ESSURE
Report
- Report Number
- 2951250-2017-08706
- Event Type
- Injury
- Date Received
- November 24, 2017
- Date of Event
- November 19, 2012
- Report Date
- August 25, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- 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 PELVIC PAIN ('PAIN THAT I WAS HAVING/PELVIS LABOR PAIN/I NOTICED A DECREASE IN PAIN A FEW WEEKS AFTER ESSURE REMOVAL'), ADENOMYOSIS ('ADENOMYOSIS') AND ABORTION SPONTANEOUS ('ONE DIED EARLY IN PREGNANCY/I LOST ONE EARLY') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863570) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 2 AND ABORTION. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL AND DYSMENORRHEA. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORGESTIMATE (SPRINTEC)(B)(6)2014 TO (B)(6)2017 FOR CONTRACEPTION AS WELL AS SINCE 2014. ON(B)(6)2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PAIN UPON MOVEMENT ("SIDE PAIN/SIDE ACHING/SOME OF MY SIDE PAIN HAS DECREASED/ EVERY DAY PAIN FROM WALKING") AND ARTHRALGIA ("JOINT PAIN IN LEGS, ARMS ALL OVER"). ON (B)(6)-2012, THE PATIENT EXPERIENCED FLANK PAIN ("FLANK PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED BACK PAIN ("BACK PAIN 1 MONTH AFTER INSERTION IN 2012 THERAPY") AND PAIN IN EXTREMITY ("BACK/LEG STABBING/THE STABBING LEG PAIN HAS GOTTEN BETTER"). ON (B)(6)2014, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("I WAS PREGNANT WITH TWINS, HOWEVER, I LOST ONE EARLY ON AND DECIDED TO TERMINATE THE REMAINING FETUS/UNINTENDED PREGNANCY"). ON (B)(6)2015, THE PATIENT EXPERIENCED ABDOMINAL PAIN UPPER ("SEVERE AND PERSISTENT STOMACH PAIN/SIDE AND STOMACH PAIN"). ON (B)(6)2016, THE PATIENT EXPERIENCED MUSCULOSKELETAL PAIN ("MUSCULAR SKELETAL PAIN"). ON (B)(6)2017, THE PATIENT EXPERIENCED ADENOMYOSIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BIPOLAR DISORDER ("BI-POLAR/BI-POLAR OVER 5 YEAR PRESENT"), MENSTRUATION IRREGULAR ("CYCLE CHANGES"), DYSPAREUNIA ("PAIN WITH INTERCOURSE/I STILL EXPERIENCE SOME PAIN AND DISCOMFORT WITH INTERCOURSE/PAIN DURING INTERCOURSE"), ABDOMINAL PAIN LOWER ("CRAMPING"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), ANXIETY ("MENTAL ANGUISH/I HAVE ALSO EXPERIENCED MENTAL ANGUISH AND PAIN"), LIBIDO DECREASED ("INABILITY TO HAVE SEX/I WAS IN PAIN AND IT GREATLY AFFECTED OUR SEX LIFE") AND PAIN ("THE RIGHT SIDE OF MY BODY STILL HAS PAIN"). THE PATIENT WAS TREATED WITH MUSCLE RELAXANTS, PARACETAMOL (TYLENOL), AND SURGERY (LAPAROSCOPIC SUPRA CERVICAL HYSTERECTOMY; BILATERAL SALPINGECTOMY, OPERATIVE LAPAROSCOPY). ESSURE WAS REMOVED ON(B)(6)2017. IN 2017, THE PELVIC PAIN AND PAIN UPON MOVEMENT WAS RESOLVING. AT THE TIME OF THE REPORT, THE ADENOMYOSIS, BIPOLAR DISORDER, DYSPAREUNIA, ARTHRALGIA AND PAIN HAD NOT RESOLVED, THE ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, MENSTRUATION IRREGULAR, ABDOMINAL PAIN UPPER, ABDOMINAL PAIN LOWER, VAGINAL DISCHARGE, ANXIETY, MUSCULOSKELETAL PAIN, BACK PAIN, LIBIDO DECREASED AND FLANK PAIN OUTCOME WAS UNKNOWN AND THE PAIN IN EXTREMITY WAS RESOLVING. 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 ELECTIVE ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ABORTION SPONTANEOUS, ADENOMYOSIS, ANXIETY, ARTHRALGIA, BACK PAIN, BIPOLAR DISORDER, DYSPAREUNIA, FLANK PAIN, LIBIDO DECREASED, MENSTRUATION IRREGULAR, MUSCULOSKELETAL PAIN, PAIN IN EXTREMITY, PAIN UPON MOVEMENT, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL DISCHARGE AND PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.9 KG/SQM. UNDERGO AN ESSURE CONFIRMATION TEST APPROXIMATELY (B)(6)2013 INK DYE (B)(6)2017:SURGICAL PATHOLOGY REPORT: UTERUS AND BILATERAL FALLOPIAN TUBES, SUPRA CERVICAL MORCELLATED REMOVAL: ENDOMETRIUM: INACTIVE ENDOMETRIUM MYOMETRIUM: BENIGN LEIOMYOMAS. SEROSA: NO PATHOLOGIC CHANGE BILATERAL BENIGN FALLOPIAN TUBES WITH NO PATHOLOGIC CHANGE QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2020: QUALITY SAFETY EVALUATION OF PTC. 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 PELVIC PAIN ('PAIN THAT I WAS HAVING/PELVIS LABOR PAIN/I NOTICED A DECREASE IN PAIN A FEW WEEKS AFTER ESSURE REMOVAL'), ADENOMYOSIS ('ADENOMYOSIS') AND ABORTION SPONTANEOUS ('ONE DIED EARLY IN PREGNANCY/I LOST ONE EARLY') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863570) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 2 AND ABORTION. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL AND DYSMENORRHEA. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORGESTIMATE (SPRINTEC) (B)(6) 2014 TO (B)(6) 2017 FOR CONTRACEPTION AS WELL AS SINCE 2014. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PAIN UPON MOVEMENT ("SIDE PAIN/SIDE ACHING/SOME OF MY SIDE PAIN HAS DECREASED/ EVERY DAY PAIN FROM WALKING") AND ARTHRALGIA ("JOINT PAIN IN LEGS, ARMS ALL OVER"). ON (B)(6) 2012, THE PATIENT EXPERIENCED FLANK PAIN ("FLANK PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED BACK PAIN ("BACK PAIN 1 MONTH AFTER INSERTION IN 2012 THERAPY") AND PAIN IN EXTREMITY ("BACK/LEG STABBING/THE STABBING LEG PAIN HAS GOTTEN BETTER"). ON (B)(6) 2014, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("I WAS PREGNANT WITH TWINS, HOWEVER, I LOST ONE EARLY ON AND DECIDED TO TERMINATE THE REMAINING FETUS/UNINTENDED PREGNANCY"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ABDOMINAL PAIN UPPER ("SEVERE AND PERSISTENT STOMACH PAIN/SIDE AND STOMACH PAIN"). ON (B)(6) 2016, THE PATIENT EXPERIENCED MUSCULOSKELETAL PAIN ("MUSCULAR SKELETAL PAIN"). ON (B)(6) 2017, THE PATIENT EXPERIENCED ADENOMYOSIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BIPOLAR DISORDER ("BI-POLAR/BI-POLAR OVER 5 YEAR PRESENT"), MENSTRUATION IRREGULAR ("CYCLE CHANGES"), DYSPAREUNIA ("PAIN WITH INTERCOURSE/I STILL EXPERIENCE SOME PAIN AND DISCOMFORT WITH INTERCOURSE/PAIN DURING INTERCOURSE"), ABDOMINAL PAIN LOWER ("CRAMPING"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), ANXIETY ("MENTAL ANGUISH/I HAVE ALSO EXPERIENCED MENTAL ANGUISH AND PAIN"), LIBIDO DECREASED ("INABILITY TO HAVE SEX/I WAS IN PAIN AND IT GREATLY AFFECTED OUR SEX LIFE") AND PAIN ("THE RIGHT SIDE OF MY BODY STILL HAS PAIN"). THE PATIENT WAS TREATED WITH MUSCLE RELAXANTS, PARACETAMOL (TYLENOL), AND SURGERY (LAPAROSCOPIC SUPRA CERVICAL HYSTERECTOMY; BILATERAL SALPINGECTOMY, OPERATIVE LAPAROSCOPY). ESSURE WAS REMOVED ON (B)(6) 2017. IN 2017, THE PELVIC PAIN AND PAIN UPON MOVEMENT WAS RESOLVING. AT THE TIME OF THE REPORT, THE ADENOMYOSIS, BIPOLAR DISORDER, DYSPAREUNIA, ARTHRALGIA AND PAIN HAD NOT RESOLVED, THE ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, MENSTRUATION IRREGULAR, ABDOMINAL PAIN UPPER, ABDOMINAL PAIN LOWER, VAGINAL DISCHARGE, ANXIETY, MUSCULOSKELETAL PAIN, BACK PAIN, LIBIDO DECREASED AND FLANK PAIN OUTCOME WAS UNKNOWN AND THE PAIN IN EXTREMITY WAS RESOLVING. 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 ELECTIVE ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ABORTION SPONTANEOUS, ADENOMYOSIS, ANXIETY, ARTHRALGIA, BACK PAIN, BIPOLAR DISORDER, DYSPAREUNIA, FLANK PAIN, LIBIDO DECREASED, MENSTRUATION IRREGULAR, MUSCULOSKELETAL PAIN, PAIN IN EXTREMITY, PAIN UPON MOVEMENT, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL DISCHARGE AND PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.9 KG/SQM. UNDERGO AN ESSURE CONFIRMATION TEST APPROXIMATELY (B)(6) 2013 INK DYE. (B)(6) 2017:SURGICAL PATHOLOGY REPORT: UTERUS AND BILATERAL FALLOPIAN TUBES, SUPRA CERVICAL MORCELLATED REMOVAL: ENDOMETRIUM: INACTIVE ENDOMETRIUM MYOMETRIUM: BENIGN LEIOMYOMAS. SEROSA: NO PATHOLOGIC CHANGE BILATERAL BENIGN FALLOPIAN TUBES WITH NO PATHOLOGIC CHANGE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-JUL-2020: MR RECEIVED : REPORTER ADDED, LOT NUMBER 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN THAT I WAS HAVING/PELVIS LABOR PAIN/I NOTICED A DECREASE IN PAIN A FEW WEEKS AFTER ESSURE REMOVAL"), ADENOMYOSIS ("ADENOMYOSIS"), ABORTION SPONTANEOUS ("ONE DIED EARLY IN PREGNANCY/I LOST ONE EARLY"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("I WAS PREGNANT WITH TWINS, HOWEVER, I LOST ONE EARLY ON AND DECIDED TO TERMINATE THE REMAINING FETUS/UNINTENDED PREGNANCY") AND BIPOLAR DISORDER ("BI-POLAR/BI-POLAR OVER 5 YEAR PRESENT") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 2 AND ABORTION. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED CILEST (SPRINTEC) ON (B)(6) 2014 FOR CONTRACEPTION AS WELL AS EUGYNON (LEVORA) IN 2014. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE FIRST EPISODE OF PAIN ("SIDE PAIN/SIDE ACHING/SOME OF MY SIDE PAIN HAS DECREASED/ EVERY DAY PAIN FROM WALKING") AND ARTHRALGIA ("JOINT PAIN IN LEGS, ARMS ALL OVER"). ON (B)(6) 2012, THE PATIENT EXPERIENCED FLANK PAIN ("FLANK PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED BACK PAIN ("BACK PAIN 1 MONTH AFTER INSERTION IN 2012 THERAPY") AND PAIN IN EXTREMITY ("BACK/LEG STABBING/THE STABBING LEG PAIN HAS GOTTEN BETTER"). ON (B)(6) 2014, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2015, THE PATIENT EXPERIENCED ABDOMINAL PAIN UPPER ("SEVERE AND PERSISTENT STOMACH PAIN/SIDE AND STOMACH PAIN"). ON (B)(6) 2016, THE PATIENT EXPERIENCED MUSCULOSKELETAL PAIN ("MUSCULAR SKELETAL PAIN"). ON (B)(6) 2017, THE PATIENT EXPERIENCED ADENOMYOSIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BIPOLAR DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUATION IRREGULAR ("CYCLE CHANGES"), DYSPAREUNIA ("PAIN WITH INTERCOURSE/I STILL EXPERIENCE SOME PAIN AND DISCOMFORT WITH INTERCOURSE/PAIN DURING INTERCOURSE"), ABDOMINAL PAIN LOWER ("CRAMPING"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), ANXIETY ("MENTAL ANGUISH/I HAVE ALSO EXPERIENCED MENTAL ANGUISH AND PAIN"), LIBIDO DECREASED ("INABILITY TO HAVE SEX/I WAS IN PAIN AND IT GREATLY AFFECTED OUR SEX LIFE") AND THE SECOND EPISODE OF PAIN ("THE RIGHT SIDE OF MY BODY STILL HAS PAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH IBUPROFEN (MOTRIN), PARACETAMOL (TYLENOL), MUSCLE RELAXANTS, SURGERY (LAPAROSCOPIC HYSTERECTOMY SURGERY) AND SURGERY (ON(B)(6) 2017 PARTIAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. IN 2017, THE PELVIC PAIN WAS RESOLVING. AT THE TIME OF THE REPORT, THE ADENOMYOSIS, BIPOLAR DISORDER, DYSPAREUNIA, ARTHRALGIA AND THE LAST EPISODE OF PAIN HAD NOT RESOLVED, THE ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, MENSTRUATION IRREGULAR, ABDOMINAL PAIN UPPER, ABDOMINAL PAIN LOWER, VAGINAL DISCHARGE, ANXIETY, MUSCULOSKELETAL PAIN, BACK PAIN, LIBIDO DECREASED AND FLANK PAIN OUTCOME WAS UNKNOWN AND THE PAIN IN EXTREMITY WAS RESOLVING. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ABORTION SPONTANEOUS, ADENOMYOSIS, ANXIETY, ARTHRALGIA, BACK PAIN, BIPOLAR DISORDER, DYSPAREUNIA, FLANK PAIN, LIBIDO DECREASED, MENSTRUATION IRREGULAR, MUSCULOSKELETAL PAIN, PAIN IN EXTREMITY, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL DISCHARGE, THE FIRST EPISODE OF PAIN AND THE SECOND EPISODE OF PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6) . UNDERGO AN ESSURE CONFIRMATION TEST APPROXIMATELY (B)(6) 2013 INK DYE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: FU RECEIVED BY PFS:CASE CATEGORY CHANGED FROM INVALID TO VALID SINCE EVENTS RECEIVED SUCH AS PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, BIPOLAR DISORDER, ABDOMINAL PAIN, MENSTRUATION IRREGULAR, PAIN, ADENOMYOSIS, ABDOMINAL PAIN UPPER, DYSPAREUNIA, ABDOMINAL PAIN LOWER, VAGINAL DISCHARGE, ANXIETY, MUSCULOSKELETAL PAIN, BACK PAIN, LIBIDO DECREASED, PAIN IN EXTREMITY, ABDOMINAL PAIN, ARTHRALGIA, FLANK PAIN, FLANK PAIN, FLANK PAIN, PAIN, PAIN, DEVICE INEFFECTIVE. EVENT "SEVERE AND PERMANENT INJURIES" DELETED. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, (B)(4) TO BAYER PHARMA (B)(4), AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 837005 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 863570 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other| R | LEVORA| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS| SPRINTEC| SPRINTEC| SPRINTEC |