ESSURE
Report
- Report Number
- 2951250-2024-00311
- Event Type
- Injury
- Date Received
- May 9, 2024
- Date of Event
- May 6, 2010
- Report Date
- July 17, 2024
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("I HAVE A LOT OF PELVIC SEVER PAIN ASSOCIATED WITH THE COILS SINCE DAY OF INSERTION") AND NERVE INJURY ("NERVE DAMAGE, EXTREME PAIN IN FALLOPIAN TUBES / I GAVE DAMAGED NERVES IN THE RIGHT THIGH / TWISTED A NERVE INTO THE COIL") IN A 48 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 822376) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. MEDICAL CONDITIONS: THERE IS NO MEDICAL HISTORY RELATED TO EVENTS. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, THE DAY OF ESSURE INSERTION, SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), NERVE INJURY (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), ADNEXA UTERI PAIN ("EXTREME PAIN IN FALLOPIAN TUBES"), ARTHRALGIA ("I WOKE FROM THE PROCEDURE I HAD AND EXTREME STABING PAIN IN MY RIGHT KNEE") AND PELVIC DISCOMFORT ("PELVIC DISCOMFORT"). THE PATIENT WAS TREATED WITH IBUPROFEN. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, NONE OF THE EVENTS HAD RESOLVED. THE REPORTER CONSIDERED ADNEXA UTERI PAIN, ARTHRALGIA, NERVE INJURY, PELVIC DISCOMFORT AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: EXPIRY DATE OF ESSURE: UNKNOWN. IT WAS POSSIBLE THAT SHE TWISTED UP A NERVE IN THE ESSURE COIL. NO INTERVENTION PERFORMED. LOT NUMBER:822376, MANUFACTURE DATE:2011-01, EXPIRATION DATE: 2014-01. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: 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. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 10-JUL-2024: PATIENTS DATE OF BIRTH ADDED. PATIENT GIVEN PERMISSION TO CONTACT HER PHYSICIAN TO COLLECT FURTHER INFORMATION ABOUT THE ADVERSE EVENTS. 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 CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("I HAVE A LOT OF PELVIC SEVER PAIN ASSOCIATED WITH THE COILS SINCE DAY OF INSERTION") AND NERVE INJURY ("NERVE DAMAGE, EXTREME PAIN IN FALLOPIAN TUBES / I GAVE DAMAGED NERVES IN THE RIGHT THIGH / TWISTED A NERVE INTO THE COIL") IN A 48 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 822376) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. MEDICAL CONDITIONS: THERE IS NO MEDICAL HISTORY RELATED TO EVENTS. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, THE DAY OF ESSURE INSERTION, SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), NERVE INJURY (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), ADNEXA UTERI PAIN ("EXTREME PAIN IN FALLOPIAN TUBES"), ARTHRALGIA ("I WOKE FROM THE PROCEDURE I HAD AND EXTREME STABING PAIN IN MY RIGHT KNEE") AND PELVIC DISCOMFORT ("PELVIC DISCOMFORT"). THE PATIENT WAS TREATED WITH IBUPROFEN. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, NONE OF THE EVENTS HAD RESOLVED. THE REPORTER CONSIDERED ADNEXA UTERI PAIN, ARTHRALGIA, NERVE INJURY, PELVIC DISCOMFORT AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: EXPIRY DATE OF ESSURE: UNKNOWN. IT WAS POSSIBLE THAT SHE TWISTED UP A NERVE IN THE ESSURE COIL. NO INTERVENTION PERFORMED. LOT NUMBER: 822376, MANUFACTURE DATE: 2011-01, EXPIRATION DATE: 2014-01. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: 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. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 10-MAY-2024: QUALITY SAFETY EVALUATION OF PTC. 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 CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("I HAVE A LOT OF PELVIC SEVER PAIN ASSOCIATED WITH THE COILS SINCE DAY OF INSERTION") AND NERVE INJURY ("NERVE DAMAGE, EXTREME PAIN IN FALLOPIAN TUBES / I GAVE DAMAGED NERVES IN THE RIGHT THIGH / TWISTED A NERVE INTO THE COIL") IN A 48 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 822376) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. MEDICAL CONDITIONS: THERE IS NO MEDICAL HISTORY RELATED TO EVENTS. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, THE DAY OF ESSURE INSERTION, SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), NERVE INJURY (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), ADNEXA UTERI PAIN ("EXTREME PAIN IN FALLOPIAN TUBES"), ARTHRALGIA ("I WOKE FROM THE PROCEDURE I HAD AND EXTREME STABBING PAIN IN MY RIGHT KNEE") AND PELVIC DISCOMFORT ("PELVIC DISCOMFORT"). THE PATIENT WAS TREATED WITH IBUPROFEN. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, NONE OF THE EVENTS HAD RESOLVED. THE REPORTER CONSIDERED ADNEXA UTERI PAIN, ARTHRALGIA, NERVE INJURY, PELVIC DISCOMFORT AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: EXPIRY DATE OF ESSURE: UNKNOWN. IT WAS POSSIBLE THAT SHE TWISTED UP A NERVE IN THE ESSURE COIL. NO INTERVENTION PERFORMED. LOT NUMBER:822376, MANUFACTURE DATE:2011-01, EXPIRATION DATE: 2014-01. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: 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. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 21-MAY-2024: QUALITY SAFETY EVALUATION OF PTC. 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 CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("I HAVE A LOT OF PELVIC SEVER PAIN ASSOCIATED WITH THE COILS SINCE DAY OF INSERTION") AND NERVE INJURY ("NERVE DAMAGE, EXTREME PAIN IN FALLOPIAN TUBES / I GAVE DAMAGED NERVES IN THE RIGHT THIGH / TWISTED A NERVE INTO THE COIL") IN A 48 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 822376) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. MEDICAL CONDITIONS: THERE IS NO MEDICAL HISTORY RELATED TO EVENTS. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, THE DAY OF ESSURE INSERTION, SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), NERVE INJURY (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), ADNEXA UTERI PAIN ("EXTREME PAIN IN FALLOPIAN TUBES"), ARTHRALGIA ("I WOKE FROM THE PROCEDURE I HAD AND EXTREME STABING PAIN IN MY RIGHT KNEE") AND PELVIC DISCOMFORT ("PELVIC DISCOMFORT"). THE PATIENT WAS TREATED WITH IBUPROFEN. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, NONE OF THE EVENTS HAD RESOLVED. THE REPORTER CONSIDERED ADNEXA UTERI PAIN, ARTHRALGIA, NERVE INJURY, PELVIC DISCOMFORT AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: EXPIRY DATE OF ESSURE: UNKNOWN. IT WAS POSSIBLE THAT SHE TWISTED UP A NERVE IN THE ESSURE COIL. NO INTERVENTION PERFORMED. LOT NUMBER:822376, MANUFACTURE DATE:2011-01, EXPIRATION DATE: 2014-01. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: UNABLE TO CONFIRM COMPLAINT THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 15-APR-2024: QUALITY SAFETY EVALUATION OF PTC. 16-APR-2024: CASE IS UPGRADED TO S3 FROM S1 AS EVENT PELVIC PAIN IS UPDATED TO SERIOUS AS START DATE OF PELVIC PAIN IS UPDATED TO 06-MAY-2010 (CHRONIC PELVIC PAIN). OUTCOME FOR PELVIC PAIN AND ARTHRALGIA EVENT ADDED. NEW EVENT ADDED: PELVIC DISCOMFORT. PATIENT NOTES AND REPORTER CAUSALITY COMMENT UPDATED. EVENT START DATE UPDATED. SERIOUSNESS AND F CODE UPDATED. 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 |
|---|---|---|---|---|---|---|---|
| 1359137 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | 822376 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Female | Other |