ESSURE
Report
- Report Number
- 2951250-2023-02282
- Event Type
- Injury
- Date Received
- May 23, 2023
- Date of Event
- March 1, 2016
- Report Date
- March 27, 2024
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY WITH CONTRACEPTIVE DEVICE") IN A 31 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. B30426) FOR PERMANENT CONTRACEPTIVE TUBAL IMPLANT. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE ("DEVICE INEFFECTIVE"). THE PATIENT HAD A MEDICAL HISTORY OF ABDOMINAL PAIN, DYSMENORRHEA, HEADACHE, OVARIAN CYST, VAGINAL BLEEDING AND C-SECTION. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ESSURE WAS REMOVED ON (B)(6) 2016. ON UNKNOWN DATE SHE EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY WITH REMOVAL OF ESSURE). AT THE TIME OF THE REPORT, THE OUTCOME OF PREGNANCY WITH CONTRACEPTIVE DEVICE WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A HEALTHY CHILD. THE DELIVERY OCCURRED ON AN UNKNOWN DATE. THE REPORTER CONSIDERED PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: LEFT 1 COIL. RIGHT 2 COILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [HYSTEROSALPINGOGRAM] ON (B)(6) 2014: HYSTEROSALPINGOGRAM. HISTORY: STATUS POST ESSURE PROCEDURE. FLUOROSCOPY TIME: 0.1 MINUTES. FINDINGS: CONTRAST WAS INJECTED INTO THE UTERINE CAVITY THE ESSURE MICROINSERTS ARE IN THE EXPECTED POSITION OF THE FALLOPIAN TUBES. CONTRAST IN UTERINE CAVITY APPEARS NORMAL WITHOUT EVIDENCE OF A FILLING DEFECT. NONE OF THE CONTRAST IS VISIBLE IN THE FALLOPIAN TUBES AND NONE OF THE CONTRAST IS VISIBLE IN THE PERITONEAL CAVITY. IMPRESSION: THE APPEARANCE IS CONSISTENT WITH OBSTRUCTED FALLOPIAN TUBES. [ULTRASOUND SCAN] ON (B)(6) 2014: WAS FOUND TO HAVE IUP WITH FHM AT THAT TIME; IN (B)(6) 2016: SHOWED NO EMBRYO, [ULTRASOUND SCAN VAGINA] ON (B)(6) 2014: TRANSABDOMINAL AND TRANSVAGINAL ULTRASOUND PERFORMED. UTERUS: APPEARS NORMAL WITH NO MASSES IDENTIFIED. MEASUREMENT: 8.9 X 5.9 X 6.3CM. RIGHT OVARY: MEASUREMENT: 3.3 X 1.5 X 3.3 CM. LEFT OVARY: MEASUREMENT: 2.9 X 1.6 X 2.3 CM. CONTAINS A SMALL CYST. ADNEXA: NO MASSES IDENTIFIED. CUL DE SAC: NO FREE FLUID SEEN. LARGE COMPLEX AREA LOCATED IN THE CERVIX. ESSURE IMPLANT SEEN BILATERALLY. IMPRESSION: THERE IS NO GESTATIONAL SAC OR FETUS PRESENT WITHIN THE UTERUS. THERE IS A THICKENED ENDOMETRIAL LINING OF 10.9 MM. THERE IS A LARGE AMOUNT OF TISSUE FILLING THE CERVIX WITH A MASS OF TISSUE THAT MEASURES APPROXIMATELY 7 X 3 CM THERE IS A SMALL RESIDUAL CORPUS LUTEUM CYST IN THE LEFT OVARY. THERE IS NO FREE FLUID IN THE CUL-DE-SAC. ESSURE IMPLANTS ARE IDENTIFIED BILATERALLY. LOT NUMBER: B30426. MANUFACTURE DATE: 2013-05. EXPIRATION DATE: 2016-05. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 26-JAN-2024: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS 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 ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY WITH CONTRACEPTIVE DEVICE") IN A 31 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO: B30426) FOR FEMALE STERILISATION. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE ("DEVICE INEFFECTIVE"). THE PATIENT HAD A MEDICAL HISTORY OF ABDOMINAL PAIN, DYSMENORRHEA, HEADACHE, OVARIAN CYST, VAGINAL BLEEDING AND C-SECTION. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ESSURE WAS REMOVED ON (B)(6) 2016. AN UNKNOWN TIME LATER SHE EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY WITH REMOVAL OF ESSURE). AT THE TIME OF THE REPORT, THE OUTCOME OF PREGNANCY WITH CONTRACEPTIVE DEVICE WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A HEALTHY CHILD. THE DELIVERY OCCURRED ON AN UNKNOWN DATE. THE REPORTER CONSIDERED PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: LEFT 1 COIL, RIGHT 2 COILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [HYSTEROSALPINGOGRAM] ON (B)(6) 2014: HYSTERO SALPINGOGRAM. HISTORY: STATUS POST ESSURE PROCEDURE. FLUOROSCOPY TIME: 0.1 MINUTES. FINDINGS: CONTRAST WAS INJECTED INTO THE UTERINE CAVITY THE ESSURE MICROINSERTS ARE IN THE EXPECTED POSITION OF THE FALLOPIAN TUBES. CONTRAST IN UTERINE CAVITY APPEARS NORMAL WITHOUT EVIDENCE OF A FILLING DEFECT. NONE OF THE CONTRAST IS VISIBLE IN THE FALLOPIAN TUBES AND NONE OF THE CONTRAST IS VISIBLE IN THE PERITONEAL CAVITY. IMPRESSION: THE APPEARANCE IS CONSISTENT WITH OBSTRUCTED FALLOPIAN TUBES. [ULTRASOUND SCAN] ON (B)(6) 2014: WAS FOUND TO HAVE IUP WITH FHM AT THAT TIME; ON (B)(6) 2016: SHOWED NO EMBRYO, [ULTRASOUND SCAN VAGINA] ON (B)(6) 2014: TRANSABDOMINAL AND TRANSVAGINAL ULTRASOUND PERFORMED. UTERUS: APPEARS NORMAL WITH NO MASSES IDENTIFIED. MEASUREMENT: 8.9 X 5.9 X 6.3CM. RIGHT OVARY: MEASUREMENT: 3.3 X 1.5 X 3.3 CM. LEFT OVARY: MEASUREMENT: 2.9 X 1.6 X 2.3 CM. CONTAINS A SMALL CYST. ADNEXA: NO MASSES IDENTIFIED. CUL DE SAC: NO FREE FLUID SEEN. LARGE COMPLEX AREA LOCATED IN THE CERVIX. ESSURE IMPLANT SEEN BILATERALLY. IMPRESSION: THERE IS NO GESTATIONAL SAC OR FETUS PRESENT WITHIN THE UTERUS. THERE IS A THICKENED ENDOMETRIAL LINING OF 10.9 MM. THERE IS A LARGE AMOUNT OF TISSUE FILLING THE CERVIX WITH A MASS OF TISSUE. THAT MEASURES APPROXIMATELY 7 X 3 CM. THERE IS A SMALL RESIDUAL CORPUS LUTEUM CYST IN THE LEFT OVARY. THERE IS NO FREE FLUID IN THE CUL-DE-SAC. ESSURE IMPLANTS ARE IDENTIFIED BILATERALLY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PREGNANCY WITH CONTRACEPTIVE DEVICE AND DRUG INEFFECTIVE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 02-NOV-2023: MEDICAL DEVICE REMOVAL WAS UPDATED TO PREGNANCY WITH CONTRACEPTIVE DEVICE AND DEVICE INEFFECTIVE. REPORTERS, PATIENT INFORMATION, MEDICAL HISTORY, LAB DATA, LOT NO, INDICATION, EXPIRY DATE, DRUG REMOVAL DATE, NON DRUG TREATMENT 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 ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("EVIDENCE OF THE PERFORATION OF THE ESSURE DEVICE THROUGH THE LUMEN OF THE FALLOPIAN TUBE, HOWEVER NOT COMPLETELY OUT THROUGH THE SEROSA, EXPOSING THE ESSURE DEVICE BILATERALLY") IN A 31 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. B30426) FOR PERMANENT CONTRACEPTIVE TUBAL IMPLANT. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE ("DEVICE INEFFECTIVE"). THE PATIENT HAD A MEDICAL HISTORY OF ABDOMINAL PAIN, DYSMENORRHEA, HEADACHE, OVARIAN CYST, VAGINAL BLEEDING AND C-SECTION. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ESSURE WAS REMOVED ON (B)(6) 2016. ON UNKNOWN DATE SHE EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED) AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY WITH CONTRACEPTIVE DEVICE"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY WITH REMOVAL OF ESSURE). AT THE TIME OF THE REPORT, THE OUTCOME OF PREGNANCY WITH CONTRACEPTIVE DEVICE WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A HEALTHY CHILD. THE DELIVERY OCCURRED ON AN UNKNOWN DATE. THE REPORTER CONSIDERED FALLOPIAN TUBE PERFORATION AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: LEFT 1 COIL RIGHT 2 COILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [HYSTEROSALPINGOGRAM] ON (B)(6) 2014: HYSTEROSALPINGOGRAM. HISTORY: STATUS POST ESSURE PROCEDURE. FLUOROSCOPY TIME: 0.1 MINUTES. FINDINGS: CONTRAST WAS INJECTED INTO THE UTERINE CAVITY THE ESSURE MICROINSERTS ARE IN THE EXPECTED POSITION OF THE FALLOPIAN TUBES. CONTRAST IN UTERINE CAVITY APPEARS NORMAL WITHOUT EVIDENCE OF A FILLING DEFECT. NONE OF THE CONTRAST IS VISIBLE IN THE FALLOPIAN TUBES AND NONE OF THE CONTRAST IS VISIBLE IN THE PERITONEAL CAVITY. IMPRESSION: THE APPEARANCE IS CONSISTENT WITH OBSTRUCTED FALLOPIAN TUBES. [ULTRASOUND SCAN] ON (B)(6) 2014: WAS FOUND TO HAVE IUP WITH FHM AT THAT TIME; IN (B)(6) 2016: SHOWED NO EMBRYO, [ULTRASOUND SCAN VAGINA] ON (B)(6) 2014: TRANSABDOMINAL AND TRANSVAGINAL ULTRASOUND PERFORMED. UTERUS: APPEARS NORMAL WITH NO MASSES IDENTIFIED. MEASUREMENT: 8.9 X 5.9 X 6.3CM RIGHT OVARY: MEASUREMENT: 3.3 X 1.5 X 3.3 CM LEFT OVARY: MEASUREMENT: 2.9 X 1.6 X 2.3 CM CONTAINS A SMALL CYST. ADNEXA: NO MASSES IDENTIFIED. CUL DE SAC: NO FREE FLUID SEEN. LARGE COMPLEX AREA LOCATED IN THE CERVIX. ESSURE IMPLANT SEEN BILATERALLY. IMPRESSION: THERE IS NO GESTATIONAL SAC OR FETUS PRESENT WITHIN THE UTERUS. THERE IS A THICKENED ENDOMETRIAL LINING OF 10.9 MM. THERE IS A LARGE AMOUNT OF TISSUE FILLING THE CERVIX WITH A MASS OF TISSUE THAT MEASURES APPROXIMATELY 7 X 3 CM THERE IS A SMALL RESIDUAL CORPUS LUTEUM CYST IN THE LEFT OVARY. THERE IS NO FREE FLUID IN THE CUL-DE-SAC. ESSURE IMPLANTS ARE IDENTIFIED BILATERALLY. LOT NUMBER: B30426 MANUFACTURE DATE: 2013-05 EXPIRATION DATE: 2016-05. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. THE FOLLOWING AMENDMENT WAS MADE: FALLOPIAN TUBE PERFORATION EVENT ADDED. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS 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 ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 31 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, THE DAY OF ATTEMPTED INSERTION OF ESSURE, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED, AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 15-JUN-2023: 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 ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 31 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2016, THE DAY OF ATTEMPTED INSERTION OF ESSURE, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED, AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1449521 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | B30426 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Female | Required Intervention| O |