ESSURE
Report
- Report Number
- 2951250-2019-00010
- Event Type
- Injury
- Date Received
- January 2, 2019
- Date of Event
- June 23, 2012
- Report Date
- July 6, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PERSISTENT PELVIC PAIN') AND DEVICE DISLOCATION ('MIGRATION') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940870-NOT VALID, 869752) 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 "ESSURE CONFIRMATION TEST NOT DONE". THE PATIENT'S MEDICAL HISTORY INCLUDED VITAMIN D DEFICIENCY. CONCOMITANT PRODUCTS INCLUDED FERROUS FUMARATE, IBUPROFEN, IBUPROFEN (MOTRIN CHILDREN), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION AND MENTAL ANGUISH"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION AND MENTAL ANGUISH") AND ANAEMIA ("BLOOD OR HEART DISORDER/CONDITION TYPE: ANEMIA"), 9 MONTHS 23 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2018, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: UTERINE FIBROIDS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENSTRUAL DISORDER ("MENSTRUAL ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED AND THE DEVICE DISLOCATION, MENSTRUAL DISORDER, ANXIETY, DEPRESSION, ANAEMIA AND UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANAEMIA, ANXIETY, DEPRESSION, DEVICE DISLOCATION, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, UTERINE LEIOMYOMA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF SUFFERED PHYSICAL PAIN AND EMOTIONAL ANGUISH BECAUSE OF THE ESSURE® DEVICE. INSERTION DATE DISCREPANCY NOTED IN PFS FROM (B)(6) 2019. PROCEDURE (ESSURE INSERTION) PERFORMED AS BEFORE USING STERILE TECHNIQUE AND THE RIGHT TUBE VISUALIZED WITH ESSURE DEVICE IN PLACE, HOWEVER, THE ESSURE DEVICE WAS NOTED TO BE PARTIALLY IMBEDDED IN WHAT APPEARS TO BE THE LOCATION OF THE LEFT OSTIA BUT THE MAJORITY OF THE DEVICE IN THE UTERINE CAVITY. IT WAS REMOVED. REPEATED ATTEMPTS AT LOCALIZING AND CANNULATING THE LEFT TUBAL OSTIA WERE UNSUCCESSFUL. CANNOT SEE THE ENTRANCE CLEARLY EVEN THOUGH THE GENERAL LOCATION SEEM. IN (B)(6) 2012 THE LEFT FALLOPIAN TUBE OSTIA WAS IDENTIFIED AND EASILY CANNULATED WITH THE ESSURE APPLICATOR PROBE AND THE COIL PLACED WITH 3 COILS NOTED OUTSIDE THE OSTIA. PATIENT HAD REPEAT ESSURE (B)(6) 2013. THE LEFT FALLOPIAN TUBE HAD FAILED. DISCREPANCY NOTED AS INSERTION DATE : (B)(6) 2012. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: UTERINE LEIOMYOMA, MENORRHAGIA, ANEMIA, PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED. NEW EVENTS ADDED: MIGRATION. OUTCOME OF PREVIOUSLY ADDED EVENTS PELVIC PAIN, MENORRHAGIA WERE UPDATED TO RECOVERED/RESOLVED. 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 ('PERSISTENT PELVIC PAIN') AND DEVICE DISLOCATION ('MIGRATION') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940870-INVALID, 869752) 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 "ESSURE CONFIRMATION TEST NOT DONE". THE PATIENT'S MEDICAL HISTORY INCLUDED VITAMIN D DEFICIENCY. CONCOMITANT PRODUCTS INCLUDED FERROUS FUMARATE, IBUPROFEN, IBUPROFEN (MOTRIN CHILDREN), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION AND MENTAL ANGUISH"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION AND MENTAL ANGUISH") AND ANAEMIA ("BLOOD OR HEART DISORDER/CONDITION TYPE: ANEMIA"), 9 MONTHS 23 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2018, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: UTERINE FIBROIDS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENSTRUAL DISORDER ("MENSTRUAL ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED AND THE DEVICE DISLOCATION, MENSTRUAL DISORDER, ANXIETY, DEPRESSION, ANAEMIA AND UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANAEMIA, ANXIETY, DEPRESSION, DEVICE DISLOCATION, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, UTERINE LEIOMYOMA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF SUFFERED PHYSICAL PAIN AND EMOTIONAL ANGUISH BECAUSE OF THE ESSURE® DEVICE. INSERTION DATE DISCREPANCY NOTED IN PFS FROM (B)(6) 2019. PROCEDURE (ESSURE INSERTION) PERFORMED AS BEFORE USING STERILE TECHNIQUE AND THE RIGHT TUBE VISUALIZED WITH ESSURE DEVICE IN PLACE, HOWEVER, THE ESSURE DEVICE WAS NOTED TO BE PARTIALLY IMBEDDED IN WHAT APPEARS TO BE THE LOCATION OF THE LEFT OSTIA BUT THE MAJORITY OF THE DEVICE IN THE UTERINE CAVITY. IT WAS REMOVED. REPEATED ATTEMPTS AT LOCALIZING AND CANNULATING THE LEFT TUBAL OSTIA WERE UNSUCCESSFUL. CANNOT SEE THE ENTRANCE CLEARLY EVEN THOUGH THE GENERAL LOCATION SEEM. IN (B)(6) 2012 THE LEFT FALLOPIAN TUBE OSTIA WAS IDENTIFIED AND EASILY CANNULATED WITH THE ESSURE APPLICATOR PROBE AND THE COIL PLACED WITH 3 COILS NOTED OUTSIDE THE OSTIA. PATIENT HAD REPEAT ESSURE (B)(6) 2013. THE LEFT FALLOPIAN TUBE HAD FAILED. DISCREPANCY NOTED AS INSERTION DATE : (B)(6) 2012. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: UTERINE LEIOMYOMA, MENORRHAGIA, ANEMIA, PELVIC PAIN. LOT NUMBER ( 940870) IS INVALID. LOT NUMBER: 869752 MANUFACTURING 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 18-JUN-2020: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). 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 ('PERSISTENT PELVIC PAIN') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940870-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 "ESSURE CONFIRMATION TEST NOT DONE". THE PATIENT'S MEDICAL HISTORY INCLUDED VITAMIN D DEFICIENCY. CONCOMITANT PRODUCTS INCLUDED FERROUS FUMARATE, IBUPROFEN, IBUPROFEN (MOTRIN CHILDREN), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION AND MENTAL ANGUISH"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION AND MENTAL ANGUISH") AND ANAEMIA ("BLOOD OR HEART DISORDER/CONDITION TYPE: ANEMIA"), 3 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2018, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: UTERINE FIBROIDS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUAL ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING, THE MENSTRUAL DISORDER, MENORRHAGIA, ANXIETY, DEPRESSION, ANAEMIA AND UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN AND THE VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ANAEMIA, ANXIETY, DEPRESSION, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, UTERINE LEIOMYOMA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF SUFFERED PHYSICAL PAIN AND EMOTIONAL ANGUISH BECAUSE OF THE ESSURE® DEVICE. INSERTION DATE DISCREPANCY NOTED IN PFS FROM (B)(6) 2019. PROCEDURE (ESSURE INSERTION) PERFORMED AS BEFORE USING STERILE TECHNIQUE AND THE RIGHT TUBE VISUALIZED WITH ESSURE DEVICE IN PLACE, HOWEVER, THE ESSURE DEVICE WAS NOTED TO BE PARTIALLY IMBEDDED IN WHAT APPEARS TO BE THE LOCATION OF THE LEFT OSTIA BUT THE MAJORITY OF THE DEVICE IN THE UTERINE CAVITY. IT WAS REMOVED. REPEATED ATTEMPTS AT LOCALIZING AND CANNULATING THE LEFT TUBAL OSTIA WERE UNSUCCESSFUL. CANNOT SEE THE ENTRANCE CLEARLY EVEN THOUGH THE GENERAL LOCATION SEEM. IN (B)(6) 2012 THE LEFT FALLOPIAN TUBE OSTIA WAS IDENTIFIED AND EASILY CANNULATED WITH THE ESSURE APPLICATOR PROBE AND THE COIL PLACED WITH 3 COILS NOTED OUTSIDE THE OSTIA. PATIENT HAD REPEAT ESSURE (B)(6) 2013. THE LEFT FALLOPIAN TUBE HAD FAILED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: UTERINE LEIOMYOMA, MENORRHAGIA, ANEMIA, PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-MAY-2019: UPDATE OF INFORMATION (BATCH IS INVALID) PRODUCT TECHNICAL COMPLIANT. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PERSISTENT PELVIC PAIN') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940870) 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 "ESSURE CONFIRMATION TEST NOT DONE". THE PATIENT'S MEDICAL HISTORY INCLUDED VITAMIN D DEFICIENCY. CONCOMITANT PRODUCTS INCLUDED FERROUS FUMARATE, IBUPROFEN, IBUPROFEN (MOTRIN CHILDREN), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION AND MENTAL ANGUISH"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION AND MENTAL ANGUISH") AND ANAEMIA ("BLOOD OR HEART DISORDER/CONDITION TYPE: ANEMIA"), 3 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2018, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: UTERINE FIBROIDS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUAL ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING, THE MENSTRUAL DISORDER, MENORRHAGIA, ANXIETY, DEPRESSION, ANAEMIA AND UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN AND THE VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ANAEMIA, ANXIETY, DEPRESSION, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, UTERINE LEIOMYOMA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF SUFFERED PHYSICAL PAIN AND EMOTIONAL ANGUISH BECAUSE OF THE ESSURE® DEVICE. INSERTION DATE DISCREPANCY NOTED IN PFS FROM (B)(6) 2019. PROCEDURE (ESSURE INSERTION) PERFORMED AS BEFORE USING STERILE TECHNIQUE AND THE RIGHT TUBE VISUALIZED WITH ESSURE DEVICE IN PLACE, HOWEVER, THE ESSURE DEVICE WAS NOTED TO BE PARTIALLY IMBEDDED IN WHAT APPEARS TO BE THE LOCATION OF THE LEFT OSTIA BUT THE MAJORITY OF THE DEVICE IN THE UTERINE CAVITY. IT WAS REMOVED. REPEATED ATTEMPTS AT LOCALIZING AND CANNULATING THE LEFT TUBAL OSTIA WERE UNSUCCESSFUL. CANNOT SEE THE ENTRANCE CLEARLY EVEN THOUGH THE GENERAL LOCATION SEEM. IN (B)(6) 2012 THE LEFT FALLOPIAN TUBE OSTIA WAS IDENTIFIED AND EASILY CANNULATED WITH THE ESSURE APPLICATOR PROBE AND THE COIL PLACED WITH 3 COILS NOTED OUTSIDE THE OSTIA. PATIENT HAD REPEAT ESSURE (B)(6) 2013. THE LEFT FALLOPIAN TUBE HAD FAILED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: UTERINE LEIOMYOMA, MENORRHAGIA, ANEMIA, PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-MAY-2019: PFS AND MR RECEIVED : AKA NAME ADDED, REPORTER ADDED, LOT NUMBER ADDED, PATIENT DEMOGRAPHIC ADDED, ESSURE INSERTION DATE AND REMOVAL DATE UPDATED, EVENTS ADDED- ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), DEPRESSION, MENTAL ANGUISH, ANEMIA, UTERINE FIBROIDS, DEVICE MONITORING PROCEDURE NOT PERFORMED. EVENTS OUTCOME UPDATED, EVENTS ONSET DATE, EVENTS SEVERITY , CONCOMITANT DRUG AND MEDICAL HISTORY ADDED. INCIDENT WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PERSISTENT PELVIC PAIN") 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) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENSTRUAL DISORDER ("MENSTRUAL ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENSTRUAL DISORDER 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 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 ("PERSISTENT PELVIC PAIN") 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) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENSTRUAL DISORDER ("MENSTRUAL ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENSTRUAL DISORDER 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 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 |
|---|---|---|---|---|---|---|---|
| 1013 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 940870-INVALID, 869752 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| FERROUS FUMARATE| FERROUS FUMARATE| FERROUS FUMARATE| FERROUS FUMARATE| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| MOTRIN CHILDREN| MOTRIN CHILDREN| MOTRIN CHILDREN| MOTRIN CHILDREN |