ESSURE
Report
- Report Number
- 2951250-2017-09691
- Event Type
- Injury
- Date Received
- December 4, 2017
- Date of Event
- January 1, 2013
- Report Date
- April 5, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF INTRAPARTUM HAEMORRHAGE ("HEMORRHAGE AT DELIVERY"), RETAINED PLACENTA OR MEMBRANES ("RETAINED PLACENTA"), PELVIC PAIN ("PAIN") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (WITH COMPLICATIONS)") IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 822808-INVALID, 922606) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED D & C ON (B)(6) 2012, TERMINATION OF PREGNANCY ELECTIVE, D & C, PROLAPSED DISC REPAIR, POSTPARTUM HEMORRHAGE, MULTI GRAVIDA AND PARITY 4 (ON (B)(6) 2002, ON (B)(6) 2012, ON (B)(6) 2014). CONCURRENT CONDITIONS INCLUDED SCARRING, HEARTBURN AND BACK DISORDER. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN"). IN 2014, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INTRAPARTUM HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND RETAINED PLACENTA OR MEMBRANES (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (EMERGENCY HYSTERECTOMY AND ESSURE REMOVAL, HYSTERECTOMY ON (B)(6) 2014). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE INTRAPARTUM HAEMORRHAGE, RETAINED PLACENTA OR MEMBRANES, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: PROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, INTRAPARTUM HAEMORRHAGE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND RETAINED PLACENTA OR MEMBRANES TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT HAD RETAINED PLACENTA AND HEMORHAGE AT DELIVERY RESULTED IN EMERGENCY HYSTERECTOMY. THE ESSURE DEVICES, HOWEVER WAS PLACED IN THE LEFT TUBE WITHOUT INCIDENT. LOW PRESSURE HYSTEROGRAM WILL BE DONE 3 MONTHSPOST ¿ PROCEDURE TO CHECK FOR PATENCY OF THE TUBES SINCE THE RIGHT TUBE COULD VERY WELL BE BLOCKED FROM PRIOR EVENTS (UNSPECIFIED). DISCREPANCY IN DATE OF ESSURE REMOVAL: ON (B)(6) 2014. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM: IN JANUARY 2013: RESULTS: UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED). MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-JAN-2019: PLAINTIFF FACT SHEET WAS RECEIVED. REPORTER INFORMATION WAS UPDATED. 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
SPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF POSTPARTUM HAEMORRHAGE ("HEMORRHAGE AT DELIVERY"), RETAINED PLACENTA OR MEMBRANES ("RETAINED PLACENTA"), PELVIC PAIN ("PAIN") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (WITH COMPLICATIONS)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822808) INSERTED FOR FEMALE STERILISATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED D & C ON (B)(6) 2012, TERMINATION OF PREGNANCY - ELECTIVE, D & C, PROLAPSED DISC REPAIR AND POSTPARTUM HEMORRHAGE. CONCURRENT CONDITIONS INCLUDED SCARRING. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED POSTPARTUM HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RETAINED PLACENTA OR MEMBRANES (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (EMERGENCY HYSTERECTOMY), AND SURGERY (ESSURE REMOVAL, HYSTERECTOMY ON 05-DEC-2014). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE POSTPARTUM HAEMORRHAGE, RETAINED PLACENTA OR MEMBRANES, PELVIC PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED PELVIC PAIN, POSTPARTUM HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE AND RETAINED PLACENTA OR MEMBRANES TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT HAD RETAINED PLACENTA AND HEMORHAGE AT DELIVERY RESULTED IN EMERGENCY HYSTERECTOMY. THE ESSURE DEVICES, HOWEVER WAS PLACED IN THE LEFT TUBE WITHOUT INCIDENT. LOW PRESSURE HYSTEROGRAM WILL BE DONE 3 MONTHSPOST ¿ PROCEDURE TO CHECK FOR PATENCY OF THE TUBES SINCE THE RIGHT TUBE COULD VERY WELL BE BLOCKED FROM PRIOR EVENTS (UNSPECIFIED). MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET AND MEDICAL RECORD RECEIVED. REPORTER INFORMATION, PATIENT¿S DEMOGRAPHIC INFORMATION, RELEVANT HISTORY UPDATED. ESSURE LOT NUMBER, INDICATION WAS ADDED. ESSURE START DATE UPDATED FROM JUN-2012 TO (B)(6) 2012. EVENTS PREGNANCY WITH CONTRACEPTIVE DEVICE, RETAINED PLACENTA OR MEMBRANES, HAEMORRHAGE IN PREGNANCY, DEVICE INEFFECTIVE WERE NEWLY 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.
RESPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF INTRAPARTUM HAEMORRHAGE ("HEMORRHAGE AT DELIVERY"), RETAINED PLACENTA OR MEMBRANES ("RETAINED PLACENTA"), PELVIC PAIN ("PAIN") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (WITH COMPLICATIONS)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822808-INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED D & C ON (B)(6) 2012, TERMINATION OF PREGNANCY - ELECTIVE, D & C, PROLAPSED DISC REPAIR, POSTPARTUM HEMORRHAGE, MULTI GRAVIDA AND PARITY 4 (B)(6) 2002, (B)(6) 2012, (B)(6) 2012, (B)(6) 2014). CONCURRENT CONDITIONS INCLUDED SCARRING, HEARTBURN AND BACK DISORDER. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN"). IN 2014, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INTRAPARTUM HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RETAINED PLACENTA OR MEMBRANES (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (EMERGENCY HYSTERECTOMY) AND SURGERY (ESSURE REMOVAL, HYSTERECTOMY ON (B)(6) 2014). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE INTRAPARTUM HAEMORRHAGE, RETAINED PLACENTA OR MEMBRANES, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, INTRAPARTUM HAEMORRHAGE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND RETAINED PLACENTA OR MEMBRANES TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT HAD RETAINED PLACENTA AND HEMORHAGE AT DELIVERY RESULTED IN EMERGENCY HYSTERECTOMY. THE ESSURE DEVICES, HOWEVER WAS PLACED IN THE LEFT TUBE WITHOUT INCIDENT. LOW PRESSURE HYSTEROGRAM WILL BE DONE 3 MONTHSPOST ¿ PROCEDURE TO CHECK FOR PATENCY OF THE TUBES SINCE THE RIGHT TUBE COULD VERY WELL BE BLOCKED FROM PRIOR EVENTS (UNSPECIFIED). DISCREPANCY IN DATE OF ESSURE REMOVAL - (B)(6) 2014. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2013: UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED) QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET RECEIVED: REPORTER,HISTORICAL CONDITION, CONCOMITANT MEDICATION AND LOWER ABDOMEN PAIN EVENT WERE ADDED. 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 RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF INTRAPARTUM HAEMORRHAGE ("HEMORRHAGE AT DELIVERY"), RETAINED PLACENTA OR MEMBRANES ("RETAINED PLACENTA"), PELVIC PAIN ("PAIN") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (WITH COMPLICATIONS)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822808-INVALID) INSERTED FOR FEMALE STERILISATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED D & C ON (B)(6) 2012, TERMINATION OF PREGNANCY - ELECTIVE, D & C, PROLAPSED DISC REPAIR AND POSTPARTUM HEMORRHAGE. CONCURRENT CONDITIONS INCLUDED SCARRING. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INTRAPARTUM HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RETAINED PLACENTA OR MEMBRANES (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (EMERGENCY HYSTERECTOMY), SURGERY (EMERGENCY HYSTERECTOMY) AND SURGERY (ESSURE REMOVAL, HYSTERECTOMY ON (B)(6) 2014). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE INTRAPARTUM HAEMORRHAGE, RETAINED PLACENTA OR MEMBRANES, PELVIC PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED INTRAPARTUM HAEMORRHAGE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND RETAINED PLACENTA OR MEMBRANES TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT HAD RETAINED PLACENTA AND HEMORRHAGE AT DELIVERY RESULTED IN EMERGENCY HYSTERECTOMY. THE ESSURE DEVICES, HOWEVER WAS PLACED IN THE LEFT TUBE WITHOUT INCIDENT. LOW PRESSURE HYSTEROGRAM WILL BE DONE 3 MONTHS POST ¿ PROCEDURE TO CHECK FOR PATENCY OF THE TUBES SINCE THE RIGHT TUBE COULD VERY WELL BE BLOCKED FROM PRIOR EVENTS (UNSPECIFIED). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-AUG-2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 INTRAPARTUM HAEMORRHAGE ("HEMORRHAGE AT DELIVERY"), RETAINED PLACENTA OR MEMBRANES ("RETAINED PLACENTA"), PELVIC PAIN ("PAIN") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (WITH COMPLICATIONS)") IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822808-INVALID, 922606) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED D & C ON (B)(6)2012, TERMINATION OF PREGNANCY - ELECTIVE, D & C, PROLAPSED DISC REPAIR, POSTPARTUM HEMORRHAGE, MULTI GRAVIDA AND PARITY 4 ((B)(6)2002, (B)(6)2012, (B)(6)2012, (B)(6)2014)). CONCURRENT CONDITIONS INCLUDED SCARRING, HEARTBURN AND BACK DISORDER. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN"). IN 2014, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INTRAPARTUM HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND RETAINED PLACENTA OR MEMBRANES (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (EMERGENCY HYSTERECTOMY AND ESSURE REMOVAL, HYSTERECTOMY ON (B)(6)2014). ESSURE WAS REMOVED ON (B)(6)2014. AT THE TIME OF THE REPORT, THE INTRAPARTUM HAEMORRHAGE, RETAINED PLACENTA OR MEMBRANES, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: PROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, INTRAPARTUM HAEMORRHAGE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND RETAINED PLACENTA OR MEMBRANES TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT HAD RETAINED PLACENTA AND HEMORRHAGE AT DELIVERY RESULTED IN EMERGENCY HYSTERECTOMY. THE ESSURE DEVICES, HOWEVER WAS PLACED IN THE LEFT TUBE WITHOUT INCIDENT. LOW PRESSURE HYSTEROGRAM WILL BE DONE 3 MONTHSPOST ¿ PROCEDURE TO CHECK FOR PATENCY OF THE TUBES SINCE THE RIGHT TUBE COULD VERY WELL BE BLOCKED FROM PRIOR EVENTS (UNSPECIFIED). DISCREPANCY IN DATE OF ESSURE REMOVAL - (B)(6) 2014. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6)2013: RESULTS: UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-APR-2019: QUALITY SAFETY EVALUATION OF PTC. (PRODUCT TECHNICAL COMPLAINT). 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 ("PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED 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 |
|---|---|---|---|---|---|---|---|
| 858641 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822808-INVALID, 922606 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other| R |