ESSURE
Report
- Report Number
- 2951250-2017-03640
- Event Type
- Injury
- Date Received
- September 14, 2017
- Date of Event
- September 1, 2012
- Report Date
- April 8, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN / PAIN") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955816 NOT VALID) 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 "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIPAROUS. CONCURRENT CONDITIONS INCLUDED LOWER ABDOMINAL PAIN, YEAST INFECTION, VAGINAL DISCHARGE AND VAGINAL ITCHING. CONCOMITANT PRODUCTS INCLUDED NSAID'S FOR VAGINAL BLEEDING AND MENORRHAGIA. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2012, 4 MONTHS 28 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:MENTAL ANGUISH") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION"). IN (B)(6)2012, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA, ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN) AND SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6)2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING, THE MENORRHAGIA HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA - ON AN UNKNOWN DATE: 3.7 CM LEFT OVARIAN CYST ENDOMETRIAL BIOPSY SHOWED DISORDERED PROLIFERATIVE PHASE. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-AUG-2018: PLAINTIFF FACT SHEET WAS RECEIVED EVENTS ADDED FROM PFS- DEPRESSION AND MENTAL ANGUISH. EVENTS ONSET DATE WERE UPDATED. INCIDENT: NO VALID 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") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955816 NOT VALID) 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 "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIPAROUS. * ENDOMETRIAL BIOPSY SHOWED DISORDERED PROLIFERATIVE PHASE. CONCURRENT CONDITIONS INCLUDED LOWER ABDOMINAL PAIN, YEAST INFECTION, VAGINAL DISCHARGE, VAGINAL ITCHING, AUDITORY DISORDER SINCE JUNE 2016 AND FIBROMYALGIA SINCE (B)(6) 2016. CONCOMITANT PRODUCTS INCLUDED NSAID'S FOR VAGINAL BLEEDING AND MENORRHAGIA AS WELL AS MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND PREGABALIN (LYRICA). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA, ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), 4 MONTHS 28 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:MENTAL ANGUISH") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN) AND SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA AND ABDOMINAL PAIN HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, ANXIETY, DEPRESSION AND VAGINAL INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATES OF REMOVAL DISCREPANT (B)(6) 2018. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA - ON AN UNKNOWN DATE: RESULTS: 3.7 CM LEFT OVARIAN CYST. DIAGNOSTIC RESULTS: ENDOMETRIAL BIOPSY SHOWED DISORDERED PROLIFERATIVE PHASE. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-NOV-2018: PFS RECEIVED: NEW EVENTS INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL, ABDOMINAL PAIN, HEAVY BLEEDING WERE ADDED. EVENT OUTCOME UPDATED FROM RECOVERING / RESOLVING TO RECOVERED / RESOLVED FOR PELVIC PAIN. MEDICAL HISTORY AND CONCOMITANT DRUGS WERE ADDED. INCIDENT: NO VALID 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN / PAIN") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955816 INVALID) 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 "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIPAROUS. CONCURRENT CONDITIONS INCLUDED LOWER ABDOMINAL PAIN, YEAST INFECTION, VAGINAL DISCHARGE AND VAGINAL ITCHING. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, 4 MONTHS 27 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA, ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN) AND SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING, THE MENORRHAGIA HAD RESOLVED AND THE VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA - ON AN UNKNOWN DATE: 3.7 CM LEFT OVARIAN CYST ENDOMETRIAL BIOPSY SHOWED DISORDERED PROLIFERATIVE PHASE. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: MENORRHAGIA MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-JUL-2018: QUALITY DEPARTMENT CONFIRMED LOT NUMBER IS INVALID - NO UPDATE OF PTC INVESTIGATION WILL BE PERFORMED. INCIDENT NO VALID 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") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955816) 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 "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIPAROUS. CONCURRENT CONDITIONS INCLUDED LOWER ABDOMINAL PAIN, YEAST INFECTION, VAGINAL DISCHARGE AND VAGINAL ITCHING. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, 4 MONTHS 27 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA, ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY). ESSURE WAS REMOVED ON 20-FEB-2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN AND THE MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA - ON AN UNKNOWN DATE: 3.7 CM LEFT OVARIAN CYST ENDOMETRIAL BIOPSY SHOWED DISORDERED PROLIFERATIVE PHASE. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-MAR-2018: PFS AND MR RECEIVED: NEW REPORTERS, PATIENT DEMOGRAPHIC INFORMATION, PRODUCT INDICATION UPDATED, LOT NO, TREATMENT MEDICATIONS, NEW EVENTS VAGINAL HAEMORRHAGE AND DEVICE MONITORING PROCEDURE NOT PERFORMED ADDED. OUTCOME OF THE EVENT "MENORRHAGIA" WAS UPDATED. INCIDENT AT THE TIME OF REPORTING, 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") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955816) 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 "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIPAROUS. CONCURRENT CONDITIONS INCLUDED LOWER ABDOMINAL PAIN, YEAST INFECTION, VAGINAL DISCHARGE AND VAGINAL ITCHING. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, 4 MONTHS 27 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA, ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN) AND SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING, THE MENORRHAGIA HAD RESOLVED AND THE VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA - ON AN UNKNOWN DATE: 3.7 CM LEFT OVARIAN CYST ENDOMETRIAL BIOPSY SHOWED DISORDERED PROLIFERATIVE PHASE. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-MAY-2018: PFS RECEIVED. OUTCOME OF THE EVENT PELVIC PAIN UPDATED TO RECOVERING/RESOLVING. TREATMENT DRUG ADDED. INCIDENT: AT THE TIME OF REPORTING, 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 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955816 NOT VALID) 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 "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIPAROUS. ENDOMETRIAL BIOPSY SHOWED DISORDERED PROLIFERATIVE PHASE. CONCURRENT CONDITIONS INCLUDED AUDITORY DISORDER SINCE (B)(6) 2016, FIBROMYALGIA SINCE (B)(6) 2016, LOWER ABDOMINAL PAIN, YEAST INFECTION, VAGINAL DISCHARGE AND VAGINAL ITCHING. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2012 TO (B)(6) 2012 FOR CONTRACEPTION, NSAIDS FOR VAGINAL BLEEDING AND MENORRHAGIA AS WELL AS PREGABALIN (LYRICA). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA, ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), 4 MONTHS 28 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:MENTAL ANGUISH") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("HEAVY BLEEDING") AND VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN) AND SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE AND ABDOMINAL PAIN HAD RESOLVED AND THE ANXIETY, DEPRESSION AND VAGINAL INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATES OF REMOVAL DISCREPANT (B)(6) 2013, (B)(6) 2018 PATIENT RECEIVED TREATMENT FOR EVENTS ¿ PELVIC PAIN , ABNORMAL BLEEDING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA - ON AN UNKNOWN DATE: RESULTS: 3.7 CM LEFT OVARIAN CYST. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: MENORRHAGIA. 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 VAGINAL BLEEDING UPDATED TO RECOVERED / RESOLVED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION 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 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955816 NOT VALID) 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 "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIPAROUS. ENDOMETRIAL BIOPSY SHOWED DISORDERED PROLIFERATIVE PHASE. CONCURRENT CONDITIONS INCLUDED AUDITORY DISORDER SINCE (B)(6) 2016, FIBROMYALGIA SINCE (B)(6) 2016, LOWER ABDOMINAL PAIN, YEAST INFECTION, VAGINAL DISCHARGE AND VAGINAL ITCHING. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2012 TO (B)(6) 2012 FOR CONTRACEPTION, NSAIDS FOR VAGINAL BLEEDING AND MENORRHAGIA AS WELL AS PREGABALIN (LYRICA). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA, ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), 4 MONTHS 28 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:MENTAL ANGUISH") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("HEAVY BLEEDING") AND VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN) AND SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE AND ABDOMINAL PAIN HAD RESOLVED AND THE ANXIETY, DEPRESSION AND VAGINAL INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATES OF REMOVAL DISCREPANT (B)(6) 2013, (B)(6) 2018 PATIENT RECEIVED TREATMENT FOR EVENTS ¿ PELVIC PAIN , ABNORMAL BLEEDING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA - ON AN UNKNOWN DATE: RESULTS: 3.7 CM LEFT OVARIAN CYST. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: MENORRHAGIA. LOT NUMBER ( 955816 ) IS INVALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-JUN-2020: QUALITY-SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION 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 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955816-NOT VALID,955616) 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 "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIPAROUS, RIGHT LOWER QUADRANT PAIN, OVARIAN CYST, NAUSEA AND BACK PAIN. ENDOMETRIAL BIOPSY SHOWED DISORDERED PROLIFERATIVE PHASE. CONCURRENT CONDITIONS INCLUDED AUDITORY DISORDER SINCE (B)(6) 2016, FIBROMYALGIA SINCE (B)(6) 2016, LOWER ABDOMINAL PAIN, YEAST INFECTION, VAGINAL DISCHARGE AND VAGINAL ITCHING. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2012 TO (B)(6) 2012 FOR CONTRACEPTION, NSAIDS FOR VAGINAL BLEEDING AND MENORRHAGIA AS WELL AS PREGABALIN (LYRICA). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA, ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), 4 MONTHS 28 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:MENTAL ANGUISH") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("HEAVY BLEEDING") AND VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN) AND SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE AND ABDOMINAL PAIN HAD RESOLVED AND THE ANXIETY, DEPRESSION AND VAGINAL INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: DATES OF REMOVAL: (B)(6) 2013 AND (B)(6) 2018 PATIENT RECEIVED TREATMENT FOR EVENTS ¿ PELVIC PAIN , ABNORMAL BLEEDING TRAILING COILS FIVE ON LEFT AND FIVE ON RIGHT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA - ON AN UNKNOWN DATE: RESULTS: 3.7 CM LEFT OVARIAN CYST. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD ; MENORRHAGIA, ABDOMINAL PAIN, PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-APR-2021: 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 / PAIN') IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955816-NOT VALID,955616) 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 "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIPAROUS, RIGHT LOWER QUADRANT PAIN, OVARIAN CYST, NAUSEA AND BACK PAIN. ENDOMETRIAL BIOPSY SHOWED DISORDERED PROLIFERATIVE PHASE. CONCURRENT CONDITIONS INCLUDED AUDITORY DISORDER SINCE (B)(6) 2016, FIBROMYALGIA SINCE (B)(6)2016, LOWER ABDOMINAL PAIN, YEAST INFECTION, VAGINAL DISCHARGE AND VAGINAL ITCHING. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6)2012 TO (B)(6) 2012 FOR CONTRACEPTION, NSAIDS FOR VAGINAL BLEEDING AND MENORRHAGIA AS WELL AS PREGABALIN (LYRICA). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA, ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), 4 MONTHS 28 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:MENTAL ANGUISH") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("HEAVY BLEEDING") AND VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN) AND SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE AND ABDOMINAL PAIN HAD RESOLVED AND THE ANXIETY, DEPRESSION AND VAGINAL INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: DATES OF REMOVAL: (B)(6) 2013, (B)(6) 2018 PATIENT RECEIVED TREATMENT FOR EVENTS ¿ PELVIC PAIN , ABNORMAL BLEEDING TRAILING COILS FIVE ON LEFT AND FIVE ON RIGHT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA - ON AN UNKNOWN DATE: RESULTS: 3.7 CM LEFT OVARIAN CYST. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD ; MENORRHAGIA, ABDOMINAL PAIN, PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-MAR-2021: MEDICAL RECORD RECEIVED. REPORTER INFORMATION AND MEDICAL HISTORY ADDED. LOT NUMBER 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") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. 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) AND MENORRHAGIA ("MENORRHAGIA"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY). AT THE TIME OF THE REPORT, THE PELVIC PAIN AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. 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 |
|---|---|---|---|---|---|---|---|
| 645605 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 955816-NOT VALID,955616 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Other| R | DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| LYRICA| LYRICA| LYRICA| LYRICA| LYRICA| LYRICA| NSAID'S| NSAID'S| NSAID'S| NSAIDS| NSAIDS| NSAIDS| NSAIDS |