ESSURE
Report
- Report Number
- 2951250-2020-08123
- Event Type
- Injury
- Date Received
- May 25, 2020
- Report Date
- May 25, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PAIN ('PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893029) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSION, ANXIETY, BREAST CANCER, DYSFUNCTIONAL UTERINE BLEEDING, SEIZURE, MASTECTOMY BILATERAL, NASAL OPERATION, SEPTOPLASTY, CHEMOTHERAPY, CEPHALGIA, OVARIAN CYST AND CERVICITIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: SUBOXONE AND EFFEXOR. CONCOMITANT PRODUCTS INCLUDED CLONAZEPAM, GABAPENTIN, TIZANIDINE AND VENLAFAXINE HYDROCHLORIDE (EFFEXOR). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") AND PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED ON (B)(6) 2019,HYSTERECTOMY + BI-S). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PAIN AND GENITAL HAEMORRHAGE HAD RESOLVED AND THE PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE, PAIN AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TREATMENT RECEIVED FOR BLEEDING. ESSURE DEVICE WAS CANNULATED INTO EACH FALLOPIAN TUBE ORIFICE WITH 3 EXPOSED COILS NOTED ON THE RIGHT SIDE AND 2 EXPOSED COILS NOTED ON THE PATIENT'S LEFT SIDE. LOT NUMBER: 893029 MANUFACTURE DATE: 2011-08 EXPIRATION DATE: 2014-08. 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 24-MAY-2021: QUALITY SAFETY EVALUATION OF PTC. 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 PAIN ('PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893029) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSION, ANXIETY, BREAST CANCER, DYSFUNCTIONAL UTERINE BLEEDING, SEIZURE, MASTECTOMY BILATERAL, NASAL OPERATION, SEPTOPLASTY, CHEMOTHERAPY NOS, CEPHALGIA, OVARIAN CYST AND CERVICITIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: SUBOXONE AND EFFEXOR. CONCOMITANT PRODUCTS INCLUDED CLONAZEPAM, GABAPENTIN, TIZANIDINE AND VENLAFAXINE HYDROCHLORIDE (EFFEXOR). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") AND PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED ON (B)(6) 2019,HYSTERECTOMY + BI-S). ESSURE WAS REMOVED ON 31-JUL-2019. AT THE TIME OF THE REPORT, THE PAIN AND GENITAL HAEMORRHAGE HAD RESOLVED AND THE PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE, PAIN AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TREATMENT RECEIVED FOR BLEEDING. ESSURE DEVICE WAS CANNULATED INTO EACH FALLOPIAN TUBE ORIFICE WITH 3 EXPOSED COILS NOTED ON THE RIGHT SIDE AND 2 EXPOSED COILS NOTED ON THE PATIENT'S LEFT SIDE QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-MAY-2021: MR RECEIVED. REPORTER INFORMATION , PATIENT DETAILS , EXPIRATION DATE , OTHER RELEVANT HISTORY , CONCOMITANT DRUG ADDED AND RCC WAS UPDATED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PAIN ('PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893029) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSION, ANXIETY, BREAST CANCER, DYSFUNCTIONAL UTERINE BLEEDING, SEIZURE, MASTECTOMY BILATERAL, NASAL OPERATION, SEPTOPLASTY, CHEMOTHERAPY, CEPHALGIA, OVARIAN CYST AND CERVICITIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: SUBOXONE AND EFFEXOR. CONCOMITANT PRODUCTS INCLUDED CLONAZEPAM, GABAPENTIN, TIZANIDINE AND VENLAFAXINE HYDROCHLORIDE (EFFEXOR). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") AND PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED ON (B)(6) 2019,HYSTERECTOMY + BI-S). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PAIN AND GENITAL HAEMORRHAGE HAD RESOLVED AND THE PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE, PAIN AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TREATMENT RECEIVED FOR BLEEDING. ESSURE DEVICE WAS CANNULATED INTO EACH FALLOPIAN TUBE ORIFICE WITH 3 EXPOSED COILS NOTED ON THE RIGHT SIDE AND 2 EXPOSED COILS NOTED ON THE PATIENT'S LEFT SIDE QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: CCC CHANGED. AMENDMENT. DONE. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. 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 PAIN ('PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893029) 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 PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") AND PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED ON (B)(6) 2019, HYSTERECTOMY + BI-S). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PAIN AND GENITAL HAEMORRHAGE HAD RESOLVED AND THE PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE, PAIN AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TREATMENT RECEIVED FOR BLEEDING. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED: EVENT INJURY WAS UPDATED TO PAIN. NEW EVENT ABNORMAL BLEEDING AND PSYCH INJURY ADDED. OUTCOME OF EVENT PAIN AND ABNORMAL BLEEDING UPDATED TO RECOVERED. ESSURE REMOVAL DATE AND LOT NUMBER ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 549144 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 893029 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | CLONAZEPAM| CLONAZEPAM| CLONAZEPAM| EFFEXOR| EFFEXOR| EFFEXOR| GABAPENTIN| GABAPENTIN| GABAPENTIN| TIZANIDINE| TIZANIDINE| TIZANIDINE |