ESSURE
Report
- Report Number
- 2951250-2019-02004
- Event Type
- Injury
- Date Received
- May 21, 2019
- Report Date
- March 11, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ('LEFT ESSURE WAS IN THE MYOMETRIUM/ CLAIMING PERFORATION: UTERUS/ MALPOSITION OF ESSURE DEVICE/ PERFORATION (UTERUS)'), FALLOPIAN TUBE PERFORATION ('CLAIMING PERFORATION: FALLOPIAN TUBE/ MALPOSITION OF ESSURE DEVICE') AND ABORTION SPONTANEOUS ('PREGNANCY- STILLBIRTH/MISCARRIAGE') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872990) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED RECURRENT ABORTION (B)(6)2014, (B)(6)2013, (B)(6)2012, TWO DATES NOT PROVIDED.)). ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT"), 7 DAYS AFTER INSERTION OF ESSURE. IN (B)(6)2012, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY- STILLBIRTH/MISCARRIAGE"). ON (B)(6) 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). IN (B)(6)2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6)2014, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6)2018, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN FEMLAE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), OVARIAN CYST ("TUMOR TERATOMA/ CANCER TYPE: OVARIAN CYST"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: UNKNOWN UNTIL ENDOSCOPY"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND PELVIC INFLAMMATORY DISEASE ("PELVIC INFLAMMATORY DISEASE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2018. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, FALLOPIAN TUBE PERFORATION, ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, BACK PAIN, DYSPAREUNIA, MOOD SWINGS, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, BLADDER DISORDER, OVARIAN CYST, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, GASTROINTESTINAL DISORDER, ALOPECIA, URINARY TRACT DISORDER AND PELVIC INFLAMMATORY DISEASE OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, DEPRESSION AND NAUSEA WAS RESOLVING. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 9, PARA 2. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, ALOPECIA, BACK PAIN, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, GASTROINTESTINAL DISORDER, MENORRHAGIA, MOOD SWINGS, NAUSEA, OVARIAN CYST, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE WERE 10 COILS ON THE LEFT OSTIA AND :3 COILS ON THE RIGHT OSTIA SEEN ONE MISCARRIAGE BEFORE ESSURE PLACEMENT SIX MISCARRIAGES AFTER ESSURE PLACEMENT THE PLAINTIFF EXPERIENCED ADDITIONAL 5 MISCARRIAGES POST ESSURE PLACEMENT WHICH HAVE BEEN CAPTURED UNDER CASE NUMBER 2020-027378 (02/2012), 2020-027381 (11/2013), 2020-027382 (01/2014) , 2020-027383(PREGNANCY DATE NOT PROVIDED), 2020-027384 ((PREGNANCY DATE NOT PROVIDED). THIS CASE CONCERNS PREGNANCY DATED 04/2014. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN - ON AN UNKNOWN DATE: LEFT ESSURE WAS IN THE MYOMETRIUM OR OTHERWISE DISPLACED AND THAT THE RIGHT ESSURE WAS IN THE APPROPRIATE PLACE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JAN-2020: PLAINTIFF FACT SHEET RECEIVED : REPORTER INFORMATION EVENTS ADDED- EVENTS ADDED- HORMONAL CHANGES DESCRIBE: MOOD SWINGS, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION, BLADDER OR URINARY PROBLEMS OR CHANGES, NAUSEA, TUMOR TERATOMA/ CANCER TYPE: OVARIAN CYST, VAGINAL DISCHARGE, FATIGUE, WEIGHT GAIN, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: UNKNOWN UNTIL ENDOSCOPY, HAIR LOSS, PELVIC INFLAMMATORY DISEASE. 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 UTERINE PERFORATION ('LEFT ESSURE WAS IN THE MYOMETRIUM/ CLAIMING PERFORATION: UTERUS/ MALPOSITION OF ESSURE DEVICE/ PERFORATION (UTERUS)'), FALLOPIAN TUBE PERFORATION ('CLAIMING PERFORATION: FALLOPIAN TUBE/ MALPOSITION OF ESSURE DEVICE') AND ABORTION SPONTANEOUS ('PREGNANCY- STILLBIRTH/MISCARRIAGE') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872990) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED RECURRENT ABORTION (((B)(6) 2014, (B)(6) 2013, (B)(6) 2012, TWO DATES NOT PROVIDED.)). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT"), 7 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY- STILLBIRTH/MISCARRIAGE"). ON (B)(6) 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2018, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN FEMLAE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), OVARIAN CYST ("TUMOR TERATOMA/ CANCER TYPE: OVARIAN CYST"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: UNKNOWN UNTIL ENDOSCOPY"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND PELVIC INFLAMMATORY DISEASE ("PELVIC INFLAMMATORY DISEASE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, FALLOPIAN TUBE PERFORATION, ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, BACK PAIN, DYSPAREUNIA, MOOD SWINGS, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, BLADDER DISORDER, OVARIAN CYST, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, GASTROINTESTINAL DISORDER, ALOPECIA, URINARY TRACT DISORDER AND PELVIC INFLAMMATORY DISEASE OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, DEPRESSION AND NAUSEA WAS RESOLVING. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 9, PARA 2. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, ALOPECIA, BACK PAIN, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, GASTROINTESTINAL DISORDER, MENORRHAGIA, MOOD SWINGS, NAUSEA, OVARIAN CYST, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE WERE 10 COILS ON THE LEFT OSTIA AND :3 COILS ON THE RIGHT OSTIA SEEN ONE MISCARRIAGE BEFORE ESSURE PLACEMENT SIX MISCARRIAGES AFTER ESSURE PLACEMENT THE PLAINTIFF EXPERIENCED ADDITIONAL 5 MISCARRIAGES POST ESSURE PLACEMENT WHICH HAVE BEEN CAPTURED UNDER CASE NUMBER (B)(4) ((B)(6) 2012), (B)(4) ((B)(6) 2013), (B)(4) ((B)(6) 2014) , (B)(4) (PREGNANCY DATE NOT PROVIDED), (B)(4) ((PREGNANCY DATE NOT PROVIDED). THIS CASE CONCERNS PREGNANCY DATED (B)(6) 2014. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN - ON AN UNKNOWN DATE: LEFT ESSURE WAS IN THE MYOMETRIUM OR OTHERWISE DISPLACED AND THAT THE RIGHT ESSURE WAS IN THE APPROPRIATE PLACE. LOT NUMBER: 872990 MANUFACTURING DATE: 2011-06 EXPIRATION DATE: 2014-06. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-MAR-2020: 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 EMBEDDED DEVICE ('LEFT ESSURE WAS IN THE MYOMETRIUM') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872990) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEVICE EXPULSION ("LEFT ESSURE WAS IN THE MYOMETRIUM"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE AND DEVICE EXPULSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE EXPULSION AND EMBEDDED DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE WERE 10 COILS ON THE LEFT OSTIA AND :3 COILS ON THE RIGHT OSTIA SEEN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN - ON AN UNKNOWN DATE: LEFT ESSURE WAS IN THE MYOMETRIUM OR OTHERWISE DISPLACED AND THAT THE RIGHT ESSURE WAS IN THE APPROPRIATE PLACE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT: 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ('LEFT ESSURE WAS IN THE MYOMETRIUM/ CLAIMING PERFORATION: UTERUS'), FALLOPIAN TUBE PERFORATION ('CLAIMING PERFORATION: FALLOPIAN TUBE'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY- STILLBIRTH/MISCARRIAGE') AND ABORTION SPONTANEOUS ('PREGNANCY- STILLBIRTH/MISCARRIAGE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872990) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN FEMLAE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), BACK PAIN ("BACK PAIN") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE).") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, FALLOPIAN TUBE PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN AND DYSPAREUNIA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND UTERINE PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE WERE 10 COILS ON THE LEFT OSTIA AND :3 COILS ON THE RIGHT OSTIA SEEN DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN - ON AN UNKNOWN DATE: LEFT ESSURE WAS IN THE MYOMETRIUM OR OTHERWISE DISPLACED AND THAT THE RIGHT ESSURE WAS IN THE APPROPRIATE PLACE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS RECEIVED. REPORTERS INFORMATION UPDATED. EVENT: PELVIC PAIN , ABDOMINAL PAIN, BACK PAIN , DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE) , PREGNANCY- STILLBIRTH/MISCARRIAGE , DEVICE INEFFECTIVE AND FALLOPIAN TUBE WERE ADDED AND EMBEDMENT/ EXPULSION WERE CLUBBED WITH 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ('LEFT ESSURE WAS IN THE MYOMETRIUM') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872990) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEVICE EXPULSION ("LEFT ESSURE WAS IN THE MYOMETRIUM"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE AND DEVICE EXPULSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE EXPULSION AND EMBEDDED DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE WERE 10 COILS ON THE LEFT OSTIA AND :3 COILS ON THE RIGHT OSTIA SEEN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN - ON AN UNKNOWN DATE: LEFT ESSURE WAS IN THE MYOMETRIUM OR OTHERWISE DISPLACED AND THAT THE RIGHT ESSURE WAS IN THE APPROPRIATE PLACE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-MAY-2019: PFS RECEIVED- PREVIOUSLY REPORTED EVENT "INJURY TO HERSELF " UPDATED TO "LEFT ESSURE WAS IN THE MYOMETRIUM", EVENT "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST", REPORTER, LOT NUMBER, LAB DATA ADDED. INCIDENT: 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 420368 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 872990 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other| R |