ESSURE
Report
- Report Number
- 2951250-2017-03162
- Event Type
- Injury
- Date Received
- August 22, 2017
- Date of Event
- April 1, 2014
- Report Date
- January 23, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN/ PELVIC PAIN") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (TERMINATION)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882481) 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" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II AND PARITY 3. CONCURRENT CONDITIONS INCLUDED VAGINAL DISCHARGE AND URINARY TRACT INFECTION. ON 4-APR-2014, THE PATIENT HAD ESSURE INSERTED. IN APRIL 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2014, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEPRESSION ("DEPRESSION") AND DYSMENORRHOEA ("HEAVY PAINFUL PERIODS"). 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 SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED IN OCTOBER 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, DEPRESSION, DYSMENORRHOEA AND FATIGUE OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED DEPRESSION, DYSMENORRHOEA, FATIGUE, PELVIC PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NEED FOR ADDITIONAL SURGERY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-SEP-2018: PFS AND MR RECEIVED. REPORTERS ADDED, LOT NUMBER ADDED. EVENTS ADDED AS:- PREGNANCY (TERMINATION), DEVICE INEFFECTIVE, DID NOT UNDERGO ESSURE CONFIRMATION TEST AND FATIGUE. INCIDENT AT THE TIME OF REPORTING, 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN/ PELVIC PAIN') AND PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY (TERMINATION)') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882481) 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" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED GALLBLADDER REMOVAL IN (B)(6) 2013, MULTIGRAVIDA AND PARITY 3. CONCURRENT CONDITIONS INCLUDED HUMAN PAPILLOMA VIRUS IMMUNISATION SINCE 2000, VAGINAL DISCHARGE, URINARY TRACT INFECTION, SEDATION AND URINATION PAIN. CONCOMITANT PRODUCTS INCLUDED HYDROXYZINE SINCE 2017. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA).") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)."). ON (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 1 YEAR 6 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"), DYSMENORRHOEA ("HEAVY PAINFUL PERIODS") AND FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED IN (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, FATIGUE AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE, DEPRESSION, DYSMENORRHOEA AND MENORRHAGIA 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 ELECTIVE ABORTION. THE REPORTER CONSIDERED DEPRESSION, DYSMENORRHOEA, FATIGUE, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NEED FOR ADDITIONAL SURGERY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-MAY-2019: PLAINTIFF FACT SHEET, NEW REPORTER, CONCURRENT CONDITION, ESSURE STOP DATE, CONCOMITANT MEDICATION AND EVENT ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) WERE 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION'), PELVIC PAIN ('PAIN/ PELVIC PAIN/ABDOMINAL'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY (TERMINATION)/ PREGNANCY: STILLBIRTH/MISCARRIAGE, BIRTH ¿ COMPLICATION') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING.') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882481) 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" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED GALLBLADDER REMOVAL IN (B)(6) 2013, MULTIGRAVIDA AND PARITY 3. CONCURRENT CONDITIONS INCLUDED HUMAN PAPILLOMA VIRUS IMMUNISATION SINCE 2000, VAGINAL DISCHARGE, URINARY TRACT INFECTION, SEDATION AND URINATION PAIN. CONCOMITANT PRODUCTS INCLUDED HYDROXYZINE SINCE 2017. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA).") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)."). ON (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 1 YEAR 6 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("DEPRESSION/PSY INJURY"), DYSMENORRHOEA ("HEAVY PAINFUL PERIODS"), FATIGUE ("FATIGUE"), ABDOMINAL PAIN ("PAIN: PELVIC/ABDOMINAL"), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URINARY TRACT INFECTION ("BLADDER/URINARY PROBLEMS: UTI, VAGINAL INFECTION") AND VAGINAL INFECTION ("BLADDER/URINARY PROBLEMS: UTI, VAGINAL INFECTION"). THE PATIENT WAS TREATED WITH SURGERY (HYST. (FULL) AND TO REMOVE THE ESSURE IMPLANT, { HYST. (FULL) }). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, DEPRESSION AND MENORRHAGIA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, DYSMENORRHOEA, FATIGUE, VAGINAL HAEMORRHAGE, ABDOMINAL PAIN, GENITAL HAEMORRHAGE, URINARY TRACT INFECTION AND VAGINAL INFECTION HAD RESOLVED. 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, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NEED FOR ADDITIONAL SURGERY. NO ADDITIONAL CASE WAS CREATED (IN THE PREVIOUS PFS, JUST ONE PREGNANCY WAS CLAIMED AND NOW, WE DO NOT HAVE ENOUGH INFORMATION TO ASSUME ANOTHER PREGNANCY) AND PREGNANCY WITH COMPLICATION WAS REPORTED BUT IT WAS NOT SPECIFIED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2018: ESSURE CONFIRMATION TEST(S) (UNSPECIFIED) LEFT OCCLUSION ONLY, MIGRATION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-SEP-2019: PFS RECEIVED : NEW EVENTS ADDED : " ABDOMINAL PAIN, GENERAL ABNORMAL BLEEDING, MIGRATION , BLADDER/URINARY PROBLEMS: UTI, VAGINAL INFECTION". OUTCOME OF EVENTS, "PELVIC/ABDOMINAL PAIN, GENERAL ABNORMAL BLEEDING,FATIGUE, BLADDER/URINARY PROBLEMS: UTI, VAGINAL INFECTION" WERE CHANGED TO "RECOVERED/RESOLVED".REPORTER CONTACT INFORMATION WAS ADDED. PATIENT'S DEMOGRAPHICS WERE ADDED. PRODUCT INDICATION UPDATED. LAB DATA WAS ADDED. WE RECEIVED A LOT NUMBER N 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 DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: COIL MIGRATED OUTSIDE THE FALLOPIAN TUBE') AND PELVIC PAIN ('PAIN/ PELVIC PAIN/ABDOMINAL') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882481) 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" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED GALLBLADDER REMOVAL IN (B)(6)2013, MULTIGRAVIDA AND PARITY 3. CONCURRENT CONDITIONS INCLUDED HUMAN PAPILLOMA VIRUS IMMUNISATION SINCE 2000, VAGINAL DISCHARGE, URINARY TRACT INFECTION, SEDATION AND URINATION PAIN. CONCOMITANT PRODUCTS INCLUDED HYDROXYZINE SINCE 2017. ON (B)(6)2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FATIGUE ("FATIGUE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA).") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)."). IN (B)(6)2014, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION/PSY INJURY"), URINARY TRACT INFECTION ("BLADDER/URINARY PROBLEMS: UTI, VAGINAL INFECTION"), VAGINAL INFECTION ("BLADDER/URINARY PROBLEMS: UTI, VAGINAL INFECTION"), ANXIETY ("MENTAL ANGUISH"), NAUSEA ("NAUSEA") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6)2015, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (TERMINATION)/ PREGNANCY: STILLBIRTH/MISCARRIAGE, BIRTH ¿ COMPLICATION"), 1 YEAR 6 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6)2018, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("HEAVY PAINFUL PERIODS"), ABDOMINAL PAIN ("PAIN: PELVIC/ABDOMINAL") AND GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING."). THE PATIENT WAS TREATED WITH SURGERY (HYST. (FULL) AND TO REMOVE THE ESSURE IMPLANT, { HYST. (FULL) }). ESSURE WAS REMOVED ON (B)(6)2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, DEPRESSION, MENORRHAGIA, ANXIETY, NAUSEA AND DYSPAREUNIA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, DYSMENORRHOEA, FATIGUE, VAGINAL HAEMORRHAGE, ABDOMINAL PAIN, GENITAL HAEMORRHAGE, URINARY TRACT INFECTION AND VAGINAL INFECTION HAD RESOLVED. 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, ANXIETY, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NEED FOR ADDITIONAL SURGERY. NO ADDITIONAL CASE WAS CREATED (IN THE PREVIOUS PFS, JUST ONE PREGNANCY WAS CLAIMED AND NOW, WE DO NOT HAVE ENOUGH INFORMATION TO ASSUME ANOTHER PREGNANCY)AND PREGNANCY WITH COMPLICATION WAS REPORTED BUT IT WAS NOT SPECIFIED. DISCREPANCY: IN CURRENT SOURCE DOCUMENT PATIENTS REPORTED- HAVE YOU HAD YOUR ESSURE REMOVED-NO (PER PFS) & IN PREVIOUS CASE DATE OF REMOVAL WAS NOTED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2018: RESULT: UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED). MIGRATION OF ESSURE DEVICE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-JAN-2020: PFS RECEIVED: REPORTERS WERE ADDED. NEW EVENT- MENTAL ANGUISH, NAUSEA, DYSPAREUNIA WERE ADDED. LAB TEST WAS 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 PELVIC PAIN ("PAIN/ PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("DEPRESSION") AND DYSMENORRHOEA ("HEAVY PAINFUL PERIODS"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT .). ESSURE WAS REMOVED IN (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEPRESSION AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEPRESSION, DYSMENORRHOEA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NEED FOR ADDITIONAL SURGERY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-NOV-2017: FOLLOW UP FROM SUMMONS RECEIVED-EVENTS DEPRESSION, HEAVY PAINFUL PERIODS WERE ADDED AND PELVIC PAIN WAS CLUBBED WITH PREVIOUSLY REPORTED EVENT. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE THE ESSURE IMPLANT IN (B)(6) 2015.). ESSURE WAS REMOVED IN (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE. 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 |
|---|---|---|---|---|---|---|---|
| 591492 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 882481 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Other| R | HYDROXYZINE| HYDROXYZINE| HYDROXYZINE |