ESSURE
Report
- Report Number
- 2951250-2019-06725
- Event Type
- Injury
- Date Received
- September 17, 2019
- Report Date
- April 30, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 821579-NOT VALID) INSERTED FOR FEMALE STERILIZATION. 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 AN ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED C-SECTION IN 2013, MISCARRIAGE IN 2011, ELECTIVE ABORTION IN 2008, MULTIGRAVIDA, PARITY 4 (ON (B)(6) 1988,(B)(6) 2003,(B)(6) 2013 AND (B)(6) 2018) AND PREMATURE DELIVERY. ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY: YES. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED URTICARIA ("RASH,AND MENTAL ANGUISH, RASHES OR SKIN CONDITIONS TYPE: HIVES,"), DEPRESSION ("PSYCH INJURY,PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)"), 8 MONTHS 9 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), SKIN DISORDER ("SKIN CONDITION") AND BACK INJURY ("LOWER BACK,LOWER BACK INJURY") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY: BIRTH - NO COMPLICATION"). THE PATIENT WAS TREATED WITH ACETYLSALICYLIC ACID;CARISOPRODOL (SOMA CMPD), GABAPENTIN (NEURONTIN), HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), TRAMADOL AND SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, URTICARIA AND SKIN DISORDER HAD RESOLVED AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE, DEPRESSION, VAGINAL HAEMORRHAGE, MENORRHAGIA, ANXIETY AND BACK INJURY 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, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK INJURY, DEPRESSION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, SKIN DISORDER, URTICARIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON AN UNKNOWN DATE: RESULT NOT PROVIDED. LOT NUMBER 821579 IS NOT VALID . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-FEB-2020: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 821579-NOT VALID) INSERTED FOR FEMALE STERILIZATION. 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 AN ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED C-SECTION IN 2018, C-SECTION IN 2013, MISCARRIAGE IN 2011, ELECTIVE ABORTION IN 2008, MULTIGRAVIDA, PARITY 4 (ON (B)(6) 1988,(B)(6) 2003, 2013 AND (B)(6) 2018.1) AND PREMATURE DELIVERY. ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY: YES. CONCURRENT CONDITIONS INCLUDED LOW BACK PAIN AND LEG PAIN. CONCOMITANT PRODUCTS INCLUDED AMLODIPINE AND DIPHENHYDRAMINE HYDROCHLORIDE. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED URTICARIA ("RASH,AND MENTAL ANGUISH, RASHES OR SKIN CONDITIONS TYPE: HIVES,"), DEPRESSION ("PSYCH INJURY,PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)"), 8 MONTHS 9 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), SKIN DISORDER ("SKIN CONDITION") AND BACK INJURY ("LOWER BACK,LOWER BACK INJURY") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY: BIRTH - NO COMPLICATION/POST-IMPLANT PREGNANCY"). THE PATIENT WAS TREATED WITH ACETYLSALICYLIC ACID;CARISOPRODOL (SOMA CMPD), GABAPENTIN (NEURONTIN), HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), TRAMADOL AND SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, URTICARIA AND SKIN DISORDER HAD RESOLVED AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE, DEPRESSION, VAGINAL HAEMORRHAGE, MENORRHAGIA, ANXIETY AND BACK INJURY 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, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK INJURY, DEPRESSION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, SKIN DISORDER, URTICARIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON AN UNKNOWN DATE: RESULT NOT PROVIDED. LOT NUMBER 821579 IS NOT VALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-APR-2021: MEDICAL RECORD RECEIVED. REPORTERS INFORMATION, CONCOMITANT DRUGS, AND MEDICAL HISTORY WERE ADDED. THERE WAS NO SIGNIFICANT CHANGE IN THE MEDICAL CONTEXT OF CASE. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 821579) INSERTED FOR FEMALE STERILIZATION. 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 AN ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED C-SECTION IN 2013, MISCARRIAGE IN 2011, ELECTIVE ABORTION IN 2008, MULTIGRAVIDA, PARITY 4 (ON (B)(6) 1988, (B)(6) 2003, (B)(6) 2013 AND (B)(6) 2018.1) AND PREMATURE DELIVERY. ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY: YES. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED URTICARIA ("RASH,AND MENTAL ANGUISH, RASHES OR SKIN CONDITIONS TYPE: HIVES,"), DEPRESSION ("PSYCH INJURY,PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)"), 8 MONTHS 9 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), SKIN DISORDER ("SKIN CONDITION") AND BACK INJURY ("LOWER BACK,LOWER BACK INJURY") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY: BIRTH - NO COMPLICATION"). THE PATIENT WAS TREATED WITH ACETYLSALICYLIC ACID;CARISOPRODOL (SOMA CMPD), GABAPENTIN (NEURONTIN), HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), TRAMADOL AND SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, URTICARIA AND SKIN DISORDER HAD RESOLVED AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE, DEPRESSION, VAGINAL HAEMORRHAGE, MENORRHAGIA, ANXIETY AND BACK INJURY 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, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK INJURY, DEPRESSION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, SKIN DISORDER, URTICARIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON AN UNKNOWN DATE: RESULT NOT PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-JAN-2020: PLAINTIFF FACT SHEET RECEIVED, PATIENT DEMOGRAPHIC, PATIENT RELEVANT HISTORY AND TREATMENT MEDICATION ESSURE LOT NUMBER, EVENT ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), MENTAL ANGUISH , LOWER BACK INJURY AND SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST 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 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 PELVIC PAIN ('PELVIC PAIN') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 821579-INV) INSERTED FOR FEMALE STERILIZATION. 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 AN ESSURE CONFIRMATION TEST" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED C-SECTION IN 2013, MISCARRIAGE IN 2011, ELECTIVE ABORTION IN 2008, MULTIGRAVIDA, PARITY 4 (ON (B)(6) 1988, (B)(6) 2003, (B)(6) 2013 AND (B)(6) 2018.1) AND PREMATURE DELIVERY. ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY: YES. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED URTICARIA ("RASH,AND MENTAL ANGUISH, RASHES OR SKIN CONDITIONS TYPE: HIVES,"), DEPRESSION ("PSYCH INJURY,PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)"), 8 MONTHS 9 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), SKIN DISORDER ("SKIN CONDITION") AND BACK INJURY ("LOWER BACK,LOWER BACK INJURY") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY: BIRTH - NO COMPLICATION"). THE PATIENT WAS TREATED WITH ACETYLSALICYLIC ACID;CARISOPRODOL (SOMA CMPD), GABAPENTIN (NEURONTIN), HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), TRAMADOL AND SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, URTICARIA AND SKIN DISORDER HAD RESOLVED AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE, DEPRESSION, VAGINAL HAEMORRHAGE, MENORRHAGIA, ANXIETY AND BACK INJURY 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, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK INJURY, DEPRESSION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, SKIN DISORDER, URTICARIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON AN UNKNOWN DATE: RESULT NOT PROVIDED. LOT NUMBER 821579 IS INV. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-JAN-2020: UPDATE OF INFORMATION (BATCH IS INV). BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY: BIRTH - NO COMPLICATION') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". MEDICAL CONDITIONS: ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY: YES. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), RASH ("RASH"), SKIN DISORDER ("SKIN CONDITION") AND PSYCHOLOGICAL TRAUMA ("PSYCH INJURY") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, RASH AND SKIN DISORDER HAD RESOLVED AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE AND PSYCHOLOGICAL TRAUMA 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, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL PAIN, GENITAL HAEMORRHAGE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, PSYCHOLOGICAL TRAUMA, RASH AND SKIN DISORDER TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE ON AN UNKNOWN DATE: RESULT NOT PROVIDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-SEP-2019: PLAINTIFF FACT SHEET RECEIVED: EVENT INJURY WAS UPDATED TO EVENTS: PREGNANCY: BIRTH - NO COMPLICATION, PELVIC PAIN, ABDOMINAL PAIN, GENERAL ABNORMAL BLEEDING, RASH, SKIN CONDITION, PSYCH INJURY AND DEVICE INEFFECTIVE. ESSURE EXPLANT DATE ADDED. OUTCOME FOR EVENTS PELVIC PAIN, ABDOMINAL PAIN, GENERAL ABNORMAL BLEEDING, RASH AND SKIN CONDITION WERE ADDED. 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 |
|---|---|---|---|---|---|---|---|
| 871713 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 821579-NOT VALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other| R | AMLODIPINE| DIPHENHYDRAMINE HYDROCHLORIDE |