ESSURE
Report
- Report Number
- 2951250-2019-07305
- Event Type
- Injury
- Date Received
- September 19, 2019
- Date of Event
- July 5, 2011
- Report Date
- July 9, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('CLAIMING PERFORATION:OTHER/CLAIMING MIGRATION/ FALLOPIAN TUBE PERFORATION'), DEVICE BREAKAGE ('CLAIMING BREAKAGE/ EXPULSION:BREAKAGE/BROKEN WIRE IN THE LEFT ABDOMEN AND PELVIS JUNCTION IS PRESENT') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841634-INV,822375) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "DOCTOR HAD TO DO A SECOND ATTEMPT ON THE RIGHT SIDE. FIRST TIME WAS NO POSSIBLE DUE TO TUBAL SPAMS." THE PATIENT'S MEDICAL HISTORY INCLUDED ASTHMA, CHLAMYDIAL INFECTION, GONORRHEA, YEAST INFECTION, CONSTIPATION, CERVICAL INTRAEPITHELIAL NEOPLASIA II, CESAREAN SECTION, HIGH CHOLESTEROL AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 9 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), ANXIETY ("MENTAL ANGUISH"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DEPRESSION ("PSYCH INJURY-DEPRESSION,"). ON (B)(6) 2011, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT UPPER ASPECT OF THE PELVIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND FALLOPIAN TUBE SPASM ("DOCTOR HAD TO DO A SECOND ATTEMPT ON THE RIGHT SIDE. FIRST TIME WAS NO POSSIBLE DUE TO TUBAL SPAMS."). THE PATIENT WAS TREATED WITH NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (ABLATION). ESSURE TREATMENT WAS ONGOING AT THE TIME OF THE REPORT. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, ANXIETY, VAGINAL HAEMORRHAGE, DEVICE DISLOCATION, DEPRESSION AND FALLOPIAN TUBE SPASM OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, FALLOPIAN TUBE SPASM, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN, BLEEDING, BREAKAGE & MIGRATION/PERFORATION. ESSURE REMOVAL NOT PLANNED AS PATIENT IS UNABLE TO AFFORD SURGERY INSERTION DETAILS- RIGHT- 3 COILS AND LEFT 1 COIL SEEN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON 30-SEP-2011: TOTAL BILATERAL OCCLUSION, BREAKAGE. LOT NUMBER (841634 ) IS INV. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-FEB-2020: 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 LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('CLAIMING PERFORATION:OTHER/CLAIMING MIGRATION/ FALLOPIAN TUBE PERFORATION'), DEVICE BREAKAGE ('CLAIMING BREAKAGE/ EXPULSION:BREAKAGE/BROKEN WIRE IN THE LEFT ABDOMEN AND PELVIS JUNCTION IS PRESENT') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841634-INV,822375,841534) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "DOCTOR HAD TO DO A SECOND ATTEMPT ON THE RIGHT SIDE. FIRST TIME WAS NO POSSIBLE DUE TO TUBAL SPAMS.". THE PATIENT'S MEDICAL HISTORY INCLUDED ASTHMA, CHLAMYDIAL INFECTION, GONORRHEA, YEAST INFECTION, CONSTIPATION, CERVICAL INTRAEPITHELIAL NEOPLASIA II, CESAREAN SECTION, HIGH CHOLESTEROL AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 9 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), ANXIETY ("MENTAL ANGUISH"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DEPRESSION ("PSYCH INJURY-DEPRESSION,"). ON (B)(6) 2011, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT UPPER ASPECT OF THE PELVIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND FALLOPIAN TUBE SPASM ("DOCTOR HAD TO DO A SECOND ATTEMPT ON THE RIGHT SIDE. FIRST TIME WAS NO POSSIBLE DUE TO TUBAL SPAMS."). THE PATIENT WAS TREATED WITH NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (ABLATION). ESSURE TREATMENT WAS ONGOING AT THE TIME OF THE REPORT. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, ANXIETY, VAGINAL HAEMORRHAGE, DEVICE DISLOCATION, DEPRESSION AND FALLOPIAN TUBE SPASM OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, FALLOPIAN TUBE SPASM, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN, BLEEDING, BREAKAGE & MIGRATION/PERFORATION. ESSURE REMOVAL NOT PLANNED AS PATIENT IS UNABLE TO AFFORD SURGERY. INSERTION DETAILS- RIGHT- 3 COILS AND LEFT 1 COIL SEEN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION, BREAKAGE. LOT NUMBER 841634 IS INV. LOT NUMBER: 822375, MANUFACTURE DATE: 2011-01, EXPIRATION DATE: 2014-01. LOT NUMBER: 841534, MANUFACTURE DATE: 2011-03, EXPIRATION DATE: 2014-03. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JUN-2020: 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 FALLOPIAN TUBE PERFORATION ('CLAIMING PERFORATION:OTHER/CLAIMING MIGRATION/ FALLOPIAN TUBE PERFORATION'), DEVICE BREAKAGE ('CLAIMING BREAKAGE/ EXPULSION:BREAKAGE/BROKEN WIRE IN THE LEFT ABDOMEN AND PELVIS JUNCTION IS PRESENT') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822375,841634) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "DOCTOR HAD TO DO A SECOND ATTEMPT ON THE RIGHT SIDE. FIRST TIME WAS NO POSSIBLE DUE TO TUBAL "SPASM".". THE PATIENT'S MEDICAL HISTORY INCLUDED ASTHMA, CHLAMYDIAL INFECTION, GONORRHEA, YEAST INFECTION, CONSTIPATION, CERVICAL INTRAEPITHELIAL NEOPLASIA II, CESAREAN SECTION, HIGH CHOLESTEROL AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 9 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), ANXIETY ("MENTAL ANGUISH"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DEPRESSION ("PSYCH INJURY-DEPRESSION,"). ON (B)(6) 2011, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT UPPER ASPECT OF THE PELVIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND FALLOPIAN TUBE SPASM ("DOCTOR HAD TO DO A SECOND ATTEMPT ON THE RIGHT SIDE. FIRST TIME WAS NO POSSIBLE DUE TO TUBAL "SPASM"."). THE PATIENT WAS TREATED WITH NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (ABLATION). ESSURE TREATMENT WAS ONGOING AT THE TIME OF THE REPORT. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, ANXIETY, VAGINAL HAEMORRHAGE, DEVICE DISLOCATION, DEPRESSION AND FALLOPIAN TUBE SPASM OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, FALLOPIAN TUBE SPASM, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN, BLEEDING, BREAKAGE & MIGRATION/PERFORATION. ESSURE REMOVAL NOT PLANNED AS PATIENT IS UNABLE TO AFFORD SURGERY INSERTION DETAILS- RIGHT- 3 COILS AND LEFT 1 COIL SEEN DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE: ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION, BREAKAGE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-JAN-2020: PFS+MR RECEIVED : LOT NUMBER ADDED. NEW EVENTS ABNORMAL BLEEDING (VAGINAL), MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT UPPER ASPECT OF THE PELVIS, MENTAL ANGUISH, DOCTOR HAD TO DO A SECOND ATTEMPT ON THE RIGHT SIDE. FIRST TIME WAS NO POSSIBLE DUE TO TUBAL "SPASM" WERE ADDED. EVENT PSYCH INJURY UPDATED TO DEPRESSION. EVENT PERFORATION UPDATED TO FALLOPIAN TUBE PERFORATION. NEW REPORTERS, HEIGHT, RACE, TREATMENT DRUG, MEDICAL HISTORY, CONCOMITANT DRUG ADDED. 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 FALLOPIAN TUBE PERFORATION ('CLAIMING PERFORATION:OTHER/CLAIMING MIGRATION/ FALLOPIAN TUBE PERFORATION'), DEVICE BREAKAGE ('CLAIMING BREAKAGE/ EXPULSION:BREAKAGE/BROKEN WIRE IN THE LEFT ABDOMEN AND PELVIS JUNCTION IS PRESENT') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841634-INV,822375) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "DOCTOR HAD TO DO A SECOND ATTEMPT ON THE RIGHT SIDE. FIRST TIME WAS NO POSSIBLE DUE TO TUBAL SPAMS.". THE PATIENT'S MEDICAL HISTORY INCLUDED ASTHMA, CHLAMYDIAL INFECTION, GONORRHEA, YEAST INFECTION, CONSTIPATION, CERVICAL INTRAEPITHELIAL NEOPLASIA II, CESAREAN SECTION, HIGH CHOLESTEROL AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 9 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), ANXIETY ("MENTAL ANGUISH"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DEPRESSION ("PSYCH INJURY-DEPRESSION,"). ON (B)(6) 2011, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT UPPER ASPECT OF THE PELVIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND FALLOPIAN TUBE SPASM ("DOCTOR HAD TO DO A SECOND ATTEMPT ON THE RIGHT SIDE. FIRST TIME WAS NO POSSIBLE DUE TO TUBAL SPAMS."). THE PATIENT WAS TREATED WITH NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (ABLATION). ESSURE TREATMENT WAS ONGOING AT THE TIME OF THE REPORT. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, ANXIETY, VAGINAL HAEMORRHAGE, DEVICE DISLOCATION, DEPRESSION AND FALLOPIAN TUBE SPASM OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, FALLOPIAN TUBE SPASM, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN, BLEEDING, BREAKAGE & MIGRATION/PERFORATION. ESSURE REMOVAL NOT PLANNED AS PATIENT IS UNABLE TO AFFORD SURGERY. INSERTION DETAILS- RIGHT- 3 COILS AND LEFT 1 COIL SEEN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION, BREAKAGE. LOT NUMBER (841634 ) IS INV. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-JAN-2020: UPDATE OF INFORMATION (BATCH IS INV). 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 FALLOPIAN TUBE PERFORATION ('CLAIMING PERFORATION:OTHER/CLAIMING MIGRATION/ FALLOPIAN TUBE PERFORATION'), DEVICE BREAKAGE ('CLAIMING BREAKAGE/ EXPULSION:BREAKAGE/BROKEN WIRE IN THE LEFT ABDOMEN AND PELVIS JUNCTION IS PRESENT') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841634-INV,822375,841534) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "DOCTOR HAD TO DO A SECOND ATTEMPT ON THE RIGHT SIDE. FIRST TIME WAS NO POSSIBLE DUE TO TUBAL SPAMS.". THE PATIENT'S MEDICAL HISTORY INCLUDED ASTHMA, CHLAMYDIAL INFECTION, GONORRHEA, YEAST INFECTION, CONSTIPATION, CERVICAL INTRAEPITHELIAL NEOPLASIA II, CESAREAN SECTION, HIGH CHOLESTEROL AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 9 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), ANXIETY ("MENTAL ANGUISH"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DEPRESSION ("PSYCH INJURY-DEPRESSION,"). ON (B)(6) 2011, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT UPPER ASPECT OF THE PELVIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND FALLOPIAN TUBE SPASM ("DOCTOR HAD TO DO A SECOND ATTEMPT ON THE RIGHT SIDE. FIRST TIME WAS NO POSSIBLE DUE TO TUBAL SPAMS."). THE PATIENT WAS TREATED WITH NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (ABLATION). ESSURE TREATMENT WAS ONGOING AT THE TIME OF THE REPORT. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, ANXIETY, VAGINAL HAEMORRHAGE, DEVICE DISLOCATION, DEPRESSION AND FALLOPIAN TUBE SPASM OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, FALLOPIAN TUBE SPASM, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN, BLEEDING, BREAKAGE & MIGRATION/PERFORATION. ESSURE REMOVAL NOT PLANNED AS PATIENT IS UNABLE TO AFFORD SURGERY INSERTION DETAILS- RIGHT- 3 COILS AND LEFT 1 COIL SEEN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION, BREAKAGE. LOT NUMBER (841634 ) IS INV. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED: NEW LOT NUMBER ADDED. ON 9-JAN-2020: NO NEW INFORMATION RECEIVED. 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 PERFORATION ('CLAIMING PERFORATION:OTHER/CLAIMING MIGRATION'), DEVICE BREAKAGE ('CLAIMING BREAKAGE/ EXPULSION:BREAKAGE') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN "), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"). ESSURE TREATMENT WAS ONGOING AT THE TIME OF THE REPORT. AT THE TIME OF THE REPORT, THE PERFORATION, DEVICE BREAKAGE, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE BREAKAGE, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, PERFORATION AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN, BLEEDING, BREAKAGE & MIGRATION/PERFORATION. ESSURE REMOVAL NOT PLANNED AS PATIENT IS UNABLE TO AFFORD SURGERY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE ON (B)(6) 2011: ESSURE CONFIRMATION TEST(S) BILATERAL OCCLUSION, BREAKAGE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS RECEIVED: PREVIOUSLY REPORTED EVENT INJURY WAS UPDATED TO NEW EVENTS CLAIMING MIGRATION, CLAIMING BREAKAGE/ EXPULSION: BREAKAGE, CLAIMING PERFORATION: OTHER, GENERAL ABNORMAL BLEEDING, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), PSYCH INJURY, INCIDENT. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 |
|---|---|---|---|---|---|---|---|
| 881129 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841634-INV,822375,841534 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other| R | DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA |