ESSURE
Report
- Report Number
- 2951250-2019-03017
- Event Type
- Injury
- Date Received
- June 24, 2019
- Date of Event
- November 1, 2011
- Report Date
- August 26, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN /PAIN') IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822376) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED NSAIDS, PANTOPRAZOLE AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"), 5 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWING"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES,"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). ON (B)(6) 2015, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED FATIGUE ("FATIGUE,"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, DYSPAREUNIA AND VAGINAL DISCHARGE HAD RESOLVED AND THE WEIGHT INCREASED, MOOD SWINGS, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR PAIN AND ABNORMAL BLEEDING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: RESULT OF ESSURE CONFIRMATION TEST- TOTAL BILATERAL OCCLUSION. IMAGING PROCEDURE - ON (B)(6) 2011: RESULT NOT PROVIDED. ULTRASOUND SCAN - ON (B)(6) 2015: IMPPESSION: 1. NORMAL UTERUS. 2. TWO SMALL INCIDENTAL BENIGN UTERINE LEIOMYOMAS. 3. SIMPLE CYST VERSUS DOMINANT. FOLLICLE RIGHT OVARY MEASURING 9 MM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, DYSMENORRHOEA. LOT NUMBER: 822376 MANUFACTURE DATE: 2011-01 EXPIRATION DATE: 2014-01. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-AUG-2020: QUALITY-SAFETY EVALUATION OF PTC. 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 ('PHYSICAL PAIN /PAIN') IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822376) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED NSAIDS, PANTOPRAZOLE AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"), 5 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWING"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES,"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). ON (B)(6) 2015, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED FATIGUE ("FATIGUE,"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE WEIGHT INCREASED, MOOD SWINGS, MENORRHAGIA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.3 KG/SQM. HYSTEROSALPINGOGRAM - ON 27-AUG-2011: RESULT OF ESSURE CONFIRMATION TEST- TOTAL BILATERAL OCCLUSION. ULTRASOUND SCAN - ON 27-FEB-2015: IMPPESSION: 1. NORMAL UTERUS. 2. TWO SMALL INCIDENTAL BENIGN UTERINE LEIOMYOMAS. 3. SIMPLE CYST VERSUS DOMINANT. FOLLICLE RIGHT OVARY MEASURING 9 MM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, DYSMENORRHOEA. LOT NUMBER: 822376 MANUFACTURE DATE: 2011-01 EXPIRATION DATE: 2014-01 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-JUN-2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT: 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 PELVIC PAIN ('PHYSICAL PAIN /PAIN') IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822376) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED NSAIDS, PANTOPRAZOLE AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"), 5 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWING"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES,"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). ON (B)(6) 2015, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED FATIGUE ("FATIGUE,"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, DYSPAREUNIA AND VAGINAL DISCHARGE HAD RESOLVED AND THE WEIGHT INCREASED, MOOD SWINGS, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR PAIN AND ABNORMAL BLEEDING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: RESULT OF ESSURE CONFIRMATION TEST- TOTAL BILATERAL OCCLUSION. IMAGING PROCEDURE - ON (B)(6) 2011: RESULT NOT PROVIDED. ULTRASOUND SCAN - ON (B)(6) 2015: IMPPESSION: 1. NORMAL UTERUS. 2. TWO SMALL INCIDENTAL BENIGN UTERINE LEIOMYOMAS. 3. SIMPLE CYST VERSUS DOMINANT. FOLLICLE RIGHT OVARY MEASURING 9 MM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, DYSMENORRHOEA. LOT NUMBER: 822376 MANUFACTURE DATE: 2011-01 EXPIRATION DATE: 2014-01. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PFS RECEIVED. OUTCOME OF EVENTS "PELVIC PAIN, MENORRHAGIA, ABNORMAL BLEEDING, APAREUNIA, DYSMENORRHEA, DYSPAREUNIA, VAGINAL DISCHARGE WAS CHANGED TO RECOVERED/ RESOLVED". LAB DATA ESSURE CONFIRMATION TEST AND REPORTER CAUSALITY COMMENT WAS UPDATED. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN /PAIN') IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822376) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED NSAIDS, PANTOPRAZOLE AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"), 5 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWING"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES,"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). ON (B)(6) 2015, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED FATIGUE ("FATIGUE,"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, DYSPAREUNIA AND VAGINAL DISCHARGE HAD RESOLVED AND THE WEIGHT INCREASED, MOOD SWINGS, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR PAIN AND ABNORMAL BLEEDING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: RESULT OF ESSURE CONFIRMATION TEST- TOTAL BILATERAL OCCLUSION. IMAGING PROCEDURE - ON (B)(6) 2011: RESULT NOT PROVIDED. ULTRASOUND SCAN - ON (B)(6) 2015: IMPRESSION: NORMAL UTERUS. TWO SMALL INCIDENTAL BENIGN UTERINE LEIOMYOMAS. SIMPLE CYST VERSUS DOMINANT. FOLLICLE RIGHT OVARY MEASURING 9 MM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, DYSMENORRHOEA. LOT NUMBER: 822376, MANUFACTURE DATE: 2011-01, EXPIRATION DATE: 2014-01. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PFS RECEIVED. OUTCOME OF EVENTS "PELVIC PAIN, MENORRHAGIA, ABNORMAL BLEEDING, APAREUNIA, DYSMENORRHEA, DYSPAREUNIA, VAGINAL DISCHARGE WAS CHANGED TO RECOVERED/ RESOLVED". LAB DATA ESSURE CONFIRMATION TEST AND REPORTER CAUSALITY COMMENT WAS UPDATED. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN /PAIN') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822376) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED NSAIDS, PANTOPRAZOLE AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"), 5 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWING"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES,"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). ON (B)(6) 2015, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED FATIGUE ("FATIGUE,"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE WEIGHT INCREASED, MOOD SWINGS, MENORRHAGIA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: RESULT OF ESSURE CONFIRMATION TEST- TOTAL BILATERAL OCCLUSION. ULTRASOUND SCAN - ON (B)(6) 2015: IMPRESSION: NORMAL UTERUS. TWO SMALL INCIDENTAL BENIGN UTERINE LEIOMYOMAS. SIMPLE CYST VERSUS DOMINANT. FOLLICLE RIGHT OVARY MEASURING 9 MM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, DYSMENORRHOEA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-JUN-2019: PFS AND MR RECEIVED : AKA NAME ADDED, REPORTER ADDED, LOT NUMBER ADDED, PATIENT DEMOGRAPHIC ADDED, ESSURE REMOVAL DATE ADDED, PRODUCT INDICATION UPDATED. EVENTS ADDED- MOOD SWING, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), APAREUNIA, DEPRESSION, MENTAL ANGUISH, MIGRAINES, HEADACHES, DYSMENORRHEA (CRAMPING), DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE), VAGINAL DISCHARGE, FATIGUE, WEIGHT GAIN. EVENTS OUTCOME UPDATED. EVENTS ONSET DATE, EVENTS SEVERITY , CONCOMITANT DRUG AND LAB DATA ADDED. INCIDENT: 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 |
|---|---|---|---|---|---|---|---|
| 519607 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822376 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| NSAIDS| NSAIDS| NSAIDS| NSAIDS| NSAIDS| PANTOPRAZOLE| PANTOPRAZOLE| PANTOPRAZOLE| PANTOPRAZOLE| PANTOPRAZOLE| ACETAMINOPHEN| NSAIDS| PANTOPRAZOLE |