ESSURE
Report
- Report Number
- 2951250-2017-02715
- Event Type
- Injury
- Date Received
- August 3, 2017
- Date of Event
- July 9, 2015
- Report Date
- September 2, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- 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 DEVICE EXPULSION ("MIGRATION OF THE DEVICE/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT ESSURE IN UTERINE SIDE,"), EMBEDDED DEVICE ("DEVICE EMBEDDED TO HER UTERUS/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT ESSURE IN UTERINE SIDE") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431, 857599) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "WIDENED LEFT ESSURE DEVICE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DIDN¿T UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ANTIPHOSPHOLIPID SYNDROME, ATYPICAL HYPERPLASIA OF ENDOMETRIUM AND BENIGN POLYP OF UTERUS. CONCOMITANT PRODUCTS INCLUDED CETIRIZINE HYDROCHLORIDE (ZYRTEC) SINCE 2000, CITALOPRAM HYDROBROMIDE (CELEXA) SINCE 2007, PARACETAMOL (ACETAMINOPHEN) SINCE 2011 AND RIVAROXABAN (XARELTO) SINCE 2013. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN FEBRUARY 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("SEVERE PELVIC PAIN/ PELVIC PAIN"), ALLERGY TO METALS ("AN ALLERGIC REACTION TO THE NICKEL IN THE DEVICE/ NICKEL ALLERGY"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). ON (B)(6) 2015, 3 YEARS 7 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND PAIN IN EXTREMITY ("LEG PAIN"). THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC LAPAROSCOPY REMOVAL OF WIDENED LEFT ESSURE DEVICE) AND SURGERY (DIAGNOSTIC LAPAROSCOPY REMOVAL OF WIDENED LEFT ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, EMBEDDED DEVICE, ALLERGY TO METALS, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, FATIGUE AND PAIN IN EXTREMITY OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, PELVIC PAIN AND DYSMENORRHOEA HAD RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS, ANXIETY, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PAIN IN EXTREMITY, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS PLACED ON THE PATIENT'S LEFT SIDE. THIS WAS DONE WITHOUT DIFFICULTY FOR 3 COILS INTO TILE ENDOMETRIAL CAVITY, THEN ON THE PATIENT'S LEFT SIDE. THERE WAS SOME MALFUNCTION OF TILE DEVICE WHEN NEW DEVICE WAS USED , AND PHYSICIAN WAS ABLE TO PLACE THIS WITHOUT DIFFICULTY WITH 1 COIL SHOWING THROUGH THE ENDOMETRIAL CAVITY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ALLERGY TO METALS , PELVIC PAIN, ANXIETY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS AND MR RECEIVED- NEW EVENT ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), DEPRESSION, MENTAL ANGUISH, MIGRAINES, HEADACHES,WIDENED LEFT ESSURE DEVICE, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FATIGUE, LEG PAIN, HEAVY BLEEDING, PATIENT DIDN¿T UNDERGO ESSURE CONFIRMATION TEST WERE ADDED. MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT ESSURE IN UTERINE SIDE IS CLUBBED WITH UTERINE PERFORATION AND DEVICE EXPULSION. LOT NUMBER, NEW REPORTERS, PATIENT INFORMATION, CONCOMITANT DRUGS AND CONDITIONS WERE 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 DEVICE EXPULSION ("MIGRATION OF THE DEVICE/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT ESSURE IN UTERINE SIDE,"), EMBEDDED DEVICE ("DEVICE EMBEDDED TO HER UTERUS/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT ESSURE IN UTERINE SIDE") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431, 857599) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "WIDENED LEFT ESSURE DEVICE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DIDN¿T UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ANTIPHOSPHOLIPID SYNDROME, ATYPICAL HYPERPLASIA OF ENDOMETRIUM AND BENIGN POLYP OF UTERUS. CONCOMITANT PRODUCTS INCLUDED CETIRIZINE HYDROCHLORIDE (ZYRTEC) SINCE 2000, CITALOPRAM HYDROBROMIDE (CELEXA) SINCE 2007, PARACETAMOL (ACETAMINOPHEN) SINCE 2011 AND RIVAROXABAN (XARELTO) SINCE 2013. ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("SEVERE PELVIC PAIN/ PELVIC PAIN"), ALLERGY TO METALS ("AN ALLERGIC REACTION TO THE NICKEL IN THE DEVICE/ NICKEL ALLERGY"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). ON (B)(6) 2015, 3 YEARS 7 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND PAIN IN EXTREMITY ("LEG PAIN"). THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC LAPAROSCOPY REMOVAL OF WIDENED LEFT ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, EMBEDDED DEVICE, ALLERGY TO METALS, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, FATIGUE AND PAIN IN EXTREMITY OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, PELVIC PAIN AND DYSMENORRHOEA HAD RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS, ANXIETY, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PAIN IN EXTREMITY, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS PLACED ON THE PATIENT'S LEFT SIDE. THIS WAS DONE WITHOUT DIFFICULTY FOR 3 COILS INTO TILE ENDOMETRIAL CAVITY, THEN ON THE PATIENT'S LEFT SIDE. THERE WAS SOME MALFUNCTION OF TILE DEVICE WHEN NEW DEVICE WAS USED , AND PHYSICIAN WAS ABLE TO PLACE THIS WITHOUT DIFFICULTY WITH 1 COIL SHOWING THROUGH THE ENDOMETRIAL CAVITY. THERE IS AN INCONSISTENCY. ALTHOUGH PFS STATED THAT PLAINTIFF HAD A DIAGNOSTIC LAPAROSCOPY, REMOVAL OF WIDENED LEFT ESSURE DEVICE, THE SURGICAL PATHOLOGY REPORT STATED BILATERAL ESSURES, REMOVAL: SYNTHETIC HARDWARE CONSISTENT WITH ESSURE COILS IDENTIFIED (GROSS EXAMINATION). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ALLERGY TO METALS , PELVIC PAIN, ANXIETY LOT NUMBER: 857599 MANUFACTURE DATE: (B)(6) 2011. EXPIRATION DATE: 2014-05. LOT NUMBER 880431: MANUFACTURE DATE: (B)(6) 2011. EXPIRATION DATE: 2014-07. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL PROBLEM UPDATE. 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ("MIGRATION OF THE DEVICE/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT ESSURE IN UTERINE SIDE,"), EMBEDDED DEVICE ("DEVICE EMBEDDED TO HER UTERUS/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT ESSURE IN UTERINE SIDE") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431, 857599) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "WIDENED LEFT ESSURE DEVICE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DIDN¿T UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: YAZ. CONCURRENT CONDITIONS INCLUDED ANTIPHOSPHOLIPID SYNDROME, ATYPICAL HYPERPLASIA OF ENDOMETRIUM AND BENIGN POLYP OF UTERUS. CONCOMITANT PRODUCTS INCLUDED CETIRIZINE HYDROCHLORIDE (ZYRTEC) SINCE 2000, CITALOPRAM, CITALOPRAM HYDROBROMIDE (CELEXA) SINCE 2007, PARACETAMOL (ACETAMINOPHEN) SINCE 2011 AND RIVAROXABAN (XARELTO) SINCE 2013. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 2 MONTHS 12 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN ("SEVERE PELVIC PAIN/ PELVIC PAIN"), ALLERGY TO METALS ("AN ALLERGIC REACTION TO THE NICKEL IN THE DEVICE/ NICKEL ALLERGY"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND FATIGUE ("FATIGUE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PAIN IN EXTREMITY ("LEG PAIN") AND BACK PAIN ("LOWER BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC LAPAROSCOPY REMOVAL OF WIDENED LEFT ESSURE DEVICE) AND SURGERY (DIAGNOSTIC LAPAROSCOPY REMOVAL OF WIDENED LEFT ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, EMBEDDED DEVICE, ALLERGY TO METALS, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, FATIGUE, PAIN IN EXTREMITY AND BACK PAIN OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, PELVIC PAIN AND DYSMENORRHOEA HAD RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS, ANXIETY, BACK PAIN, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PAIN IN EXTREMITY, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS PLACED ON THE PATIENT'S LEFT SIDE. THIS WAS DONE WITHOUT DIFFICULTY FOR 3 COILS INTO TILE ENDOMETRIAL CAVITY, THEN ON THE PATIENT'S LEFT SIDE. THERE WAS SOME MALFUNCTION OF TILE DEVICE WHEN NEW DEVICE WAS USED , AND PHYSICIAN WAS ABLE TO PLACE THIS WITHOUT DIFFICULTY WITH 1 COIL SHOWING THROUGH THE ENDOMETRIAL CAVITY. THERE IS AN INCONSISTENCY. ALTHOUGH PFS STATED THAT PLAINTIFF HAD A DIAGNOSTIC LAPAROSCOPY, REMOVAL OF WIDENED LEFT ESSURE DEVICE, THE SURGICAL PATHOLOGY REPORT STATED BILATERAL ESSURES, REMOVAL: SYNTHETIC HARDWARE CONSISTENT WITH ESSURE COILS IDENTIFIED (GROSS EXAMINATION). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ALLERGY TO METALS , PELVIC PAIN, ANXIETY LOT NUMBER: 857599 MANUFACTURE DATE: 2011-05 EXPIRATION DATE: 2014-05. LOT NUMBER 880431: MANUFACTURE DATE: 2011-07 EXPIRATION DATE: 2014-07. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-SEP-2018: PFS RECEIVED EVENT " LOWER BACK PAIN" ADDED. ONSET DATE ADDED. CONCOMITANT AND HISTORICAL 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 DEVICE EXPULSION ('MIGRATION OF THE DEVICE/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT ESSURE IN UTERINE SIDE,') AND EMBEDDED DEVICE ('DEVICE EMBEDDED TO HER UTERUS/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT ESSURE IN UTERINE SIDE') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431,857599) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "WIDENED LEFT ESSURE DEVICE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DIDN¿T UNDERGO ESSURE CONFIRMATION TEST". MEDICAL CONDITIONS: (B)(6) 2015: SURGICAL PATHOLOGY REPORT: BILATERAL ESSURES, REMOVAL: SYNTHETIC HARDWARE CONSISTENT WITH ESSURE COILS IDENTIFIED (GROSS EXAMINATION). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: YAZ. CONCURRENT CONDITIONS INCLUDED ANTIPHOSPHOLIPID SYNDROME, ATYPICAL HYPERPLASIA OF ENDOMETRIUM AND BENIGN POLYP OF UTERUS. CONCOMITANT PRODUCTS INCLUDED SINCE 2007, CETIRIZINE HYDROCHLORIDE SINCE 2000, CITALOPRAM, PARACETAMOL (ACETAMINOPHEN) SINCE 2011 AND RIVAROXABAN (XARELTO) SINCE 2013. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("SEVERE PELVIC PAIN/ PELVIC PAIN"), ALLERGY TO METALS ("AN ALLERGIC REACTION TO THE NICKEL IN THE DEVICE/ NICKEL ALLERGY"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), 2 MONTHS 12 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND FATIGUE ("FATIGUE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), PAIN IN EXTREMITY ("LEG PAIN") AND BACK PAIN ("LOWER BACK PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC LAPAROSCOPY REMOVAL OF WIDENED LEFT ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, EMBEDDED DEVICE, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE AND FATIGUE OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, PELVIC PAIN, ALLERGY TO METALS, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, PAIN IN EXTREMITY, BACK PAIN AND WEIGHT INCREASED HAD RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS, ANXIETY, BACK PAIN, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PAIN IN EXTREMITY, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS PLACED ON THE PATIENT'S LEFT SIDE. THIS WAS DONE WITHOUT DIFFICULTY FOR 3 COILS INTO TILE ENDOMETRIAL CAVITY, THEN ON THE PATIENT'S LEFT SIDE. THERE WAS SOME MALFUNCTION OF TILE DEVICE WHEN NEW DEVICE WAS USED , AND PHYSICIAN WAS ABLE TO PLACE THIS WITHOUT DIFFICULTY WITH 1 COIL SHOWING THROUGH THE ENDOMETRIAL CAVITY. THERE IS AN INCONSISTENCY. ALTHOUGH PFS STATED THAT PLAINTIFF HAD A DIAGNOSTIC LAPAROSCOPY, REMOVAL OF WIDENED LEFT ESSURE DEVICE, THE SURGICAL PATHOLOGY REPORT STATED BILATERAL ESSURES, REMOVAL: SYNTHETIC HARDWARE CONSISTENT WITH ESSURE COILS IDENTIFIED (GROSS EXAMINATION). PLAINTIFF REVIVED TREATMENT FOR PAIN, , ALLERGIC REACTION, MIGRATION, OTHER INJURY ,SYMPTOM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-AUG-2020: EXTENSION OF EXPECTED DATE OF NEXT REPORT. 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 DEVICE EXPULSION ('MIGRATION OF THE DEVICE/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT ESSURE IN UTERINE SIDE,') AND EMBEDDED DEVICE ('DEVICE EMBEDDED TO HER UTERUS/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT ESSURE IN UTERINE SIDE') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431,857599) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "WIDENED LEFT ESSURE DEVICE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DIDN¿T UNDERGO ESSURE CONFIRMATION TEST". MEDICAL CONDITIONS: (B)(6) 2015: SURGICAL PATHOLOGY REPORT: BILATERAL ESSURES, REMOVAL: SYNTHETIC HARDWARE CONSISTENT WITH ESSURE COILS IDENTIFIED (GROSS EXAMINATION). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: YAZ. CONCURRENT CONDITIONS INCLUDED ANTIPHOSPHOLIPID SYNDROME, ATYPICAL HYPERPLASIA OF ENDOMETRIUM AND BENIGN POLYP OF UTERUS. CONCOMITANT PRODUCTS INCLUDED SINCE 2007, CETIRIZINE HYDROCHLORIDE SINCE 2000, CITALOPRAM, PARACETAMOL (ACETAMINOPHEN) SINCE 2011 AND RIVAROXABAN (XARELTO) SINCE 2013. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("SEVERE PELVIC PAIN/ PELVIC PAIN"), ALLERGY TO METALS ("AN ALLERGIC REACTION TO THE NICKEL IN THE DEVICE/ NICKEL ALLERGY"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), 2 MONTHS 12 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND FATIGUE ("FATIGUE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), PAIN IN EXTREMITY ("LEG PAIN") AND BACK PAIN ("LOWER BACK PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC LAPAROSCOPY REMOVAL OF WIDENED LEFT ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, EMBEDDED DEVICE, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE AND FATIGUE OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, PELVIC PAIN, ALLERGY TO METALS, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, PAIN IN EXTREMITY, BACK PAIN AND WEIGHT INCREASED HAD RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS, ANXIETY, BACK PAIN, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PAIN IN EXTREMITY, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS PLACED ON THE PATIENT'S LEFT SIDE. THIS WAS DONE WITHOUT DIFFICULTY FOR 3 COILS INTO TILE ENDOMETRIAL CAVITY, THEN ON THE PATIENT'S LEFT SIDE. THERE WAS SOME MALFUNCTION OF TILE DEVICE WHEN NEW DEVICE WAS USED , AND PHYSICIAN WAS ABLE TO PLACE THIS WITHOUT DIFFICULTY WITH 1 COIL SHOWING THROUGH THE ENDOMETRIAL CAVITY. THERE IS AN INCONSISTENCY. ALTHOUGH PFS STATED THAT PLAINTIFF HAD A DIAGNOSTIC LAPAROSCOPY, REMOVAL OF WIDENED LEFT ESSURE DEVICE, THE SURGICAL PATHOLOGY REPORT STATED BILATERAL ESSURES, REMOVAL: SYNTHETIC HARDWARE CONSISTENT WITH ESSURE COILS IDENTIFIED (GROSS EXAMINATION). PLAINTIFF REVIVED TREATMENT FOR PAIN, , ALLERGIC REACTION, MIGRATION, OTHER INJURY ,SYMPTOM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED : OUTCOME OF THE EVENTS PERTAINING TO PAIN, BLEEDING, ALLERGIC REACTION AND WEIGHT GAIN UPDATED TO RECOVERED/RESOLVED. RCC ADDED. 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 DEVICE EXPULSION ('MIGRATION OF THE DEVICE/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT ESSURE IN UTERINE SIDE') AND EMBEDDED DEVICE ('DEVICE EMBEDDED TO HER UTERUS/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT ESSURE IN UTERINE SIDE'). IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431,857599), INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "WIDENED LEFT ESSURE DEVICE". AND DEVICE MONITORING PROCEDURE NOT PERFORMED, "PATIENT DIDN¿T UNDERGO ESSURE CONFIRMATION TEST". MEDICAL CONDITIONS: ON (B)(6) 2015, SURGICAL PATHOLOGY REPORT: BILATERAL ESSURES, REMOVAL. SYNTHETIC HARDWARE CONSISTENT WITH ESSURE COILS IDENTIFIED (GROSS EXAMINATION). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED, FOR AN UNREPORTED INDICATION: YAZ. CONCURRENT CONDITIONS INCLUDED: ANTIPHOSPHOLIPID SYNDROME, ATYPICAL HYPERPLASIA OF ENDOMETRIUM AND BENIGN POLYP OF UTERUS. CONCOMITANT PRODUCTS INCLUDED: SINCE 2007, CETIRIZINE HYDROCHLORIDE SINCE 2000, CITALOPRAM, PARACETAMOL (ACETAMINOPHEN) SINCE 2011 AND RIVAROXABAN (XARELTO) SINCE 2013. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("SEVERE PELVIC PAIN/PELVIC PAIN"), ALLERGY TO METALS ("AN ALLERGIC REACTION TO THE NICKEL IN THE DEVICE/NICKEL ALLERGY"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), (B)(6) MONTHS (B)(6) DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND FATIGUE ("FATIGUE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), PAIN IN EXTREMITY ("LEG PAIN"). AND BACK PAIN ("LOWER BACK PAIN"). AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC LAPAROSCOPY REMOVAL OF WIDENED LEFT ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, EMBEDDED DEVICE, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE AND FATIGUE OUTCOME WAS UNKNOWN. AND THE GENITAL HAEMORRHAGE, PELVIC PAIN, ALLERGY TO METALS, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, PAIN IN EXTREMITY, BACK PAIN AND WEIGHT INCREASED HAD RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS, ANXIETY, BACK PAIN, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PAIN IN EXTREMITY, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS PLACED ON THE PATIENT'S LEFT SIDE. THIS WAS DONE WITHOUT DIFFICULTY FOR 3 COILS INTO TILE ENDOMETRIAL CAVITY. THEN ON THE PATIENT'S LEFT SIDE, THERE WAS SOME MALFUNCTION OF TILE DEVICE WHEN NEW DEVICE WAS USED. AND PHYSICIAN WAS ABLE TO PLACE THIS WITHOUT DIFFICULTY WITH 1 COIL SHOWING THROUGH THE ENDOMETRIAL CAVITY. THERE IS AN INCONSISTENCY. ALTHOUGH, PFS STATED, THAT PLAINTIFF HAD A DIAGNOSTIC LAPAROSCOPY, REMOVAL OF WIDENED LEFT ESSURE DEVICE. THE SURGICAL PATHOLOGY REPORT, STATED BILATERAL ESSURES. REMOVAL: SYNTHETIC HARDWARE CONSISTENT WITH ESSURE COILS IDENTIFIED (GROSS EXAMINATION). PLAINTIFF REVIVED TREATMENT FOR PAIN, ALLERGIC REACTION, MIGRATION, OTHER INJURY, SYMPTOM. LOT NUMBER#: 857599, MANUFACTURING DATE: 2011-05, EXPIRATION DATE:2014-05-30; LOT NUMBER#: 880431, MANUFACTURING DATE: 2011-07, EXPIRATION DATE:2014-07. QUALITY SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-SEP-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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF THE DEVICE") AND EMBEDDED DEVICE ("DEVICE EMBEDDED TO HER UTERUS") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("SEVERE PELVIC PAIN") AND ALLERGY TO METALS ("AN ALLERGIC REACTION TO THE NICKEL IN THE DEVICE"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6)2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, EMBEDDED DEVICE, PELVIC PAIN AND ALLERGY TO METALS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALLERGY TO METALS, DEVICE DISLOCATION, EMBEDDED DEVICE 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 |
|---|---|---|---|---|---|---|---|
| 544486 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 880431,857599 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| CELEXA| CELEXA| CELEXA| CETIRIZINE HYDROCHLORIDE| CETIRIZINE HYDROCHLORIDE| CETIRIZINE HYDROCHLORIDE| CITALOPRAM| CITALOPRAM| CITALOPRAM| CITALOPRAM| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS| XARELTO| XARELTO| XARELTO| XARELTO| XARELTO| XARELTO| ZYRTEC| ZYRTEC| ZYRTEC |