ESSURE
Report
- Report Number
- 2951250-2018-04164
- Event Type
- Injury
- Date Received
- September 27, 2018
- Report Date
- July 23, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/PAIN') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863570, BC713764) 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 "SHE DIDN¿T UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED OBESITY, MISSED ABORTION, CRAMP IN LOWER ABDOMEN, DIARRHEA, ENDOMETRIAL THICKENING, ECTOPIC PREGNANCY AND PARATUBAL CYST. CONCURRENT CONDITIONS INCLUDED CARPAL TUNNEL SYNDROME, VITAMIN D DEFICIENCY, FLANK PAIN, NAUSEA, DIZZINESS, KIDNEY STONES, SYNCOPE, PELVIC DISCOMFORT, ADENOMYOSIS, EPIGASTRIC PAIN, ABDOMINAL PAIN AND OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED NSAIDS SINCE (B)(6)2014 FOR CARPAL TUNNEL SYNDROME AS WELL AS OMEPRAZOLE SINCE (B)(6)2017, ONDANSETRON SINCE (B)(6)2017 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6)2012. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH / EMOTIONAL ANGUISH"), 2 MONTHS 1 DAY AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FIBROMYALGIA ("AUTOIMMUNE DISORDER TYPE OF DISORDER:FIBROMYALGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), GASTROOESOPHAGEAL REFLUX DISEASE ("GASTROESOPHAGEAL REFLUX DISEASE") AND GENITAL HAEMORRHAGE ("GENITAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND VAGINAL HAEMORRHAGE HAD RESOLVED, THE FIBROMYALGIA, MENORRHAGIA, DEPRESSION, ANXIETY, WEIGHT INCREASED, GASTROOESOPHAGEAL REFLUX DISEASE AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN AND THE DYSMENORRHOEA WAS RESOLVING. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, FIBROMYALGIA, GASTROOESOPHAGEAL REFLUX DISEASE, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF SUFFERED PHYSICAL PAIN AND EMOTIONAL ANGUISH BECAUSE OF THE ESSURE DEVICE. INSERTION DETAILS, SPECIFY- 5 COILS EXPOSED ON THE RIGHT AND 1 COIL EXPOSED ON THE LEFT. ONSET DATE OF THE EVENTS PELVIC PAIN, DEPRESSION, ANXIETY, DYSMENORRHEA WERE GIVEN AS (B)(6)2012. RECEIVED TREATMENT FOR PAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.7 KG/SQM. LOT NUMBER: 863570 MANUFACTURING DATE: 2011-05 EXPIRATION DATE: 2014-05. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-JUL-2020: PLAINTIFF FACT SHEET RECEIVED. EVENTS " VAGINAL HEMORRHAGE AND MENORRHAGIA¿ OUTCOME WERE UPDATED TO RECOVERING/RESOLVING. 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") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("MENORRHAGIA"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH / EMOTIONAL ANGUISH"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF SUFFERED PHYSICAL PAIN AND EMOTIONAL ANGUISH BECAUSE OF THE ESSURE DEVICE. INCIDENT NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/PAIN') IN A 27-YEAR-OLD 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 "SHE DIDN¿T UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED OBESITY, MISSED ABORTION, CRAMP IN LOWER ABDOMEN, DIARRHEA, ENDOMETRIAL THICKENING, ECTOPIC PREGNANCY AND PARATUBAL CYST. CONCURRENT CONDITIONS INCLUDED CARPAL TUNNEL SYNDROME, VITAMIN D DEFICIENCY, FLANK PAIN, NAUSEA, DIZZINESS, KIDNEY STONES, SYNCOPE, PELVIC DISCOMFORT, ADENOMYOSIS, EPIGASTRIC PAIN AND ABDOMINAL PAIN. CONCOMITANT PRODUCTS INCLUDED NSAIDS SINCE (B)(6) 2012, OMEPRAZOLE SINCE (B)(6) 2017, ONDANSETRON SINCE (B)(6) 2017 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH / EMOTIONAL ANGUISH"), 2 MONTHS 1 DAY AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FIBROMYALGIA ("AUTOIMMUNE DISORDER TYPE OF DISORDER:FIBROMYALGIA"), MENORRHAGIA ("MENORRHAGIA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND GASTROOESOPHAGEAL REFLUX DISEASE ("GASTROESOPHAGEAL REFLUX DISEASE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND DYSMENORRHOEA WAS RESOLVING AND THE FIBROMYALGIA, MENORRHAGIA, DEPRESSION, ANXIETY, WEIGHT INCREASED AND GASTROOESOPHAGEAL REFLUX DISEASE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, FIBROMYALGIA, GASTROOESOPHAGEAL REFLUX DISEASE, MENORRHAGIA, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF SUFFERED PHYSICAL PAIN AND EMOTIONAL ANGUISH BECAUSE OF THE ESSURE DEVICE. INSERTION DETAILS, SPECIFY- 5 COILS EXPOSED ON THE RIGHT AND 1 COIL EXPOSED ON THE LEFT. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD; CONFIRMING- EVENTS WHICH ARE SAME IN PFS & MR.-PELVIC PAIN AND ABNORMAL BLEEDING, GASTROESOPHAGEAL REFLUX DISEASE,VITAMIN D INSUFFICIENCY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-MAY-2019: NEW PFS AND MR RECEIVED-NEW EVENTS -"AUTOIMMUNE DISORDER TYPE OF DISORDER: FIBROMYALGIA, DYSMENORRHEA (CRAMPING), WEIGHT GAIN,SHE DIDN¿T UNDERGO AN ESSURE CONFIRMATION TEST,GASTROESOPHAGEAL REFLUX DISEASE"REMOVAL DATE AND DOB , REPORTERS INFORMATION, CONCOMITANT DRUGS AND CONDITIONS, MEDICAL HISTORY 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/PAIN') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863570, BC713764) 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 "SHE DIDN¿T UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED OBESITY, MISSED ABORTION, CRAMP IN LOWER ABDOMEN, DIARRHEA, ENDOMETRIAL THICKENING, ECTOPIC PREGNANCY AND PARATUBAL CYST. CONCURRENT CONDITIONS INCLUDED CARPAL TUNNEL SYNDROME, VITAMIN D DEFICIENCY, FLANK PAIN, NAUSEA, DIZZINESS, KIDNEY STONES, SYNCOPE, PELVIC DISCOMFORT, ADENOMYOSIS, EPIGASTRIC PAIN, ABDOMINAL PAIN AND OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED NSAIDS SINCE (B)(6)2014 FOR CARPAL TUNNEL SYNDROME AS WELL AS OMEPRAZOLE SINCE (B)(6) 2017, ONDANSETRON SINCE (B)(6) 2017 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH / EMOTIONAL ANGUISH"), 2 MONTHS 1 DAY AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FIBROMYALGIA ("AUTOIMMUNE DISORDER TYPE OF DISORDER:FIBROMYALGIA"), MENORRHAGIA ("MENORRHAGIA"), GASTROOESOPHAGEAL REFLUX DISEASE ("GASTROESOPHAGEAL REFLUX DISEASE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND GENITAL HAEMORRHAGE ("GENITAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND VAGINAL HAEMORRHAGE HAD RESOLVED, THE FIBROMYALGIA, MENORRHAGIA, DEPRESSION, ANXIETY, WEIGHT INCREASED, GASTROOESOPHAGEAL REFLUX DISEASE AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN AND THE DYSMENORRHOEA WAS RESOLVING. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, FIBROMYALGIA, GASTROOESOPHAGEAL REFLUX DISEASE, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF SUFFERED PHYSICAL PAIN AND EMOTIONAL ANGUISH BECAUSE OF THE ESSURE DEVICE. INSERTION DETAILS, SPECIFY- 5 COILS EXPOSED ON THE RIGHT AND 1 COIL EXPOSED ON THE LEFT. ONSET DATE OF THE EVENTS PELVIC PAIN, DEPRESSION, ANXIETY, DYSMENORRHEA WERE GIVEN AS (B)(6) 2012 RECEIVED TREATMENT FOR PAIN DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.7 KG/SQM. LOT NUMBER: 863570, MANUFACTURING DATE: 2011-05, EXPIRATION DATE: 2014-05 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: OUTCOME OF THE EVENT PAIN, BLEEDING UPDATED TO RECOVERED/ RESOLVED. 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/PAIN') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863570) 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 "SHE DIDN¿T UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED OBESITY, MISSED ABORTION, CRAMP IN LOWER ABDOMEN, DIARRHEA, ENDOMETRIAL THICKENING, ECTOPIC PREGNANCY AND PARATUBAL CYST. CONCURRENT CONDITIONS INCLUDED CARPAL TUNNEL SYNDROME, VITAMIN D DEFICIENCY, FLANK PAIN, NAUSEA, DIZZINESS, KIDNEY STONES, SYNCOPE, PELVIC DISCOMFORT, ADENOMYOSIS, EPIGASTRIC PAIN, ABDOMINAL PAIN AND OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED NSAIDS SINCE (B)(6) 2014 FOR CARPAL TUNNEL SYNDROME AS WELL AS OMEPRAZOLE SINCE (B)(6) 2017, ONDANSETRON SINCE (B)(6) 2017 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH / EMOTIONAL ANGUISH"), 2 MONTHS 1 DAY AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FIBROMYALGIA ("AUTOIMMUNE DISORDER TYPE OF DISORDER:FIBROMYALGIA"), MENORRHAGIA ("MENORRHAGIA"), GASTROOESOPHAGEAL REFLUX DISEASE ("GASTROESOPHAGEAL REFLUX DISEASE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND GENITAL HAEMORRHAGE ("GENITAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND DYSMENORRHOEA WAS RESOLVING AND THE FIBROMYALGIA, MENORRHAGIA, DEPRESSION, ANXIETY, WEIGHT INCREASED, GASTROOESOPHAGEAL REFLUX DISEASE, VAGINAL HAEMORRHAGE AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, FIBROMYALGIA, GASTROOESOPHAGEAL REFLUX DISEASE, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF SUFFERED PHYSICAL PAIN AND EMOTIONAL ANGUISH BECAUSE OF THE ESSURE DEVICE. INSERTION DETAILS, SPECIFY- 5 COILS EXPOSED ON THE RIGHT AND 1 COIL EXPOSED ON THE LEFT. ONSET DATE OF THE EVENTS PELVIC PAIN, DEPRESSION, ANXIETY, DYSMENORRHEA WERE GIVEN AS (B)(6) 2012 DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.7 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-APR-2020: PFS RECEIVED- NEW EVENTS ABNORMAL BLEEDING (VAGINAL), GENITAL BLEEDING, WERE ADDED. 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 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/PAIN') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863570) 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 "SHE DIDN¿T UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED OBESITY, MISSED ABORTION, CRAMP IN LOWER ABDOMEN, DIARRHEA, ENDOMETRIAL THICKENING, ECTOPIC PREGNANCY AND PARATUBAL CYST. CONCURRENT CONDITIONS INCLUDED CARPAL TUNNEL SYNDROME, VITAMIN D DEFICIENCY, FLANK PAIN, NAUSEA, DIZZINESS, KIDNEY STONES, SYNCOPE, PELVIC DISCOMFORT, ADENOMYOSIS, EPIGASTRIC PAIN, ABDOMINAL PAIN AND OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED NSAIDS SINCE (B)(6) 2014 FOR CARPAL TUNNEL SYNDROME AS WELL AS OMEPRAZOLE SINCE (B)(6) 2017, ONDANSETRON SINCE (B)(6) 2017 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH / EMOTIONAL ANGUISH"), 2 MONTHS 1 DAY AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FIBROMYALGIA ("AUTOIMMUNE DISORDER TYPE OF DISORDER:FIBROMYALGIA"), MENORRHAGIA ("MENORRHAGIA"), GASTROOESOPHAGEAL REFLUX DISEASE ("GASTROESOPHAGEAL REFLUX DISEASE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND GENITAL HAEMORRHAGE ("GENITAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND DYSMENORRHOEA WAS RESOLVING AND THE FIBROMYALGIA, MENORRHAGIA, DEPRESSION, ANXIETY, WEIGHT INCREASED, GASTROOESOPHAGEAL REFLUX DISEASE, VAGINAL HAEMORRHAGE AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, FIBROMYALGIA, GASTROOESOPHAGEAL REFLUX DISEASE, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF SUFFERED PHYSICAL PAIN AND EMOTIONAL ANGUISH BECAUSE OF THE ESSURE DEVICE. INSERTION DETAILS, SPECIFY- 5 COILS EXPOSED ON THE RIGHT AND 1 COIL EXPOSED ON THE LEFT. ONSET DATE OF THE EVENTS PELVIC PAIN, DEPRESSION, ANXIETY, DYSMENORRHEA WERE GIVEN AS (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.7 KG/SQM. LOT NUMBER: 863570 MANUFACTURING DATE: 2011-05 EXPIRATION DATE: 2014-05. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-MAY-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.
"NTANEOUS" CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("MENORRHAGIA"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH/EMOTIONAL ANGUISH"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF SUFFERED PHYSICAL PAIN AND EMOTIONAL ANGUISH BECAUSE OF THE ESSURE DEVICE. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 754373 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 863570, BC713764 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| NSAIDS| NSAIDS| NSAIDS| NSAIDS| NSAIDS| OMEPRAZOLE| OMEPRAZOLE| OMEPRAZOLE| OMEPRAZOLE| OMEPRAZOLE| ONDANSETRON| ONDANSETRON| ONDANSETRON| ONDANSETRON| ONDANSETRON |