ESSURE
Report
- Report Number
- 2951250-2021-00735
- Event Type
- Injury
- Date Received
- March 10, 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 MEDICAL DEVICE REMOVAL ('FOREIGN-BODY MATERIAL HAS BEEN REMOVED') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 945067) INSERTED. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THAT AFTER THE TREATMENT, VARIOUS PHYSICAL SYMPTOMS HAVE DEVELOPED AND AS A RESULT OF THE SYMPTOMS, SHE IS HINDERED IN HER NORMAL DAILY FUNCTIONING AND SHE SUFFER DAMAGES. THE DATE OF INSERTION OF THE ESSURE HAS BEEN UPDATED FROM (B)(6) 2016 TO (B)(6) 2012. 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 16-MAR-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 FALLOPIAN TUBE PERFORATION ('MIGRATION OF THE ESSURE TO THE ABDOMINAL CAVITY PERFORATION OF FALLOPIAN TUBES AND OTHER ORGANS (AFTER MIGRATION);') AND PERFORATION ('PERFORATION OF OTHER ORGANS (AFTER MIGRATION)') 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: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), PERFORATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), ABDOMINAL PAIN ("SEVERE (CHRONIC) PAIN IN THE ABDOMEN"), BACK PAIN ("BACK PAIN"), ALLERGY TO METALS ("NICKEL ALLERGY"), HYPERSENSITIVITY ("ALLERGIC REACTION"), HEAVY MENSTRUAL BLEEDING ("ABNORMALLY LARGE AMOUNT OF BLOOD LOSS DURING MENSTRUATION"), MENSTRUAL DISORDER ("CHANGE IN MENSTRUATION CYCLE"), FALLOPIAN TUBE ENLARGEMENT ("SWELLINGS AND KINKS IN THE FALLOPIAN TUBES"), ABORTION SPONTANEOUS ("MISCARRIAGE"), HEADACHE ("HEAD PAIN"), PREMATURE MENOPAUSE ("PREMATURE MENOPAUSE"), ARTHRALGIA ("HIP PAIN"), FATIGUE ("EXTREME AND CHRONIC FATIGUE"), SKIN DISORDER ("SKIN PROBLEMS"), TOOTH DISORDER ("DENTAL PROBLEMS"), FEMALE SEXUAL DYSFUNCTION ("PROBLEMS WITH THE SEX LIFE"), MEDICAL DEVICE SITE CALCIFICATION ("SEVERE CALCIFICATION OF THE ESSURE IN THE FALLOPIAN TUBES;"), MOOD ALTERED ("MOOD CHANGES"), AMNESIA ("MEMORY LOSS"), MENTAL DISORDER ("PSYCHOLOGICAL PROBLEMS;"), DISTURBANCE IN ATTENTION ("CONCENTRATION PROBLEMS") AND PROCEDURAL COMPLICATION ("COMPLICATIONS IN CONNECTION WITH COMBINED ENDOMETRIUM ABLATION"), WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("UNDESIRED PREGNANCY") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF THE ESSURE, INCLUDING BOTH FALLOPIAN TUBES, OVARIES AND (OFTEN) (PARTS OF) THE UTERUS). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, PERFORATION, ABDOMINAL PAIN, BACK PAIN, ALLERGY TO METALS, HYPERSENSITIVITY, HEAVY MENSTRUAL BLEEDING, MENSTRUAL DISORDER, FALLOPIAN TUBE ENLARGEMENT, HEADACHE, HORMONE LEVEL ABNORMAL, ARTHRALGIA, FATIGUE, SKIN DISORDER, TOOTH DISORDER, MEDICAL DEVICE SITE CALCIFICATION, MOOD ALTERED, AMNESIA, MENTAL DISORDER AND DISTURBANCE IN ATTENTION HAD RESOLVED AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, PREMATURE MENOPAUSE AND PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, ALLERGY TO METALS, AMNESIA, ARTHRALGIA, BACK PAIN, DISTURBANCE IN ATTENTION, FALLOPIAN TUBE ENLARGEMENT, FALLOPIAN TUBE PERFORATION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, HEAVY MENSTRUAL BLEEDING, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, MEDICAL DEVICE SITE CALCIFICATION, MENSTRUAL DISORDER, MENTAL DISORDER, MOOD ALTERED, PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, PREMATURE MENOPAUSE, PROCEDURAL COMPLICATION, SKIN DISORDER AND TOOTH DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AFTER THE TREATMENT, VARIOUS PHYSICAL SYMPTOMS DEVELOPED AND AS A RESULT OF THE SYMPTOMS, SHE WAS HINDERED IN HER NORMAL DAILY FUNCTIONING AND SUFFERED DAMAGES. THE DATE OF INSERTION OF THE ESSURE WAS UPDATED FROM (B)(6) 2016 TO (B)(6) 2012. 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 26-MAY-2021: ABDOMINAL PAIN, ABORTION SPONTANEOUS, ALLERGY TO METALS, AMNESIA, ARTHALGIA, BACK PAIN, DISTURBANCE IN ATTENTION, FALLOPIAN TUBE ENLARGMENT, FALLOPIAN TUBE PERFORATION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, HEAVY MENTRUAL BLEEDING, HORMONE LEVAL ABNORMAL, HYPERSENSIBILITY, MEDICAL DEVICE SITE CALCIFICATION, MENSTRUAL DISORDER, MENTAL DISORDER, MOOD ALTERED, PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, PREMATURE MENOPAUSE, SKIN DISORDER, TOOTH DISORDER WERE 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 FALLOPIAN TUBE PERFORATION ('MIGRATION OF THE ESSURE TO THE ABDOMINAL CAVITY PERFORATION OF FALLOPIAN TUBES AND OTHER ORGANS (AFTER MIGRATION);') AND PERFORATION ('PERFORATION OF OTHER ORGANS (AFTER MIGRATION)') 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: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6)-2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), PERFORATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), ABDOMINAL PAIN ("SEVERE (CHRONIC) PAIN IN THE ABDOMEN"), BACK PAIN ("BACK PAIN"), ALLERGY TO METALS ("NICKEL ALLERGY"), HYPERSENSITIVITY ("ALLERGIC REACTION"), HEAVY MENSTRUAL BLEEDING ("ABNORMALLY LARGE AMOUNT OF BLOOD LOSS DURING MENSTRUATION"), MENSTRUAL DISORDER ("CHANGE IN MENSTRUATION CYCLE"), FALLOPIAN TUBE ENLARGEMENT ("SWELLINGS AND KINKS IN THE FALLOPIAN TUBES"), ABORTION SPONTANEOUS ("MISCARRIAGE"), HEADACHE ("HEAD PAIN"), PREMATURE MENOPAUSE ("PREMATURE MENOPAUSE"), ARTHRALGIA ("HIP PAIN"), FATIGUE ("EXTREME AND CHRONIC FATIGUE"), SKIN DISORDER ("SKIN PROBLEMS"), TOOTH DISORDER ("DENTAL PROBLEMS"), FEMALE SEXUAL DYSFUNCTION ("PROBLEMS WITH THE SEX LIFE"), MEDICAL DEVICE SITE CALCIFICATION ("SEVERE CALCIFICATION OF THE ESSURE IN THE FALLOPIAN TUBES;"), MOOD ALTERED ("MOOD CHANGES"), AMNESIA ("MEMORY LOSS"), MENTAL DISORDER ("PSYCHOLOGICAL PROBLEMS;"), DISTURBANCE IN ATTENTION ("CONCENTRATION PROBLEMS") AND PROCEDURAL COMPLICATION ("COMPLICATIONS IN CONNECTION WITH COMBINED ENDOMETRIUM ABLATION"), WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("UNDESIRED PREGNANCY") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF THE ESSURE, INCLUDING BOTH FALLOPIAN TUBES, OVARIES AND (OFTEN) (PARTS OF) THE UTERUS). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, PERFORATION, ABDOMINAL PAIN, BACK PAIN, ALLERGY TO METALS, HYPERSENSITIVITY, HEAVY MENSTRUAL BLEEDING, MENSTRUAL DISORDER, FALLOPIAN TUBE ENLARGEMENT, HEADACHE, HORMONE LEVEL ABNORMAL, ARTHRALGIA, FATIGUE, SKIN DISORDER, TOOTH DISORDER, MEDICAL DEVICE SITE CALCIFICATION, MOOD ALTERED, AMNESIA, MENTAL DISORDER AND DISTURBANCE IN ATTENTION HAD RESOLVED AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, PREMATURE MENOPAUSE AND PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, ALLERGY TO METALS, AMNESIA, ARTHRALGIA, BACK PAIN, DISTURBANCE IN ATTENTION, FALLOPIAN TUBE ENLARGEMENT, FALLOPIAN TUBE PERFORATION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, HEAVY MENSTRUAL BLEEDING, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, MEDICAL DEVICE SITE CALCIFICATION, MENSTRUAL DISORDER, MENTAL DISORDER, MOOD ALTERED, PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, PREMATURE MENOPAUSE, PROCEDURAL COMPLICATION, SKIN DISORDER AND TOOTH DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AFTER THE TREATMENT, VARIOUS PHYSICAL SYMPTOMS DEVELOPED AND AS A RESULT OF THE SYMPTOMS, SHE WAS HINDERED IN HER NORMAL DAILY FUNCTIONING AND SUFFERED DAMAGES. THE DATE OF INSERTION OF THE ESSURE WAS UPDATED FROM (B)(6)-2016 TO (B)(6)-2012. 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 (B)(6)-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 FALLOPIAN TUBE PERFORATION ('PERFORATION OF FALLOPIAN TUBES') AND UTERINE PERFORATION ('PERFORATION OF UTERUS') 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: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), ABDOMINAL PAIN ("SEVERE (CHRONIC) PAIN IN THE ABDOMEN/ PAIN"), DYSPAREUNIA ("DYSPAREUNIA"), BACK PAIN ("BACK PAIN"), HYPERSENSITIVITY ("ALLERGIC REACTION"), ALLERGY TO METALS ("NICKEL ALLERGY"), MENOMETRORRHAGIA ("ABNORMALLY LARGE AMOUNT OF BLOOD LOSS DURING MENSTRUATION/ ABNORMAL BLEEDING/ CHANGE IN MENSTRUATION CYCLE"), ABORTION SPONTANEOUS ("MISCARRIAGE"), FALLOPIAN TUBE ENLARGEMENT ("SWELLINGS AND KINKS IN THE FALLOPIAN TUBES"), MEDICAL DEVICE SITE CALCIFICATION ("SEVERE CALCIFICATION OF THE ESSURE IN THE FALLOPIAN TUBES"), HEADACHE ("HEAD PAIN"), ALOPECIA ("HAIR LOSS"), TOOTH DISORDER ("DENTAL PROBLEMS"), SKIN DISORDER ("SKIN PROBLEMS"), PREMATURE MENOPAUSE ("PREMATURE MENOPAUSE"), ARTHRALGIA ("HIP PAIN"), FATIGUE ("EXTREME AND CHRONIC FATIGUE"), FEMALE SEXUAL DYSFUNCTION ("PROBLEMS WITH THE SEX LIFE"), MOOD ALTERED ("MOOD CHANGES"), MENTAL DISORDER ("PSYCHOLOGICAL PROBLEMS") AND PROCEDURAL COMPLICATION ("COMPLICATIONS IN CONNECTION WITH COMBINED ENDOMETRIUM ABLATION"), WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("UNDESIRED PREGNANCY") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF THE ESSURE, INCLUDING BOTH FALLOPIAN TUBES, OVARIES AND (OFTEN) (PARTS OF) THE UTERUS). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, ABDOMINAL PAIN, BACK PAIN, HYPERSENSITIVITY, ALLERGY TO METALS, MENOMETRORRHAGIA, FALLOPIAN TUBE ENLARGEMENT, MEDICAL DEVICE SITE CALCIFICATION, HEADACHE, TOOTH DISORDER, SKIN DISORDER, HORMONE LEVEL ABNORMAL, ARTHRALGIA, FATIGUE, MOOD ALTERED AND MENTAL DISORDER HAD RESOLVED AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, PREMATURE MENOPAUSE AND PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, BACK PAIN, DYSPAREUNIA, FALLOPIAN TUBE ENLARGEMENT, FALLOPIAN TUBE PERFORATION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, HORMONE LEVEL ABNORMAL, MEDICAL DEVICE SITE CALCIFICATION, MENOMETRORRHAGIA, MENTAL DISORDER, MOOD ALTERED, PREGNANCY WITH CONTRACEPTIVE DEVICE, PREMATURE MENOPAUSE, PROCEDURAL COMPLICATION, SKIN DISORDER, TOOTH DISORDER AND UTERINE PERFORATION TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: AFTER THE TREATMENT, VARIOUS PHYSICAL SYMPTOMS DEVELOPED AND AS A RESULT OF THE SYMPTOMS, SHE WAS HINDERED IN HER NORMAL DAILY FUNCTIONING AND SUFFERED DAMAGES. THE DATE OF INSERTION OF THE ESSURE WAS UPDATED FROM (B)(6) 2016 TO (B)(6) 2012. NOTE: THE EVENTS REPORTED FOR THIS SPECIFIC PATIENT AT FOLLOW-UP OF (B)(6) 2022 SUBSTANTIALLY DIFFER (IN NUMBER AND TYPE OF EVENTS) FROM THOSE REPORTED ON (B)(6) 2021. AS PER CONSERVATIVE APPROACH, THE PREVIOUS EVENTS WERE KEPT IN THE EXPECTATION THAT PATIENT-SPECIFIC INFORMATION WILL BE OBTAINED IN THE COURSE OF FURTHER CASE DOCUMENTATION. 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 UTERUS", "HAIR LOSS", "DYSPAREUNIA" ADDED OR UPDATED AS EVENT. PERFORATION OF ORGAN(S) WAS DELETED DUE TO THE PATIENT-SPECIFIC LIST OF SYMPTOMS (FALLOPIAN AND UTERINE PERFORATION). 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 FALLOPIAN TUBE PERFORATION ('PERFORATION OF FALLOPIAN TUBES') AND UTERINE PERFORATION ('PERFORATION OF UTERUS') 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: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), ABDOMINAL PAIN ("SEVERE (CHRONIC) PAIN IN THE ABDOMEN/ PAIN"), DYSPAREUNIA ("DYSPAREUNIA"), BACK PAIN ("BACK PAIN"), HYPERSENSITIVITY ("ALLERGIC REACTION"), ALLERGY TO METALS ("NICKEL ALLERGY"), MENOMETRORRHAGIA ("ABNORMALLY LARGE AMOUNT OF BLOOD LOSS DURING MENSTRUATION/ ABNORMAL BLEEDING/ CHANGE IN MENSTRUATION CYCLE"), ABORTION SPONTANEOUS ("MISCARRIAGE"), FALLOPIAN TUBE ENLARGEMENT ("SWELLINGS AND KINKS IN THE FALLOPIAN TUBES"), MEDICAL DEVICE SITE CALCIFICATION ("SEVERE CALCIFICATION OF THE ESSURE IN THE FALLOPIAN TUBES"), HEADACHE ("HEAD PAIN"), ALOPECIA ("HAIR LOSS"), TOOTH DISORDER ("DENTAL PROBLEMS"), SKIN DISORDER ("SKIN PROBLEMS"), PREMATURE MENOPAUSE ("PREMATURE MENOPAUSE"), ARTHRALGIA ("HIP PAIN"), FATIGUE ("EXTREME AND CHRONIC FATIGUE"), FEMALE SEXUAL DYSFUNCTION ("PROBLEMS WITH THE SEX LIFE"), MOOD ALTERED ("MOOD CHANGES"), MENTAL DISORDER ("PSYCHOLOGICAL PROBLEMS") AND PROCEDURAL COMPLICATION ("COMPLICATIONS IN CONNECTION WITH COMBINED ENDOMETRIUM ABLATION"), WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("UNDESIRED PREGNANCY") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF THE ESSURE, INCLUDING BOTH FALLOPIAN TUBES, OVARIES AND (OFTEN) (PARTS OF) THE UTERUS). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, ABDOMINAL PAIN, BACK PAIN, HYPERSENSITIVITY, ALLERGY TO METALS, MENOMETRORRHAGIA, FALLOPIAN TUBE ENLARGEMENT, MEDICAL DEVICE SITE CALCIFICATION, HEADACHE, TOOTH DISORDER, SKIN DISORDER, HORMONE LEVEL ABNORMAL, ARTHRALGIA, FATIGUE, MOOD ALTERED AND MENTAL DISORDER HAD RESOLVED AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, PREMATURE MENOPAUSE AND PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, BACK PAIN, DYSPAREUNIA, FALLOPIAN TUBE ENLARGEMENT, FALLOPIAN TUBE PERFORATION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, MEDICAL DEVICE SITE CALCIFICATION, MENOMETRORRHAGIA, MENTAL DISORDER, MOOD ALTERED, PREGNANCY WITH CONTRACEPTIVE DEVICE, PREMATURE MENOPAUSE, PROCEDURAL COMPLICATION, SKIN DISORDER, TOOTH DISORDER AND UTERINE PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AFTER THE TREATMENT, VARIOUS PHYSICAL SYMPTOMS DEVELOPED AND AS A RESULT OF THE SYMPTOMS, SHE WAS HINDERED IN HER NORMAL DAILY FUNCTIONING AND SUFFERED DAMAGES. NOTE: THE EVENTS REPORTED FOR THIS SPECIFIC PATIENT AT FOLLOW-UP OF (B)(6) 2022 SUBSTANTIALLY DIFFER (IN NUMBER AND TYPE OF EVENTS) FROM THOSE REPORTED ON (B)(6) 2021. AS PER CONSERVATIVE APPROACH, THE PREVIOUS EVENTS WERE KEPT IN THE EXPECTATION THAT PATIENT-SPECIFIC INFORMATION WILL BE OBTAINED IN THE COURSE OF FURTHER CASE DOCUMENTATION. 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 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 MEDICAL DEVICE REMOVAL ('FOREIGN-BODY MATERIAL HAS BEEN REMOVED') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 945067) INSERTED. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THAT AFTER THE TREATMENT, VARIOUS PHYSICAL SYMPTOMS HAVE DEVELOPED AND AS A RESULT OF THE SYMPTOMS, SHE IS HINDERED IN HER NORMAL DAILY FUNCTIONING AND SHE SUFFER DAMAGES. THE DATE OF INSERTION OF THE ESSURE HAS BEEN UPDATED FROM (B)(6) 2016 TO (B)(6) 2012. 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 (B)(6)2021: THE ADVERSE EVENT INJURY HAS BEEN CHANGED TO MEDICAL DEVICE REMOVAL AND THE DATE OF THE INSERTION OF THE ESSURE HAS BEEN UPDATED. 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 |
|---|---|---|---|---|---|---|---|
| 351202 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 945067 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention| O |