ESSURE
Report
- Report Number
- 2951250-2019-09591
- Event Type
- Injury
- Date Received
- October 7, 2019
- Date of Event
- December 1, 2011
- Report Date
- January 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
- AZ, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DYSPAREUNIA ('DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)'), ENDOMETRIAL ABLATION ('ABLATION') AND ARTHRITIS INFECTIVE ('KNEE SYNOVIAL FLUID') IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871978, 871977) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DYSMENORRHEA, MIGRAINE AND PELVIC PAIN. CONCURRENT CONDITIONS INCLUDED HEAVY PERIODS. CONCOMITANT PRODUCTS INCLUDED DROSPIRENONE + ETHINYLESTRADIOL (YAZ) FROM 2007 TO 2012 FOR BIRTH CONTROL, HEAVY PERIODS AND IRREGULAR PERIODS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2011, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA") AND MEMORY IMPAIRMENT ("EXTREME FORGETFULNESS"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOMETRIAL ABLATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 1 YEAR AFTER INSERTION OF ESSURE. IN (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES") AND ABDOMINAL PAIN ("PAIN ABDOMINAL"). IN (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS") AND RASH PAPULAR ("SMALL RED BUMPS ON SPINE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ARTHRITIS INFECTIVE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED HYPERSENSITIVITY ("HYPERSENSITIVITY."), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), NERVOUS SYSTEM DISORDER ("NUERO CONDIT/PROBLEM"), ALLERGY TO METALS ("NICKEL ALLERGY") AND COGNITIVE DISORDER ("COGNITIVE DYSFUNCTION WAY WORSE"). THE PATIENT WAS TREATED WITH CEFAZOLIN AND SURGERY (ABLATION, HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL) AND SIP KNEE SURGEY, IN FACTION ON (B)(6) 2015). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DYSPAREUNIA AND RASH PAPULAR HAD RESOLVED, THE ENDOMETRIAL ABLATION, ARTHRITIS INFECTIVE, HYPERSENSITIVITY, PSYCHOLOGICAL TRAUMA, VAGINAL DISCHARGE, NERVOUS SYSTEM DISORDER, ALOPECIA, ALLERGY TO METALS, MEMORY IMPAIRMENT AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE DYSMENORRHOEA, MIGRAINE, NAUSEA AND COGNITIVE DISORDER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, ARTHRITIS INFECTIVE, COGNITIVE DISORDER, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIAL ABLATION, HYPERSENSITIVITY, MEMORY IMPAIRMENT, MIGRAINE, NAUSEA, NERVOUS SYSTEM DISORDER, PSYCHOLOGICAL TRAUMA, RASH PAPULAR AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SURGICAL PATHOLOGY FINAL REPORT: CERVIX, NEGATIVE FOR INTRAEPITHELIAL LESION. ENDOMETRIUM WITH SECRETORY PATTERN; NEGATIVE FOR HYPERPLASIA AND NEGATIVE FOR MALIGNANCY. MYOMETRIUM, UNREMARKABLE. BILATERAL FALLOPIAN TUBES WITH RIGHT PARA-TUBAL CYST; OTHERWISE, UNREMARKABLE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. ULTRASOUND SCAN VAGINA - ON (B)(6) 2011: HEAVY MENSES. EVENTS: ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: SEPTIC ARTHRITIS, DYSMENORRHEA AND NICKEL ALLERGY". LOT NUMBER: 871977, MANUFACTURE DATE: 2011-06, EXPIRATION DATE: 2014-06-30. LOT NUMBER: 871978, 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 15-OCT-2019: QUALITY-SAFETY EVALUATION OF PTC. 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 DYSPAREUNIA ('DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE'), ENDOMETRIAL ABLATION ('ABLATION') AND ARTHRITIS INFECTIVE ('KNEE SYNOVIAL FLUID') IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 871978, 871977) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PELVIC PAIN, DEPRESSION, INFLAMMATION, FIBROMYALGIA, NAUSEA, FOGGY FEELING IN HEAD, CONFUSION, NABOTHIAN CYST, NECK PAIN, SEPTIC ARTHRITIS AND HYPOKALEMIA. CONCURRENT CONDITIONS INCLUDED HEAVY PERIODS, POPLITEAL CYST, OSTEOARTHRITIS, THROMBOSIS, DEGENERATIVE DISC DISEASE, DIZZINESS, FATIGUE, UPSET STOMACH, CONSTIPATION, KNEE PAIN, FEVER, CHILLS, JOINT DISORDER, SWELLING NOS, ARTHRITIS, SYNOVITIS, INFECTION, KNEE SWELLING, JOINT INFECTION, LEUKOCYTOSIS, ENDOCARDITIS, CHONDROMALACIA, ADHD, ASTHMA, DEGENERATIVE JOINT DISEASE, GERD, GASTROPARESIS, IRRITABLE BOWEL SYNDROME, POST-TRAUMATIC STRESS DISORDER, TEMPOROMANDIBULAR JOINT DISORDER, PARATUBAL CYST AND ANXIETY. CONCOMITANT PRODUCTS INCLUDED DROSPIRENONE + ETHINYLESTRADIOL (YAZ) FROM 2007 TO 2012 FOR BIRTH CONTROL, HEAVY PERIODS AND IRREGULAR PERIODS AS WELL AS CALCIUM GLYCEROPHOSPHATE;CALCIUM PHOSPHATE;GLUTAMIC ACID;VITAMIN B NOS (CEREBREX), CEFIXIME (FLEXERIL), DIAZEPAM, ETHINYLESTRADIOL;ETONOGESTREL (NUVARING) FROM (B)(6) 2010 TO (B)(6) 2011, LUBIPROSTONE (AMITIZA), TRAMADOL AND VITAMIN D NOS (VITAMIN D) SINCE 2008. IN 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). ON (B)(6) 2011, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA") AND MEMORY IMPAIRMENT ("EXTREME FORGETFULNESS"). ON (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES"). ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOMETRIAL ABLATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 1 YEAR AFTER INSERTION OF ESSURE. ON (B)(6) 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("PAIN ABDOMINAL"). ON (B)(6) 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS") AND RASH PAPULAR ("SMALL RED BUMPS ON SPINE/RASHES UP THE SPINE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ARTHRITIS INFECTIVE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED HYPERSENSITIVITY ("HYPERSENSITIVITY."), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), NERVOUS SYSTEM DISORDER ("NUERO CONDIT/PROBLEM"), COGNITIVE DISORDER ("COGNITIVE DYSFUNCTION WAY WORSE") AND PELVIC PAIN ("PELVIC PAIN"). THE PATIENT WAS TREATED WITH CEFAZOLIN, IBUPROFEN AND SURGERY (ABLATION, HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL) AND SIP KNEE SURGERY, IN FACTION ON (B)(6) 2015). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DYSPAREUNIA, DYSMENORRHOEA, VAGINAL DISCHARGE, ALOPECIA, RASH PAPULAR AND PELVIC PAIN HAD RESOLVED, THE ENDOMETRIAL ABLATION, ARTHRITIS INFECTIVE, HYPERSENSITIVITY, PSYCHOLOGICAL TRAUMA, NERVOUS SYSTEM DISORDER, ALLERGY TO METALS, MEMORY IMPAIRMENT AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE MIGRAINE, NAUSEA AND COGNITIVE DISORDER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, ARTHRITIS INFECTIVE, COGNITIVE DISORDER, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIAL ABLATION, HYPERSENSITIVITY, MEMORY IMPAIRMENT, MIGRAINE, NAUSEA, NERVOUS SYSTEM DISORDER, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, RASH PAPULAR AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SURGICAL PATHOLOGY FINAL REPORT: CERVIX, NEGATIVE FOR INTRAEPITHELIAL LESION. ENDOMETRIUM WITH SECRETORY PATTERN; NEGATIVE FOR HYPERPLASIA AND NEGATIVE FOR MALIGNANCY. MYOMETRIUM, UNREMARKABLE. BILATERAL FALLOPIAN TUBES WITH RIGHT PARA-TUBAL CYST; OTHERWISE, UNREMARKABLE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM: ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. ULTRASOUND SCAN VAGINA: ON (B)(6) 2011: HEAVY MENSES. EVENTS: ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: SEPTIC ARTHRITIS, DYSMENORRHEA AND NICKEL ALLERGY". LOT NUMBER: 871977, MANUFACTURE DATE: 2011-06, EXPIRATION DATE: 2014-06-30. LOT NUMBER: 871978, 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 6-DEC-2019: PFS RECEIVED. NEW EVENT PELVIC PAIN WAS ADDED. EVENT ONSET DATE WAS UPDATED. UPDATED OUTCOME OF EVENT DYSMENORRHEA FROM RECOVERING / RESOLVING TO RECOVERED / RESOLVED, HAIR LOSS, VAGINAL DISCHARGE FROM UNKNOWN TO RECOVERED / RESOLVED. CONCOMITANT DRUGS, TREATMENT DRUG,REPORTER WAS ADDED. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH 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 DYSPAREUNIA ('DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)'), ENDOMETRIAL ABLATION ('ABLATION') AND ARTHRITIS INFECTIVE ('KNEE SYNOVIAL FLUID') IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871978, 871977) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DYSMENORRHEA, MIGRAINE AND PELVIC PAIN. CONCURRENT CONDITIONS INCLUDED HEAVY PERIODS. CONCOMITANT PRODUCTS INCLUDED DROSPIRENONE + ETHINYLESTRADIOL (YAZ) FROM (B)(6) TO (B)(6) FOR BIRTH CONTROL, HEAVY PERIODS AND IRREGULAR PERIODS. IN (B)(6) , THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA") AND MEMORY IMPAIRMENT ("EXTREME FORGETFULNESS"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOMETRIAL ABLATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 1 YEAR AFTER INSERTION OF ESSURE. IN (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES") AND ABDOMINAL PAIN ("PAIN ABDOMINAL"). IN (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN NOVEMBER 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS") AND RASH PAPULAR ("SMALL RED BUMPS ON SPINE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ARTHRITIS INFECTIVE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED HYPERSENSITIVITY ("HYPERSENSITIVITY."), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), NERVOUS SYSTEM DISORDER ("NEURO CONDIT/PROBLEM"), ALLERGY TO METALS ("NICKEL ALLERGY") AND COGNITIVE DISORDER ("COGNITIVE DYSFUNCTION WAY WORSE"). THE PATIENT WAS TREATED WITH CEFAZOLIN AND SURGERY (ABLATION, HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL) AND SIP KNEE SURGERY, IN FACTION ON (B)(6) 2015). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DYSPAREUNIA AND RASH PAPULAR HAD RESOLVED, THE ENDOMETRIAL ABLATION, ARTHRITIS INFECTIVE, HYPERSENSITIVITY, PSYCHOLOGICAL TRAUMA, VAGINAL DISCHARGE, NERVOUS SYSTEM DISORDER, ALOPECIA, ALLERGY TO METALS, MEMORY IMPAIRMENT AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE DYSMENORRHOEA, MIGRAINE, NAUSEA AND COGNITIVE DISORDER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, ARTHRITIS INFECTIVE, COGNITIVE DISORDER, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIAL ABLATION, HYPERSENSITIVITY, MEMORY IMPAIRMENT, MIGRAINE, NAUSEA, NERVOUS SYSTEM DISORDER, PSYCHOLOGICAL TRAUMA, RASH PAPULAR AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SURGICAL PATHOLOGY FINAL REPORT: CERVIX, NEGATIVE FOR INTRAEPITHELIAL LESION. ENDOMETRIUM WITH SECRETORY PATTERN; NEGATIVE FOR HYPERPLASIA AND NEGATIVE FOR MALIGNANCY. MYOMETRIUM, UNREMARKABLE. BILATERAL FALLOPIAN TUBES WITH RIGHT PARA-TUBAL CYST; OTHERWISE, UNREMARKABLE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. ULTRASOUND SCAN VAGINA - ON (B)(6) 2011: HEAVY MENSES. EVENTS: ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: SEPTIC ARTHRITIS, DYSMENORRHEA AND NICKEL ALLERGY". QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-SEP-2019: PLAINTIFF FACT SHEET AND MEDICAL RECORD RECEIVED. PER PFS FOLLOWING EVENTS¿ NICKEL ALLERGY, KNEE SYNOVIAL FLUID, SMALL RED BUMPS ON SPINE, NAUSEA, COGNITIVE DYSFUNCTION WAY WORSE, ABLATION, EXTREME FORGETFULNESS, MIGRAINE/HEADACHE (PREVIOUSLY REPORTED AS MIGRAINE) AND PAIN ABDOMINAL¿ WERE ADDED. REPORTER¿S INFORMATION, DEMOGRAPHICS, MEDICAL HISTORY, HISTORICAL CONDITION AND ESSURE LOT NUMBER WERE ADDED. EVENT" DYSPAREUNIA, DYSMENORRHEA" WAS UPDATED TO RECOVERED/RESOLVED AND "MIGRAINE" TO RECOVERING/RESOLVING. 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 DYSPAREUNIA ('DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)') 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 DYSPAREUNIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), HYPERSENSITIVITY ("HYPERSENSITIVITY."), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), MIGRAINE ("MIGRAINE"), NERVOUS SYSTEM DISORDER ("NUERO CONDIT/PROBLEM") AND ALOPECIA ("HAIR LOSS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DYSPAREUNIA, DYSMENORRHOEA, HYPERSENSITIVITY, PSYCHOLOGICAL TRAUMA, VAGINAL DISCHARGE, MIGRAINE, NERVOUS SYSTEM DISORDER AND ALOPECIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, DYSMENORRHOEA, DYSPAREUNIA, HYPERSENSITIVITY, MIGRAINE, NERVOUS SYSTEM DISORDER, PSYCHOLOGICAL TRAUMA AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2012: ESSURE CONFIRMATION TEST-(UNSPECIFIED) RESULT- BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-SEP-2019: PLAINTIFF FACT SHEET RECEIVED. EVENT INJURY WAS DELETED AND DEVICE CATEGORY CHANGED FROM DEVICE OTHER EVENT TO INCIDENT. EVENTS ADDED FROM PFS- DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), DYSMENORRHEA (CRAMPING)), HYPERSENSITIVITY, PSYCH INJURY, VAGINAL DISCHARGE, MIGRAINE, NUERO CONDIT/PROBLEM, HAIR LOSS. LAB DATA WERE 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 956768 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 871978, 871977 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Other| R | AMITIZA| CEREBREX| DIAZEPAM| FLEXERIL [CEFIXIME]| NUVARING| TRAMADOL| VITAMIN D [VITAMIN D NOS]| YAZ| YAZ| YAZ |