ESSURE
Report
- Report Number
- 2951250-2019-03100
- Event Type
- Injury
- Date Received
- June 27, 2019
- Report Date
- May 21, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ('THE SUCTION CURETTAGE WAS PERFORMED WITHOUT INCIDENT AFTER WHICH THE DIAGNOSTIC LAP WAS PERFORMED TO EVALUATE THE LOCATION OF THE PERFORATION. IT WAS ACTUALLY FOUND TO BE IN THE MID POSTERIOR ASPECT OF THE UTERUS AND WAS HAVING MINIMAL BLEEDING.') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822369) 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 OBESITY, MULTIGRAVIDA, PARITY 4 ((B)(6) 1998, (B)(6) 2000, (B)(6) 2003, (B)(6) 2006), OVARIAN CYSTECTOMY, UTERINE BLEEDING, RECURRENT ABORTION, ABORTION, PREGNANCY WITH CONTRACEPTIVE DEVICE ((B)(6) 2009 PREGNANCY (STILLBIRTH OR MISCARRIAGE)) AND ABORTION SPONTANEOUS ((B)(6) 2009 PREGNANCY (STILLBIRTH OR MISCARRIAGE)). CONCURRENT CONDITIONS INCLUDED GENITAL BLEEDING, CERVICITIS, NABOTHIAN CYST, ENDOCERVICAL SQUAMOUS METAPLASIA, ADENOMYOSIS, UTERINE BLEEDING, CHRONIC CERVICITIS, NABOTHIAN CYST AND ADENOMYOSIS. CONCOMITANT PRODUCTS INCLUDED KETOROLAC TROMETHAMINE (TORADOL), NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND PARACETAMOL (TYLENOL) SINCE (B)(6) 2009. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2009, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENOMETRORRHAGIA ("MENOMETRORRHAGIA"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH"), PELVIC PAIN ("PHYSICAL PAIN\ PAIN PELVIC AREA"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH") AND ANAEMIA ("BLOOD OR HEART DISORDER/CONDITION TYPE:ANEMIA"). ON (B)(6) 2010, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (STILLBIRTH OR MISCARRIAGE)"), 1 YEAR 3 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABORTION SPONTANEOUS ("PREGNANCY (STILLBIRTH OR MISCARRIAGE)"), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), DERMATITIS ALLERGIC ("ALLERGY : RASH/ SKIN CONDITION") AND POST PROCEDURAL COMPLICATION ("POST PROCEDURAL COMPLICATION"). THE PATIENT WAS TREATED WITH SERTRALINE HYDROCHLORIDE (ZOLOFT) AND SURGERY ((B)(6) 2015 HYSTERECTOMY (FULL)). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, VAGINAL HAEMORRHAGE, MENORRHAGIA, MENOMETRORRHAGIA, DEPRESSION, ANXIETY, ANAEMIA AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, GENITAL HAEMORRHAGE AND DERMATITIS ALLERGIC 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 SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, ANAEMIA, ANXIETY, DEPRESSION, DERMATITIS ALLERGIC, GENITAL HAEMORRHAGE, MENOMETRORRHAGIA, MENORRHAGIA, PELVIC PAIN, POST PROCEDURAL COMPLICATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, UTERINE PERFORATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF EXPERIENCED ANOTHER PREGNANCY ON ESSURE WHICH HAS BEEN CAPTURED UNDER CASE : (B)(4). DISCREPANCY- IN CURRENT PFS MENTIONED THAT-HAVE YOU HAD YOUR ESSURE (OR ANY PART OF THE DEVICE) REMOVED? NO. REASON(S) FOR REMOVAL: ESSURE-CAUSED INJURIES. AS ALLEGED IN COMPLAINT. I DO NOT HAVE MONEY AND DEFINITE PLANS FOR REMOVAL AT THIS TIME AND REMOVAL DATE IS GIVEN (B)(6) 2015 IN REMOVAL DETAILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.9 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2009: RESULT- CONFIRMED THAT THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. TOTAL BILATERAL OCCLUSION. FALLOPIAN TUBES WERE BLOCKED; ON (B)(6) 2011: SUCCESSFUL TUBAL STERILIZATION.; ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. PATHOLOGY TEST - ON (B)(6) 2020: (CONTENTS OF MISSED AB, D&C): CHORIONIC VILLI, DIAGNOSTIC OF PRODUCTS OF CONCEPTION. GESTATIONAL TROPHOBLASTIC DISEASE IS NOT SEEN.. ULTRASOUND SCAN VAGINA - ON (B)(6) 2010: IMPRESSION: FAILED PREGNANCY/MISSED ABORTION WITH A 7-WEEK-5-DAY FETAL POLE. 3.8 CM LEFT OVARIAN CYST LIKELY RESENTING A CORPUS LUTEUM CYST. FOLLOW-UP IS SUGGESTED DOCUMENT TO RESOLUTION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS MEDICAL RECORD: UTERINE PERFORATION & ONE WAS CONFIRMED IN PATIENTS MEDICAL RECORD: ANEMIA, MENOMETRORRHAGIA, DEPRESSION AND PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAY-2020: PLAINTIFF FACT SHEET REPORT RECEIVED. ADDED EVENT POST PROCEDURAL COMPLICATION, GENERAL ABNORMAL BLEEDING, ALLERGY : RASH/ SKIN CONDITION. OUTCOME OF EVENTS GENERAL ABNORMAL BLEEDING, PELVIC PAIN, DERMATITIS ALLERGIC WAS UPDATED AS RECOVERED. 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 ('THE SUCTION CURETTAGE WAS PERFORMED WITHOUT INCIDENT AFTER WHICH THE DIAGNOSTIC LAP WAS PERFORMED TO EVALUATE THE LOCATION OF THE PERFORATION. IT WAS ACTUALLY FOUND TO BE IN THE MID POSTERIOR ASPECT OF THE UTERUS AND WAS HAVING MINIMAL BLEEDING.'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY (STILBIRTH OR MISCARRIAGE)') AND ABORTION SPONTANEOUS ('PREGNANCY (STILBIRTH OR MISCARRIAGE)') IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822369) 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 OBESITY, MULTIGRAVIDA, PARITY 4 ((B)(6) 1998, (B)(6) 2000,(B)(6) 2003, (B)(6) 2006), OVARIAN CYSTECTOMY, UTERINE BLEEDING, RECURRENT ABORTION, ABORTION, PREGNANCY WITH CONTRACEPTIVE DEVICE ((B)(6) 2009 PREGNANCY (STILLBIRTH OR MISCARRIAGE)) AND ABORTION SPONTANEOUS ((B)(6) 2009 PREGNANCY (STILLBIRTH OR MISCARRIAGE)). CONCURRENT CONDITIONS INCLUDED GENITAL BLEEDING, CERVICITIS, NABOTHIAN CYST, ENDOCERVICAL SQUAMOUS METAPLASIA AND ADENOMYOSIS. CONCOMITANT PRODUCTS INCLUDED KETOROLAC TROMETHAMINE (TORADOL) AND PARACETAMOL (TYLENOL) SINCE (B)(6) 2009. IN (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2009, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENOMETRORRHAGIA ("MENOMETRORRHAGIA"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH"), PELVIC PAIN ("PHYSICAL PAIN\ PAIN PELVIC AREA"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH") AND ANAEMIA ("BLOOD OR HEART DISORDER/CONDITION TYPE:ANEMIA"). ON (B)(6) 2010, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SERTRALINE HYDROCHLORIDE (ZOLOFT) AND SURGERY ((B)(6) 2015 HYSTERECTOMY (FULL)). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, VAGINAL HAEMORRHAGE, MENORRHAGIA, MENOMETRORRHAGIA, DEPRESSION, PELVIC PAIN, ANXIETY AND ANAEMIA 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 ABORTION SPONTANEOUS, ANAEMIA, ANXIETY, DEPRESSION, MENOMETRORRHAGIA, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, UTERINE PERFORATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF EXPERIENCED ANOTHER PREGNANCY ON ESSURE WHICH HAS BEEN CAPTURED UNDER CASE : (B)(4). DISCREPANCY- IN CURRENT PFS MENTIONED THAT-HAVE YOU HAD YOUR ESSURE (OR ANY PART OF THE DEVICE) REMOVED? NO. REASON(S) FOR REMOVAL: ESSURE-CAUSED INJURIES. AS ALLEGED IN COMPLAINT. I DO NOT HAVE MONEY AND DEFINITE PLANS FOR REMOVAL AT THIS TIME AND REMOVAL DATE IS GIVEN (B)(6) 2015 IN REMOVAL DETAILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.9 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2009: RESULT- CONFIRMED THAT THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. TOTAL BILATERAL OCCLUSION. FALLOPIAN TUBES WERE BLOCKED. ULTRASOUND SCAN VAGINA - ON (B)(6) 2010: IMPRESSION: 1. FAILED PREGNANCY/MISSED ABORTION WITH A 7-WEEK-5-DAY FETAL POLE. 2. 3.8 CM LEFT OVARIAN CYST LIKELY RESENTING A CORPUS LUTEUM CYST. FOLLOW-UP IS SUGGESTED DOCUMENT TO RESOLUTION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS MEDICAL RECORD: UTERINE PERFORATION & ONE WAS CONFIRMED IN PATIENTS MEDICAL RECORD: ANEMIA. 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 PTC(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 ('THE SUCTION CURETTAGE WAS PERFORMED WITHOUT INCIDENT AFTER WHICH THE DIAGNOSTIC LAP WAS PERFORMED TO EVALUATE THE LOCATION OF THE PERFORATION. IT WAS ACTUALLY FOUND TO BE IN THE MID POSTERIOR ASPECT OF THE UTERUS AND WAS HAVING MINIMAL BLEEDING.'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY (STILLBIRTH OR MISCARRIAGE)') AND ABORTION SPONTANEOUS ('PREGNANCY (STILLBIRTH OR MISCARRIAGE)') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822369) 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 OBESITY, MULTIGRAVIDA, PARITY 4 ((B)(6) 1998, (B)(6) 2000,(B)(6) 2003, (B)(6) 2006), OVARIAN CYSTECTOMY, UTERINE BLEEDING, RECURRENT ABORTION, ABORTION, PREGNANCY WITH CONTRACEPTIVE DEVICE ((B)(6) 2009 PREGNANCY (STILLBIRTH OR MISCARRIAGE)) AND ABORTION SPONTANEOUS ((B)(6) 2009 PREGNANCY (STILLBIRTH OR MISCARRIAGE)). CONCURRENT CONDITIONS INCLUDED GENITAL BLEEDING, CERVICITIS, NABOTHIAN CYST, ENDOCERVICAL SQUAMOUS METAPLASIA AND ADENOMYOSIS. CONCOMITANT PRODUCTS INCLUDED KETOROLAC TROMETHAMINE (TORADOL) AND PARACETAMOL (TYLENOL) SINCE (B)(6) 2009. IN (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2009, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENOMETRORRHAGIA ("MENOMETRORRHAGIA"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH"), PELVIC PAIN ("PHYSICAL PAIN\ PAIN PELVIC AREA"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH") AND ANAEMIA ("BLOOD OR HEART DISORDER/CONDITION TYPE:ANEMIA"). ON (B)(6) 2010, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SERTRALINE HYDROCHLORIDE (ZOLOFT) AND SURGERY ((B)(6) 2015 HYSTERECTOMY (FULL)). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, VAGINAL HAEMORRHAGE, MENORRHAGIA, MENOMETRORRHAGIA, DEPRESSION, PELVIC PAIN, ANXIETY AND ANAEMIA 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 ABORTION SPONTANEOUS, ANAEMIA, ANXIETY, DEPRESSION, MENOMETRORRHAGIA, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, UTERINE PERFORATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF EXPERIENCED ANOTHER PREGNANCY ON ESSURE WHICH HAS BEEN CAPTURED UNDER CASE: 2019-121986. DISCREPANCY- IN CURRENT PFS MENTIONED THAT-HAVE YOU HAD YOUR ESSURE (OR ANY PART OF THE DEVICE) REMOVED? NO. REASON(S) FOR REMOVAL: ESSURE-CAUSED INJURIES. AS ALLEGED IN COMPLAINT. I DO NOT HAVE MONEY AND DEFINITE PLANS FOR REMOVAL AT THIS TIME AND REMOVAL DATE IS GIVEN (B)(6) 2015 IN REMOVAL DETAILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.9 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2009: RESULT- CONFIRMED THAT THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. TOTAL BILATERAL OCCLUSION. FALLOPIAN TUBES WERE BLOCKED.. ULTRASOUND SCAN VAGINA - ON (B)(6) 2010: IMPRESSION: FAILED PREGNANCY/MISSED ABORTION WITH A 7-WEEK-5-DAY FETAL POLE. 3.8 CM LEFT OVARIAN CYST LIKELY RESENTING A CORPUS LUTEUM CYST. FOLLOW-UP IS SUGGESTED DOCUMENT TO RESOLUTION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS MEDICAL RECORD: UTERINE PERFORATION & ONE WAS CONFIRMED IN PATIENTS MEDICAL RECORD: ANEMIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-JUN-2019: PFS AND MR RECEIVED: LOT NO. WAS ADDED. REPORTER WAS ADDED. NEW EVENTS-VAGINAL BLEEDING, MENORRHAGIA, PREGNANCY (STILLBIRTH OR MISCARRIAGE), DEPRESSION,MENTAL ANGUISH, ANEMIA, DEVICE INEFFECTIVE, MENOMETRORRHAGIA WERE ADDED & ONE EVENT UTERINE PERFORATION CAPTURED FROM MR. TREATMENT DRUG WAS ADDED. CONCOMITANT DRUGS & CONDITIONS WERE ADDED. LAB TEST WAS ADDED & UPDATED. 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 |
|---|---|---|---|---|---|---|---|
| 534006 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822369 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other| R | ACETAMINOPHEN.| NSAIDS.| TORADOL.| TORADOL.| TORADOL.| TYLENOL [PARACETAMOL]| TYLENOL [PARACETAMOL].| TYLENOL.| TORADOL| TYLENOL (PARACETAMOL) |