ESSURE
Report
- Report Number
- 2951250-2021-02469
- Event Type
- Injury
- Date Received
- May 28, 2021
- Report Date
- February 15, 2022
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('SEVERE CHRONIC PAIN IN THE ABDOMEN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 945067) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ONE OF THE ESSURE INSERTED IN FEB-2015, WAS EXPIRED (EXPIRATION DATE: (B)(6) 2015)" IN (B)(6) 2015 AND EXPIRED DEVICE USED "ONE OF THE ESSURE INSERTED IN (B)(6) 2015, WAS EXPIRED (EXPIRATION DATE: JAN-2015)" IN (B)(6) 2015. IN (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), BACK PAIN ("SEVERE CHRONIC PAIN IN THE BACK"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), MENSTRUATION IRREGULAR ("CHANGE IN THEIR MENSTRUATION CYCLE / ABNORMALLY LARGE AMOUNT OF BLOOD LOSS"), HEAVY MENSTRUAL BLEEDING ("CHANGE IN THEIR MENSTRUATION CYCLE / ABNORMALLY LARGE AMOUNT OF BLOOD LOSS"), HEADACHE ("SEVERE CHRONIC PAIN IN THE HEAD"), AMNESIA ("MEMORY LOSS"), ARTHRALGIA ("SEVERE CHRONIC PAIN IN THE HIPS"), DISTURBANCE IN ATTENTION ("CONCENTRATION PROBLEMS") AND FATIGUE ("EXTREME AND CHRONIC FATIGUE") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED IN (B)(6) 2017. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, BACK PAIN, HYPERSENSITIVITY, MENSTRUATION IRREGULAR, HEAVY MENSTRUAL BLEEDING, HEADACHE, AMNESIA, ARTHRALGIA, DISTURBANCE IN ATTENTION, HORMONE LEVEL ABNORMAL AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, AMNESIA, ARTHRALGIA, BACK PAIN, DISTURBANCE IN ATTENTION, FATIGUE, HEADACHE, HEAVY MENSTRUAL BLEEDING, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY AND MENSTRUATION IRREGULAR TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE SYMPTOMS DECREASED WHEN THE ESSURE WAS REMOVED AND ALL OF THE COMPLAINTS DISAPPEARED. TWO ESSURE INSERTION DATES HAVE BEEN REPORTED: (B)(6) 2014 AND (B)(6) 2015. LOT NUMBER: 945067 MANUFACTURING DATE: 2012/01 EXPIRATION DATE: 2015/01. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-MAY-2021: THE DATE OF INSERTION AND REMOVAL OF ESSURE HAS BEEN UPDATED. TWO ADVERSE EVENTS WERE ADDED:EXPIRED DEVICE USED AND DEVICE MONITORING ERROR. 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 ABDOMINAL PAIN ('SEVERE CHRONIC PAIN IN THE ABDOMEN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 945067) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ONE OF THE ESSURE INSERTED IN (B)(6) 2015, WAS EXPIRED (EXPIRATION DATE: (B)(6) 2015)" IN (B)(6) 2015 AND EXPIRED DEVICE USED "ONE OF THE ESSURE INSERTED IN (B)(6) 2015, WAS EXPIRED (EXPIRATION DATE: (B)(6) 2015)" IN (B)(6) 2015. IN (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), BACK PAIN ("SEVERE CHRONIC PAIN IN THE BACK"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), MENSTRUATION IRREGULAR ("CHANGE IN THEIR MENSTRUATION CYCLE / ABNORMALLY LARGE AMOUNT OF BLOOD LOSS"), HEAVY MENSTRUAL BLEEDING ("CHANGE IN THEIR MENSTRUATION CYCLE / ABNORMALLY LARGE AMOUNT OF BLOOD LOSS"), HEADACHE ("SEVERE CHRONIC PAIN IN THE HEAD"), AMNESIA ("MEMORY LOSS"), ARTHRALGIA ("SEVERE CHRONIC PAIN IN THE HIPS"), DISTURBANCE IN ATTENTION ("CONCENTRATION PROBLEMS") AND FATIGUE ("EXTREME AND CHRONIC FATIGUE") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED IN (B)(6) 2017. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, BACK PAIN, HYPERSENSITIVITY, MENSTRUATION IRREGULAR, HEAVY MENSTRUAL BLEEDING, HEADACHE, AMNESIA, ARTHRALGIA, DISTURBANCE IN ATTENTION, HORMONE LEVEL ABNORMAL AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, AMNESIA, ARTHRALGIA, BACK PAIN, DISTURBANCE IN ATTENTION, FATIGUE, HEADACHE, HEAVY MENSTRUAL BLEEDING, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY AND MENSTRUATION IRREGULAR TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TWO ESSURE INSERTION DATES WERE REPORTED: (B)(6) 2014 AND (B)(6) 2015. LOT NUMBER: 945067, MANUFACTURING DATE: 2012/01, AND EXPIRATION DATE: 2015/01. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. 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 COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-JUN-2021: QUALITY-SAFETY EVALUATION OF PTC. ON 2-JUN-2021: ALL REQUIRED FOLLOW-UP ATTEMPTS WERE COMPLETED. 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 ABDOMINAL PAIN ('SEVERE CHRONIC PAIN IN THE ABDOMEN/ PAIN') AND FALLOPIAN TUBE PERFORATION ('PERFORATION OF THE FALLOPIAN TUBES') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 945067) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: EXPIRED DEVICE USED "ONE OF THE ESSURE INSERTED IN (B)(6) 2015, WAS EXPIRED (EXPIRATION DATE: (B)(6) 2015)" IN (B)(6) 2015 AND MEDICAL DEVICE MONITORING ERROR "ONE OF THE ESSURE INSERTED IN (B)(6) 2015, WAS EXPIRED (EXPIRATION DATE: (B)(6) 2015)" IN (B)(6) 2015. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("SEVERE CHRONIC PAIN IN THE BACK"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), MENSTRUATION IRREGULAR ("CHANGE IN THEIR MENSTRUATION CYCLE / ABNORMALLY LARGE AMOUNT OF BLOOD LOSS"), HEAVY MENSTRUAL BLEEDING ("CHANGE IN THEIR MENSTRUATION CYCLE / ABNORMALLY LARGE AMOUNT OF BLOOD LOSS"), HEADACHE ("SEVERE CHRONIC PAIN IN THE HEAD"), AMNESIA ("MEMORY LOSS"), ARTHRALGIA ("SEVERE CHRONIC PAIN IN THE HIPS"), DISTURBANCE IN ATTENTION ("CONCENTRATION PROBLEMS"), FATIGUE ("EXTREME AND CHRONIC FATIGUE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING"), AUTOIMMUNE DISORDER ("AUTOIMMUNE PROBLEMS"), MENTAL DISORDER ("PSYCHOLOGICAL PROBLEMS"), ALOPECIA ("HAIR LOSS") AND DYSPAREUNIA ("DYSPAREUNIA") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED IN (B)(6) 2017. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, BACK PAIN, HYPERSENSITIVITY, MENSTRUATION IRREGULAR, HEAVY MENSTRUAL BLEEDING, HEADACHE, AMNESIA, ARTHRALGIA, DISTURBANCE IN ATTENTION, HORMONE LEVEL ABNORMAL AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, AMNESIA, ARTHRALGIA, AUTOIMMUNE DISORDER, BACK PAIN, DISTURBANCE IN ATTENTION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, HEADACHE, HEAVY MENSTRUAL BLEEDING, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, MENSTRUATION IRREGULAR, MENTAL DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TWO ESSURE INSERTION DATES WERE REPORTED: (B)(6) 2014 ( AMENDED TO (B)(6) 2014) AND (B)(6) 2015. LOT NUMBER: 945067, MANUFACTURING DATE: 2012/01, AND EXPIRATION DATE: 2015/01. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. 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 COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-JAN-2022: REPORTER ADDED, "VAGINAL BLEEDING", "PERFORATION OF FALLOPIAN TUBE", "HAIR LOSS", "DYSPAREUNIA", "AUTOIMMUNE DISORDER", "MENTAL DISORDER" ADDED AS EVENT. 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 ABDOMINAL PAIN ('SEVERE CHRONIC PAIN IN THE ABDOMEN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 945067) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ONE OF THE ESSURE INSERTED IN (B)(6) 2015, WAS EXPIRED (EXPIRATION DATE: (B)(6) 2015)" IN (B)(6) 2015 AND EXPIRED DEVICE USED "ONE OF THE ESSURE INSERTED IN (B)(6) 2015, WAS EXPIRED (EXPIRATION DATE: (B)(6) 2015)" IN (B)(6) 2015. IN (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), BACK PAIN ("SEVERE CHRONIC PAIN IN THE BACK"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), MENSTRUATION IRREGULAR ("CHANGE IN THEIR MENSTRUATION CYCLE / ABNORMALLY LARGE AMOUNT OF BLOOD LOSS"), HEAVY MENSTRUAL BLEEDING ("CHANGE IN THEIR MENSTRUATION CYCLE / ABNORMALLY LARGE AMOUNT OF BLOOD LOSS"), HEADACHE ("SEVERE CHRONIC PAIN IN THE HEAD"), AMNESIA ("MEMORY LOSS"), ARTHRALGIA ("SEVERE CHRONIC PAIN IN THE HIPS"), DISTURBANCE IN ATTENTION ("CONCENTRATION PROBLEMS") AND FATIGUE ("EXTREME AND CHRONIC FATIGUE") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED IN (B)(6) 2017. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, BACK PAIN, HYPERSENSITIVITY, MENSTRUATION IRREGULAR, HEAVY MENSTRUAL BLEEDING, HEADACHE, AMNESIA, ARTHRALGIA, DISTURBANCE IN ATTENTION, HORMONE LEVEL ABNORMAL AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, AMNESIA, ARTHRALGIA, BACK PAIN, DISTURBANCE IN ATTENTION, FATIGUE, HEADACHE, HEAVY MENSTRUAL BLEEDING, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY AND MENSTRUATION IRREGULAR TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TWO ESSURE INSERTION DATES WERE REPORTED: (B)(6) 2014 AND (B)(6) 2015. LOT NUMBER: 945067, MANUFACTURING DATE: 2012/01, EXPIRATION DATE: 2015/01. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. 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 COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-JUN-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 ABDOMINAL PAIN ('SEVERE CHRONIC PAIN IN THE ABDOMEN/ PAIN') AND FALLOPIAN TUBE PERFORATION ('PERFORATION OF THE FALLOPIAN TUBES') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 945067) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: EXPIRED DEVICE USED "ONE OF THE ESSURE INSERTED IN (B)(6) 2015, WAS EXPIRED (EXPIRATION DATE: JAN-2015)" IN (B)(6) 2015 AND MEDICAL DEVICE MONITORING ERROR "ONE OF THE ESSURE INSERTED IN (B)(6) 2015, WAS EXPIRED (EXPIRATION DATE: JAN-2015)" IN (B)(6) 2015. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("SEVERE CHRONIC PAIN IN THE BACK"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), MENSTRUATION IRREGULAR ("CHANGE IN THEIR MENSTRUATION CYCLE / ABNORMALLY LARGE AMOUNT OF BLOOD LOSS"), HEAVY MENSTRUAL BLEEDING ("CHANGE IN THEIR MENSTRUATION CYCLE / ABNORMALLY LARGE AMOUNT OF BLOOD LOSS"), HEADACHE ("SEVERE CHRONIC PAIN IN THE HEAD"), AMNESIA ("MEMORY LOSS"), ARTHRALGIA ("SEVERE CHRONIC PAIN IN THE HIPS"), DISTURBANCE IN ATTENTION ("CONCENTRATION PROBLEMS"), FATIGUE ("EXTREME AND CHRONIC FATIGUE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING"), AUTOIMMUNE DISORDER ("AUTOIMMUNE PROBLEMS"), MENTAL DISORDER ("PSYCHOLOGICAL PROBLEMS"), ALOPECIA ("HAIR LOSS") AND DYSPAREUNIA ("DYSPAREUNIA") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED IN (B)(6) 2017. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, BACK PAIN, HYPERSENSITIVITY, MENSTRUATION IRREGULAR, HEAVY MENSTRUAL BLEEDING, HEADACHE, AMNESIA, ARTHRALGIA, DISTURBANCE IN ATTENTION, HORMONE LEVEL ABNORMAL AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, AMNESIA, ARTHRALGIA, AUTOIMMUNE DISORDER, BACK PAIN, DISTURBANCE IN ATTENTION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, HEADACHE, HEAVY MENSTRUAL BLEEDING, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, MENSTRUATION IRREGULAR, MENTAL DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TWO ESSURE INSERTION DATES WERE REPORTED: (B)(6) 2014 (AMENDED TO (B)(6) 2014) AND (B)(6) 2015. LOT NUMBER: 945067, MANUFACTURING DATE: 2012/01, EXPIRATION DATE: 2015/01. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. 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 COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-FEB-2022: 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 ABDOMINAL PAIN ('SEVERE CHRONIC PAIN IN THE ABDOMEN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 945067) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ONE OF THE ESSURE INSERTED IN (B)(6) 2015, WAS EXPIRED (EXPIRATION DATE: JAN-2015)" IN (B)(6) 2015 AND EXPIRED DEVICE USED "ONE OF THE ESSURE INSERTED IN (B)(6) 2015, WAS EXPIRED (EXPIRATION DATE: JAN-2015)" IN (B)(6) 2015. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), BACK PAIN ("SEVERE CHRONIC PAIN IN THE BACK"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), MENSTRUATION IRREGULAR ("CHANGE IN THEIR MENSTRUATION CYCLE / ABNORMALLY LARGE AMOUNT OF BLOOD LOSS"), HEAVY MENSTRUAL BLEEDING ("CHANGE IN THEIR MENSTRUATION CYCLE/ABNORMALLY LARGE AMOUNT OF BLOOD LOSS"), HEADACHE ("SEVERE CHRONIC PAIN IN THE HEAD"), AMNESIA ("MEMORY LOSS"), ARTHRALGIA ("SEVERE CHRONIC PAIN IN THE HIPS"), DISTURBANCE IN ATTENTION ("CONCENTRATION PROBLEMS") AND FATIGUE ("EXTREME AND CHRONIC FATIGUE") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED IN (B)(6) 2017. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, BACK PAIN, HYPERSENSITIVITY, MENSTRUATION IRREGULAR, HEAVY MENSTRUAL BLEEDING, HEADACHE, AMNESIA, ARTHRALGIA, DISTURBANCE IN ATTENTION, HORMONE LEVEL ABNORMAL AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, AMNESIA, ARTHRALGIA, BACK PAIN, DISTURBANCE IN ATTENTION, FATIGUE, HEADACHE, HEAVY MENSTRUAL BLEEDING, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY AND MENSTRUATION IRREGULAR TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TWO ESSURE INSERTION DATES WERE REPORTED: (B)(6) 2014 (AMENDED TO (B)(6) 2014) AND (B)(6) 2015. LOT NUMBER: 945067. MANUFACTURING DATE: 2012/01. EXPIRATION DATE: 2015/01. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. 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 COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-JUL-2021: THE INSERTION DATE WAS AMENDED FROM (B)(6) 2014 TO (B)(6) 2014. 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 ABDOMINAL PAIN ('SEVERE CHRONIC PAIN IN THE ABDOMEN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 945067) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), BACK PAIN ("SEVERE CHRONIC PAIN IN THE BACK"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), MENSTRUATION IRREGULAR ("CHANGE IN THEIR MENSTRUATION CYCLE / ABNORMALLY LARGE AMOUNT OF BLOOD LOSS"), HEAVY MENSTRUAL BLEEDING ("CHANGE IN THEIR MENSTRUATION CYCLE / ABNORMALLY LARGE AMOUNT OF BLOOD LOSS"), HEADACHE ("SEVERE CHRONIC PAIN IN THE HEAD"), AMNESIA ("MEMORY LOSS"), ARTHRALGIA ("SEVERE CHRONIC PAIN IN THE HIPS"), DISTURBANCE IN ATTENTION ("CONCENTRATION PROBLEMS") AND FATIGUE ("EXTREME AND CHRONIC FATIGUE") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, BACK PAIN, HYPERSENSITIVITY, MENSTRUATION IRREGULAR, HEAVY MENSTRUAL BLEEDING, HEADACHE, AMNESIA, ARTHRALGIA, DISTURBANCE IN ATTENTION, HORMONE LEVEL ABNORMAL AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, AMNESIA, ARTHRALGIA, BACK PAIN, DISTURBANCE IN ATTENTION, FATIGUE, HEADACHE, HEAVY MENSTRUAL BLEEDING, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY AND MENSTRUATION IRREGULAR TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE SYMPTOMS DECREASED WHEN THE ESSURE WAS REMOVED AND ALL OF THE COMPLAINTS DISAPPEARED. LOT NUMBER: 945067, MANUFACTURING DATE: 2012/01, EXPIRATION DATE: 2015/01. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-MAY-2021: THE CASE WAS UPDATED TO SERIOUS-INCIDENT, THE FOLLOW INFORMATION WERE UPDATED REPORT, PATIENT INFORMATION, MEDICAL DEVICE REMOVAL YES, MEMORY LOSS, CHRONIC BACK PAIN, PAIN IN HIP, HEADACHE, CONCENTRATION IMPAIRMENT, MENSTRUATION IRREGULAR, BLEEDING MENSTRUAL HEAVY, HORMONAL IMBALANCE, ALLERGIC REACTIONS, CHRONIC FATIGUE, INJURY NOS WAS UPDATED TO CHRONIC ABDOMINAL PAIN. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 800889 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 945067 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention| O |