PAIN AS WELL AS BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE (B)(6) 2015, FENTANYL CITRATE (NARCO) SINCE (B)(6) 2015 AND NSAIDS SINCE (B)(6) 2015. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"), 10 MONTHS 9 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2015, THE PATIENT EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PHYSICAL PAIN / PELVIC PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DYSPAREUNIA ("DYSPAREUNIA"), FATIGUE ("FATIGUE"), MOOD SWINGS ("HORMONAL CHANGES, MOOD SWINGS"), VAGINAL INFECTION ("INFECTION (BLADDER/URINARY TRACT/ VAGINAL)- TYPE: VAGINAL"), MIGRAINE ("MIGRAINES/HEADACHES") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/LOSS (SPECIFY WHICH ONE) WEIGHT GAIN. "). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GEN ABNORMAL. BLEED"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DEPRESSION ("PSYCH INJURY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS, DEPRESSION"), DYSURIA ("URINARY PROBS"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY") AND BACK PAIN ("LOWER BACK AREA"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL ABDOMINAL HYSTERECTOMY BILIATERAL SALPINGECTOMY AND ABLATION). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE ENDOMETRITIS, EMBEDDED DEVICE, HEAVY MENSTRUAL BLEEDING, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DEPRESSION, DYSURIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MOOD SWINGS, VAGINAL INFECTION, MIGRAINE, ANXIETY, VAGINAL DISCHARGE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, EMBEDDED DEVICE, ENDOMETRITIS, FATIGUE, GENITAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, MIGRAINE, MOOD SWINGS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE OF INSERTION (B)(6) 2014 (SUMMONS) AND (B)(6) 2015 (PFS) PATIENT RECEIVED TREATMENT FOR PELVIC/ABDOMINAL, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GEN ABNORMAL. BLEED, PSYCH INJURY, URINARY PROBS. RECEIVED TREATMENT FOR BLEEDING, BLADDER/ URINARY PROBLEM. 001873 WAS ALSO MENTIONED AS LOT NUMBER (NOT VALID). 1 TRAILING COIL AT BOTH END. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 44.3 KG/SQM. HYSTEROSALPINGOGRAM ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. PATHOLOGY TEST ON AN UNKNOWN DATE: PROLIFERATIVE PHASE ENDOMETRIUM WITH CHRONIC ENDOMETRITIS. FRAGMENTS OF BENIGN ENDOMETRIAL POLYP. FRAGMENTS OF ECTOCERVICAL AND ENDOCERVICAL MUCOSA WITH ACUTE AND CHRONIC CERVICITIS AND REACTIVE EPITHELIAL CHANGES. NO HYPERPLASIA OR MALIGNANCY IDENTIFIED. LOT NUMBER REPORTED ( C69280, D01873 ) IS NOT VALID. LOT NUMBERS: LEFT-C59250, RIGHT-001873. LOT NUMBERS (001873, C69280, D01873 ) ARE NOT VALID. LOT NUMBER: C59250 MANUFACTURING DATE: 2014-05 EXPIRATION DATE: 2017-05. LOT NUMBERS (001873, C69280, D01873 ) ARE INVALID. BATCH NO C59250 PRODUCTION DATE 2014-05-23. EXPIRATION DATE 2017-05-31. BATCH NO D01973 PRODUCTION DATE 2014-08-26. EXPIRATION DATE 2017-08-31 . QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: QUALITY SAFETY EVALUATION OF PTC. 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 ENDOMETRITIS ('CHRONIC ENDOMETRITIS') AND MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. (C69280,D01873)INV,C59250) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ANXIETY AND DYSMENORRHOEA. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY, HYPERMENORRHEA, ANEMIA, UTERINE FIBROID, ENDOMETRIAL POLYP, BURNING MICTURITION, HSV INFECTION, ENDOMETRIAL ABLATION AND D & C. CONCOMITANT PRODUCTS INCLUDED DULOXETINE HYDROCHLORIDE (CYMBALTA) SINCE (B)(6) 2014 FOR ANXIETY, CEFIXIME (FLEXERIL) SINCE (B)(6) 2015 FOR DYSMENORRHEA, PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2015 FOR PELVIC PAIN AS WELL AS BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE (B)(6) 2015, FENTANYL CITRATE (NARCO) SINCE (B)(6) 2015 AND NSAIDS SINCE (B)(6) 2015. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"), 10 MONTHS 9 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PHYSICAL PAIN / PELVIC PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DYSPAREUNIA ("DYSPAREUNIA"), FATIGUE ("FATIGUE"), MOOD SWINGS ("HORMONAL CHANGES, MOOD SWINGS"), VAGINAL INFECTION ("INFECTION (BLADDER/URINARY TRACT/ VAGINAL)- TYPE: VAGINAL"), MIGRAINE ("MIGRAINES/HEADACHES") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/LOSS (SPECIFY WHICH ONE) WEIGHT GAIN. "). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GEN ABNORMAL. BLEED"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DEPRESSION ("PSYCH INJURY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS, DEPRESSION"), DYSURIA ("URINARY PROBS"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY") AND BACK PAIN ("LOWER BACK AREA"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE ENDOMETRITIS, MENORRHAGIA, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DEPRESSION, DYSURIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MOOD SWINGS, VAGINAL INFECTION, MIGRAINE, ANXIETY, VAGINAL DISCHARGE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, ENDOMETRITIS, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE OF INSERTION (B)(6) 2014 (SUMMONS) AND (B)(6) 2015 (PFS) PATIENT RECEIVED TREATMENT FOR PELVIC/ABDOMINAL, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GEN ABNORMAL. BLEED, PSYCH INJURY, URINARY PROBS. RECEIVED TREATMENT FOR BLEEDING, BLADDER/ URINARY PROBLEM. 001873 WAS ALSO MENTIONED AS LIT NUMBER (INVALID). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 44.3 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. PATHOLOGY TEST - ON AN UNKNOWN DATE: PROLIFERATIVE PHASE ENDOMETRIUM WITH CHRONIC ENDOMETRITIS. FRAGMENTS OF BENIGN ENDOMETRIAL POLYP. FRAGMENTS OF ECTOCERVICAL AND ENDOCERVICAL MUCOSA WITH ACUTE AND CHRONIC CERVICITIS AND REACTIVE EPITHELIAL CHANGES. NO HYPERPLASIA OR MALIGNANCY IDENTIFIED.. LOT NUMBER REPORTED ( C69280, D01873 ) IS NOT VALID. LOT NUMBERS: LEFT-C59250, RIGHT-001873. LOT NUMBERS (001873, C69280, D01873 ) ARE NOT VALID. LOT NUMBER: C59250. MANUFACTURING DATE: 2014-05. EXPIRATION DATE: 2017-05. 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. ON (B)(6) 2020: AMENDMENT: LOT NUMBER FIELD UPDATED (ONLY NUMBER OF CHARACTERS). 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 ENDOMETRITIS ('CHRONIC ENDOMETRITIS'), MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING') AND GENITAL HAEMORRHAGE ('GEN ABNORMAL. BLEED') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C69280, D01873-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ANXIETY AND DYSMENORRHOEA. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY, HYPERMENORRHEA, ANEMIA, UTERINE FIBROID, ENDOMETRIAL POLYP, BURNING MICTURITION, HSV INFECTION, ENDOMETRIAL ABLATION AND D & C. CONCOMITANT PRODUCTS INCLUDED DULOXETINE HYDROCHLORIDE (CYMBALTA) SINCE (B)(6) 2014 FOR ANXIETY, CEFIXIME (FLEXERIL) SINCE (B)(6) 2015 FOR DYSMENORRHEA, PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2015 FOR PELVIC PAIN AS WELL AS BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE (B)(6) 2015, FENTANYL CITRATE (NARCO) SINCE (B)(6) 2015 AND NSAIDS SINCE (B)(6) 2015. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"), 10 MONTHS 9 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PHYSICAL PAIN / PELVIC PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DYSPAREUNIA ("DYSPAREUNIA"), FATIGUE ("FATIGUE"), MOOD SWINGS ("HORMONAL CHANGES, MOOD SWINGS"), VAGINAL INFECTION ("INFECTION (BLADDER/URINARY TRACT/ VAGINAL)- TYPE: VAGINAL"), MIGRAINE ("MIGRAINES/HEADACHES") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/LOSS (SPECIFY WHICH ONE) WEIGHT GAIN. "). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DEPRESSION ("PSYCH INJURY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS, DEPRESSION"), DYSURIA ("URINARY PROBS"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY") AND BACK PAIN ("LOWER BACK AREA"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DEPRESSION, DYSURIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MOOD SWINGS, VAGINAL INFECTION, MIGRAINE, ANXIETY, VAGINAL DISCHARGE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, ENDOMETRITIS, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE OF INSERTION (B)(6) 2014 (SUMMONS) AND (B)(6) 2015 (PFS). PATIENT RECEIVED TREATMENT FOR PELVIC/ABDOMINAL, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GEN ABNORMAL. BLEED, PSYCH INJURY, URINARY PROBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 44.3 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. PATHOLOGY TEST - ON AN UNKNOWN DATE: PROLIFERATIVE PHASE ENDOMETRIUM WITH CHRONIC ENDOMETRITIS. FRAGMENTS OF BENIGN ENDOMETRIAL POLYP. FRAGMENTS OF ECTOCERVICAL AND ENDOCERVICAL MUCOSA WITH ACUTE AND CHRONIC CERVICITIS AND REACTIVE EPITHELIAL CHANGES. NO HYPERPLASIA OR MALIGNANCY IDENTIFIED. LOT NUMBER REPORTED ( C69280, D01873 ) IS INVALID. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-NOV-2019: UPDATE OF INFORMATION (BATCH IS INVALID) WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ENDOMETRITIS ('CHRONIC ENDOMETRITIS') AND MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 001873- INV C59250,) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ANXIETY AND DYSMENORRHOEA. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY, HYPERMENORRHEA, ANEMIA, UTERINE FIBROID, ENDOMETRIAL POLYP, BURNING MICTURITION, HSV INFECTION, ENDOMETRIAL ABLATION AND D & C. CONCOMITANT PRODUCTS INCLUDED DULOXETINE HYDROCHLORIDE (CYMBALTA) SINCE (B)(6) 2014 FOR ANXIETY, CEFIXIME (FLEXERIL) SINCE (B)(6) 2015 FOR DYSMENORRHEA, PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2015 FOR PELVIC PAIN AS WELL AS BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE (B)(6) 2015, FENTANYL CITRATE (NARCO) SINCE (B)(6) 2015 AND NSAIDS SINCE (B)(6) 2015. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"), 10 MONTHS 9 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PHYSICAL PAIN / PELVIC PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DYSPAREUNIA ("DYSPAREUNIA"), FATIGUE ("FATIGUE"), MOOD SWINGS ("HORMONAL CHANGES, MOOD SWINGS"), VAGINAL INFECTION ("INFECTION (BLADDER/URINARY TRACT/ VAGINAL)- TYPE: VAGINAL"), MIGRAINE ("MIGRAINES/HEADACHES") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/LOSS (SPECIFY WHICH ONE) WEIGHT GAIN. "). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GEN ABNORMAL. BLEED"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DEPRESSION ("PSYCH INJURY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS, DEPRESSION"), DYSURIA ("URINARY PROBS"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY") AND BACK PAIN ("LOWER BACK AREA"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE ENDOMETRITIS, MENORRHAGIA, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DEPRESSION, DYSURIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MOOD SWINGS, VAGINAL INFECTION, MIGRAINE, ANXIETY, VAGINAL DISCHARGE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, ENDOMETRITIS, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE OF INSERTION (B)(6) 2014 (SUMMONS) AND (B)(6) 2015 (PFS) PATIENT RECEIVED TREATMENT FOR PELVIC/ABDOMINAL, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GEN ABNORMAL. BLEED, PSYCH INJURY, URINARY PROBS. RECEIVED TREATMENT FOR BLEEDING, BLADDER/ URINARY PROBLEM. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 44.3 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. PATHOLOGY TEST - ON AN UNKNOWN DATE: PROLIFERATIVE PHASE ENDOMETRIUM WITH CHRONIC ENDOMETRITIS. FRAGMENTS OF BENIGN ENDOMETRIAL POLYP. FRAGMENTS OF ECTOCERVICAL AND ENDOCERVICAL MUCOSA WITH ACUTE AND CHRONIC CERVICITIS AND REACTIVE EPITHELIAL CHANGES. NO HYPERPLASIA OR MALIGNANCY IDENTIFIED. LOT NUMBER REPORTED ( C69280, D01873 ) IS NOT VALID. LOT NUMBERS: LEFT-C59250, RIGHT-001873. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-JUN-2020: UPDATE OF INFORMATION (BATCH IS NOT VALID). 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 ENDOMETRITIS ('CHRONIC ENDOMETRITIS') AND GENITAL HAEMORRHAGE ('GEN ABNORMAL. BLEED') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C69280, D01873) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ANXIETY AND DYSMENORRHOEA. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY, HYPERMENORRHEA, ANEMIA, UTERINE FIBROID, ENDOMETRIAL POLYP, BURNING MICTURITION, (B)(6) INFECTION, ENDOMETRIAL ABLATION AND D & C. CONCOMITANT PRODUCTS INCLUDED DULOXETINE HYDROCHLORIDE (CYMBALTA) SINCE (B)(6) 2014 FOR ANXIETY, CEFIXIME (FLEXERIL) SINCE (B)(6) 2015 FOR DYSMENORRHEA, PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2015 FOR PELVIC PAIN AS WELL AS BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE (B)(6) 2015, FENTANYL CITRATE (NARCO) SINCE (B)(6) 2015 AND NSAIDS SINCE (B)(6) 2015. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"), 10 MONTHS 9 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING") (SERIOUSNESS CRITERION INTERVENTION REQUIRED), PELVIC PAIN ("PHYSICAL PAIN / PELVIC PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DYSPAREUNIA ("DYSPAREUNIA"), FATIGUE ("FATIGUE"), MOOD SWINGS ("HORMONAL CHANGES, MOOD SWINGS"), VAGINAL INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL)- TYPE: VAGINAL"), MIGRAINE ("MIGRAINES/HEADACHES") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/LOSS (SPECIFY WHICH ONE) WEIGHT GAIN. "). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DEPRESSION ("PSYCH INJURY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS, DEPRESSION"), DYSURIA ("URINARY PROBS"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY") AND BACK PAIN ("LOWER BACK AREA"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DEPRESSION, DYSURIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MOOD SWINGS, VAGINAL INFECTION, MIGRAINE, ANXIETY, VAGINAL DISCHARGE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, ENDOMETRITIS, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE OF INSERTION (B)(6) 2014 (SUMMONS) AND (B)(6) 2015 (PFS). PATIENT RECEIVED TREATMENT FOR PELVIC/ABDOMINAL, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GEN ABNORMAL. BLEED, PSYCH INJURY, URINARY PROBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 44.3 KG/SQM. HYSTEROSALPINGOGRAM ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. PATHOLOGY TEST ON AN UNKNOWN DATE: PROLIFERATIVE PHASE ENDOMETRIUM WITH CHRONIC ENDOMETRITIS. FRAGMENTS OF BENIGN ENDOMETRIAL POLYP. FRAGMENTS OF ECTOCERVICAL AND ENDOCERVICAL MUCOSA WITH ACUTE AND CHRONIC CERVICITIS AND REACTIVE EPITHELIAL CHANGES. NO HYPERPLASIA OR MALIGNANCY IDENTIFIED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-OCT-2019: PFS AND MR RECEIVED. LOT NUMBER RECEIVED. NEW EVENTS: ABNORMAL BLEEDING (VAGINAL), DYSMENORRHEA; DYSPAREUNIA; FATIGUE; HORMONAL CHANGES, MOOD SWINGS; INFECTION VAGINAL, MIGRAINES/HEADACHES; BACK PAIN, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY AND MENTAL ANGUISH; VAGINAL DISCHARGE; WEIGHT GAIN WERE ADDED. PSYCH INJURY UPDATED TO DEPRESSION. NEW REPORTERS AND PLAINTIFFS INFORMATION ADDED. CONCOMITANT CONDITIONS, DRUGS AND HISTORICAL CONDITIONS WERE ADDED. LAB DATA ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1103848 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | C59250 , D01973 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other| R | ACETAMINOPHEN.| ACETAMINOPHEN.| ACETAMINOPHEN.| ACETAMINOPHEN.| ACETAMINOPHEN.| ACETAMINOPHEN.| ACETAMINOPHEN.| CYMBALTA.| CYMBALTA.| CYMBALTA.| CYMBALTA.| CYMBALTA.| CYMBALTA.| CYMBALTA.| FLEXERIL [CEFIXIME]| FLEXERIL [CEFIXIME].| FLEXERIL [CEFIXIME].| FLEXERIL [CEFIXIME].| FLEXERIL [CEFIXIME].| FLEXERIL [CEFIXIME].| FLEXERIL [CEFIXIME].| NARCO| NARCO.| NARCO.| NARCO.| NARCO.| NARCO.| NARCO.| NSAIDS.| NSAIDS.| NSAIDS.| NSAIDS.| NSAIDS.| NSAIDS.| NSAIDS.| WELLBUTRIN.| WELLBUTRIN.| WELLBUTRIN.| WELLBUTRIN.| WELLBUTRIN.| WELLBUTRIN.| WELLBUTRIN. |