ESSURE
Report
- Report Number
- 2951250-2021-03167
- Event Type
- Injury
- Date Received
- September 8, 2021
- Report Date
- December 28, 2022
- 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
THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY (REFERENCE NUMBER: (B)(4)) ON 01-SEP-2021. THE MOST RECENT INFORMATION WAS RECEIVED ON 09-SEP-2021. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ("I WAS ALLERGIC TO CERTAIN METALS.I WAS ALLERGIC TO NICKEL AND TITANIUM") AND ARTHRALGIA ("OVER A 7 YEARS PERIOD, I BEGAN HAVING JOINT PAINS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. A25163). ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. THE ONLY CONCOMITANT PRODUCT MENTIONED WAS VITAMIN D [VITAMIN D NOS]. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, 248 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED ARTHRALGIA (SERIOUSNESS CRITERION DISABILITY), INFLAMMATION ("INFLAMMATION") AND NEUROLOGICAL SYMPTOM ("NEUROLOGICAL SYMPTOMS"). ESSURE WAS REMOVED ON (B)(6) 2021. AN UNKNOWN TIME LATER SHE EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED) WITH RASH AND BONE PAIN ("MY BONE PAIN HAS MINIMIZED TO ALMOST COMPLETELY GONE"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED). AT THE TIME OF THE REPORT, THE ARTHRALGIA, INFLAMMATION, NEUROLOGICAL SYMPTOM AND BONE PAIN HAD RESOLVED. THE OUTCOME OF ALLERGY TO METALS WAS UNKNOWN. THE REPORTER CONSIDERED ALLERGY TO METALS, ARTHRALGIA, BONE PAIN, INFLAMMATION AND NEUROLOGICAL SYMPTOM TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: AFTER THE SURGERY ALL OF MY RASHES WENT AWAY. MY INFLAMMATION WENT DOWN. MY BONE PAIN HAS MINIMIZED TO ALMOST COMPLETELY GONE.MY FLEXIBILITY IN MY JOINTS IS BACK. MY NEUROLOGICAL SYMPTOMS HAVE DISAPPEARED. LOT NUMBER:A25163. MANUFACTURING DATE: 2012-06. EXPIRATION DATE: 2015-06. 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 FOLLOWING AMENDMENT WAS MADE: UPON RECEIVING A INTERNAL REVIEW, IT WAS CONFIRMED THAT CASES (B)(4) AND (B)(4) ARE DUPLICATES OF EACH OTHER. ALL THE INFORMATION FROM DELETED DUPLICATE CASE (B)(4) HAS BEEN TRANSFERRED THE RETENTION CASE (B)(4). E2B COMPANY NUMBER ADDED. HENCE, THIS CASE SHOULD BE DELETED FROM BAYER DATA BASE. NULLIFICATION REASON: DUPLICATE CASE IS IDENTIFIED WITH FU INFORMATION. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (REFERENCE NUMBER: MW5103323) ON 01-SEP-2021. THE MOST RECENT INFORMATION WAS RECEIVED ON 09-SEP-2021. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ('I WAS ALLERGIC TO CERTAIN METALS.I WAS ALLERGIC TO NICKEL AND TITANIUM') AND ARTHRALGIA ('OVER A 7 YEARS PERIOD, I BEGAN HAVING JOINT PAINS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A25163) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED VITAMIN D NOS (VITAMIN D). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED ARTHRALGIA (SERIOUSNESS CRITERION DISABILITY), INFLAMMATION ("INFLAMMATION") AND NEUROLOGICAL SYMPTOM ("NEUROLOGICAL SYMPTOMS"), 8 MONTHS 5 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH RASH AND BONE PAIN ("MY BONE PAIN HAS MINIMIZED TO ALMOST COMPLETELY GONE"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE ALLERGY TO METALS OUTCOME WAS UNKNOWN AND THE ARTHRALGIA, INFLAMMATION, NEUROLOGICAL SYMPTOM AND BONE PAIN HAD RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS, ARTHRALGIA, BONE PAIN, INFLAMMATION AND NEUROLOGICAL SYMPTOM TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AFTER THE SURGERY ALL OF MY RASHES WENT AWAY. MY INFLAMMATION WENT DOWN. MY BONE PAIN HAS MINIMIZED TO ALMOST COMPLETELY GONE.MY FLEXIBILITY IN MY JOINTS IS BACK. MY NEUROLOGICAL SYMPTOMS HAVE DISAPPEARED. LOT NUMBER: A25163, MANUFACTURING DATE: 2012-06, AND EXPIRATION DATE: 2015-06. 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 9-SEP-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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (REFERENCE NUMBER: MW5103323) ON 01-SEP-2021. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ('I WAS ALLERGIC TO CERTAIN METALS.I WAS ALLERGIC TO NICKEL AND TITANIUM') AND ARTHRALGIA ('OVER A 7 YEARS PERIOD, I BEGAN HAVING JOINT PAINS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A25163) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED VITAMIN D NOS (VITAMIN D). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED ARTHRALGIA (SERIOUSNESS CRITERION DISABILITY), INFLAMMATION ("INFLAMMATION") AND NEUROLOGICAL SYMPTOM ("NEUROLOGICAL SYMPTOMS"), 8 MONTHS 5 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH RASH AND BONE PAIN ("MY BONE PAIN HAS MINIMIZED TO ALMOST COMPLETELY GONE"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE ALLERGY TO METALS OUTCOME WAS UNKNOWN AND THE ARTHRALGIA, INFLAMMATION, NEUROLOGICAL SYMPTOM AND BONE PAIN HAD RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS, ARTHRALGIA, BONE PAIN, INFLAMMATION AND NEUROLOGICAL SYMPTOM TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AFTER THE SURGERY ALL OF MY RASHES WENT AWAY. MY INFLAMMATION WENT DOWN. MY BONE PAIN HAS MINIMIZED TO ALMOST COMPLETELY GONE.MY FLEXIBILITY IN MY JOINTS IS BACK. MY NEUROLOGICAL SYMPTOMS HAVE DISAPPEARED. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1338990 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | A25163 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention| O | VITAMIN D [VITAMIN D NOS].| VITAMIN D [VITAMIN D NOS].| VITAMIN D [VITAMIN D NOS].| VITAMIN D [VITAMIN D NOS] |