ESSURE
Report
- Report Number
- 2951250-2019-00099
- Event Type
- Injury
- Date Received
- January 3, 2019
- Date of Event
- January 1, 2011
- Report Date
- July 20, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE'), GENITAL HAEMORRHAGE ('HEAVY BLEEDING') AND ABORTION SPONTANEOUS ('PREGNANCY (MISCARRIAGE)') IN A 22-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) 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" IN 2012. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 3 (DATES OF LIVE BIRTHS: (B)(6) 2007, (B)(6) 2008, (B)(6) 2009, (B)(6) 2011 (SIC)), CHOLECYSTECTOMY AND SMOKER. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CODEINE PHOSPHATE, ACETAMINOPHEN, LORATADINE, PROPOXYPHENE NAPSYLATE AND CLARITIN. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED HYPERSENSITIVITY WITH ACETAMINOPHEN, CLARITIN, CODEINE PHOSPHATE, LORATADINE AND PROPOXYPHENE NAPSYLATE. CONCURRENT CONDITIONS INCLUDED TOOTH PAIN, BIPOLAR DISORDER, DEPRESSION, SUICIDAL IDEATION AND ANEMIA. CONCOMITANT PRODUCTS INCLUDED TOPIRAMATE SINCE 2016 FOR HEADACHE AND MIGRAINE AS WELL AS IRON AND LAMOTRIGINE SINCE 2016. IN 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HYPERSENSITIVITY ("ALLERGIC REACTION") AND ABDOMINAL PAIN ("CRAMPING"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (MENORRHAGIA)"). IN 2012, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), BACK PAIN ("SEVERE BACK PAIN"), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE)") AND PELVIC PAIN ("PAIN"). IN 2014, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANT WITH ESSURE MICRO-INSERT"). IN 2015, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("MIGRAINE HEADACHES") AND HEADACHE ("HEADACHES"). THE PATIENT WAS TREATED WITH HYDROCODONE BITARTRATE;PARACETAMOL (NORCO), HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), IBUPROFEN AND SURGERY (REMOVAL SURGERY FOR ESSURE). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, HYPERSENSITIVITY, ABDOMINAL PAIN, MIGRAINE, FEMALE SEXUAL DYSFUNCTION, BACK PAIN, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, ALLERGY TO METALS, DYSPAREUNIA, PELVIC PAIN AND HEADACHE OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 5, PARA 3. 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, ALLERGY TO METALS, BACK PAIN, DEVICE DISLOCATION, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, HYPERSENSITIVITY, MIGRAINE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: (B)(6) 2011-INSERTION DETAILS. PROCEDURE DETAILS: AT THIS TIME WE WERE ABLE TO SEE BOTH OSTIA VERY CLEARLY. WE WERE FIRST ABLE TO PLACE THE INTRODUCER DEVICE AND EASILY PLACE THE ESSURE DEVICE IN THE USUAL FASHION ON THE PATIENT'S LEFT SIDE. ON THE PATIENT'S LEFT SIDE, THE DEVICE DID HAVE A LITTLE BIT OF A STIFFNESS TO IT AND ALTHOUGH I HAD TRAILING COILS ON THE PATIENT'S LEFT, I COULD JUST SEE THE END OF THE COILS AT THE PATIENT'S OSTIUM ON HER RIGHT. SHE HAD NOT UNDERGONE ESURE REMOVAL, HOWEVER IS CURRENTLY PLANNING FOR ESSURE REMOVAL DUE TO ALL INJURIES SUSTAINED SINCE IMPLANT. DOCTOR STATED THAT SHE WOULD HAVE TO GET A HYSTERECTOMY TO REMOVE COILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD TEST - IN 2014: PREGNANT. HYSTEROSALPINGOGRAM - IN (B)(6) 2011: RESULTS: CONFIRMED PROPER PLACEMENT OF COILS; ON (B)(6) 2011: EVIDENCE TO SUGGEST OCCLUSION OF BOTH FALLOPIAN TUBES AFTER RECENT ESSURE PROCEDURE. PREGNANCY TEST URINE - ON (B)(6) 2014: NEGATIVE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS MEDICAL RECORD: BACK PAIN AND VAGINAL HAEMORRHAGE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-JUL-2021: NO NEW INFORMATION WAS RECEIVED, THEN MENTION THE UPDATE OF BOTH IMDRF/FDA CODES AS THE ONLY CHANGE. MR RECEIVED: REPORTER WAS ADDED, DEVICE REMOVED, ESSURE REMOVAL DATE 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 DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), ABORTION SPONTANEOUS ("PREGNANCY (MISCARRIAGE)") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANT WITH ESSURE MICRO-INSERT") IN A 22-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) 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" IN 2012. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 3 (DATES OF LIVE BIRTHS: (B)(6) 2007, (B)(6) 2008, (B)(6) 2009, (B)(6) 2011 (SIC)), CHOLECYSTECTOMY AND SMOKER. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CODEINE PHOSPHATE, ACETAMINOPHEN, LORATADINE, PROPOXYPHENE NAPSYLATE AND CLARITIN. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED HYPERSENSITIVITY WITH ACETAMINOPHEN, CLARITIN, CODEINE PHOSPHATE, LORATADINE AND PROPOXYPHENE NAPSYLATE. CONCURRENT CONDITIONS INCLUDED TOOTH PAIN, BIPOLAR DISORDER, DEPRESSION, SUICIDAL IDEATION AND ANEMIA. CONCOMITANT PRODUCTS INCLUDED TOPIRAMATE SINCE 2016 FOR HEADACHE AND MIGRAINE AS WELL AS IRON AND LAMOTRIGINE SINCE 2016. IN 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HYPERSENSITIVITY ("ALLERGIC REACTION") AND ABDOMINAL PAIN ("CRAMPING"). ON(B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). IN 2012, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), BACK PAIN ("SEVERE BACK PAIN"), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE)") AND PELVIC PAIN ("PAIN"). IN 2014, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2015, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIGRAINE ("MIGRAINE HEADACHES") AND HEADACHE ("HEADACHES"). THE PATIENT WAS TREATED WITH HYDROCODONE BITARTRATE;PARACETAMOL (NORCO), HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN) AND IBUPROFEN. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, HYPERSENSITIVITY, ABDOMINAL PAIN, MIGRAINE, FEMALE SEXUAL DYSFUNCTION, BACK PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, ALLERGY TO METALS, DYSPAREUNIA, PELVIC PAIN AND HEADACHE OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 5, PARA 3. 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, ALLERGY TO METALS, BACK PAIN, DEVICE DISLOCATION, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: (B)(6) 2011 -INSERTION DETAILS. PROCEDURE DETAILS: AT THIS TIME WE WERE ABLE TO SEE BOTH OSTIA VERY CLEARLY. WE WERE FIRST ABLE TO PLACE THE INTRODUCER DEVICE AND EASILY PLACE THE ESSURE DEVICE IN THE USUAL FASHION ON THE PATIENT'S LEFT SIDE. ON THE PATIENT'S LEFT SIDE, THE DEVICE DID HAVE A LITTLE BIT OF A STIFFNESS TO IT AND ALTHOUGH I HAD TRAILING COILS ON THE PATIENT'S LEFT, I COULD JUST SEE THE END OF THE COILS AT THE PATIENT'S OSTIUM ON HER RIGHT. SHE HAD NOT UNDERGONE ESURE REMOVAL, HOWEVER IS CURRENTLY PLANNING FOR ESSURE REMOVAL DUE TO ALL INJURIES SUSTAINED SINCE IMPLANT. DOCTOR STATED THAT SHE WOULD HAVE TO GET A HYSTERECTOMY TO REMOVE COILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD TEST - IN 2014: PREGNANT. HYSTEROSALPINGOGRAM - IN 2011: RESULTS: CONFIRMED PROPER PLACEMENT OF COILS; ON (B)(6) 2011: EVIDENCE TO SUGGEST OCCLUSION OF BOTH FALLOPIAN TUBES AFTER RECENT ESSURE PROCEDURE. PREGNANCY TEST URINE - ON (B)(6) 2014: NEGATIVE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS MEDICAL RECORD: BACK PAIN AND VAGINAL HAEMORRHAGE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-MAR-2019: PLAINTIFF FACT SHEET RECEIVED : NEW EVENT OF "HEADACHES" 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 OF ESSURE DEVICE"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), ABORTION SPONTANEOUS ("PREGNANCY (MISCARRIAGE)") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANT WITH ESSURE MICRO-INSERT") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) 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" IN 2012. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 3 (DATES OF LIVE BIRTHS: (B)(6) 2007, (B)(6) 2008, (B)(6) 2009, (B)(6) 2011 (SIC)), CHOLECYSTECTOMY AND SMOKER. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CODEINE PHOSPHATE, ACETAMINOPHEN, LORATADINE, PROPOXYPHENE NAPSYLATE AND CLARITIN. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED HYPERSENSITIVITY WITH ACETAMINOPHEN, CLARITIN, CODEINE PHOSPHATE, LORATADINE AND PROPOXYPHENE NAPSYLATE. CONCURRENT CONDITIONS INCLUDED TOOTH PAIN, BIPOLAR DISORDER, DEPRESSION, SUICIDAL IDEATION AND ANEMIA. CONCOMITANT PRODUCTS INCLUDED IRON, LAMOTRIGINE SINCE 2016 AND TOPIRAMATE SINCE 2016. IN 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HYPERSENSITIVITY ("ALLERGIC REACTION") AND ABDOMINAL PAIN ("CRAMPING"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). IN 2012, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), BACK PAIN ("SEVERE BACK PAIN"), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE)") AND PELVIC PAIN ("PAIN"). IN 2014, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2015, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE HEADACHES"). THE PATIENT WAS TREATED WITH HYDROCODONE BITARTRATE;PARACETAMOL (NORCO), HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN) AND IBUPROFEN. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, HYPERSENSITIVITY, ABDOMINAL PAIN, MIGRAINE, FEMALE SEXUAL DYSFUNCTION, BACK PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, ALLERGY TO METALS, DYSPAREUNIA AND PELVIC PAIN OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 5, PARA 3. 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, ALLERGY TO METALS, BACK PAIN, DEVICE DISLOCATION, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: (B)(6) 2011. INSERTION DETAILS. PROCEDURE DETAILS: AT THIS TIME WE WERE ABLE TO SEE BOTH OSTIA VERY CLEARLY. WE WERE FIRST ABLE TO PLACE THE INTRODUCER DEVICE AND EASILY PLACE THE ESSURE DEVICE IN THE USUAL FASHION ON THE PATIENT'S LEFT SIDE. ON THE PATIENT'S LEFT SIDE [AS WRITTEN] WE WERE ALSO ABLE TO DO THIS; HOWEVER, THE DEVICE DID HAVE A LITTLE BIT OF A STIFFNESS TO IT AND ALTHOUGH I HAD TRAILING COILS ON THE PATIENT'S LEFT, I COULD JUST SEE THE END OF THE COILS AT THE PATIENT'S OSTIUM ON HER RIGHT. SHE HAD NOT UNDERGONE ESSURE REMOVAL OR CURRENTLY PLANNING FOR ESSURE REMOVAL. DOCTOR STATED THAT SHE WOULD HAVE TO GET A HYSTERECTOMY TO REMOVE COILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD TEST - IN 2014: PREGNANT. HYSTEROSALPINGOGRAM - IN 2011: RESULTS: CONFIRMED PROPER PLACEMENT OF COILS; ON (B)(6) 2011: EVIDENCE TO SUGGEST OCCLUSION OF BOTH FALLOPIAN TUBES AFTER RECENT ESSURE PROCEDURE. PREGNANCY TEST URINE - ON (B)(6) 2014: NEGATIVE. "CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS MEDICAL RECORD: BACK PAIN AND VAGINAL HAEMORRHAGE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED. EVENT "MIGRATION OF ESSURE DEVICE" ADDED FROM PFS. 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 |
|---|---|---|---|---|---|---|---|
| 8111 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822365 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Other| R | IRON| IRON| IRON| LAMOTRIGINE| LAMOTRIGINE| LAMOTRIGINE| TOPIRAMATE| TOPIRAMATE| TOPIRAMATE| IRON| LAMOTRIGINE| TOPIRAMATE |