ESSURE
Report
- Report Number
- 2951250-2023-01897
- Event Type
- Injury
- Date Received
- May 10, 2023
- Date of Event
- September 30, 2021
- Report Date
- January 28, 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 AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 46 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 771092) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF OBESITY, SEASONAL ALLERGY, MIGRAINE, IRRITABLE BOWEL SYNDROME, TYPE 2 DIABETES MELLITUS, HYPERTENSION, DRUG ALLERGY (PENICILLIN, SULFA, IODINE, PROPOXYPHENE, SHELLFISH AND ACETAMINOPHEN), MENOMETRORRHAGIA, SHOULDER PAIN, BACK PAIN, PARITY 2, C-SECTION, THYROID DISORDER, ANEMIA, ASTHMA, HEADACHE, MIGRAINE, OBESITY, PRE-ECLAMPSIA AND MULTI GRAVIDA. BEHAVIORAL: NO TOBACCO USE. ALCOHOL: NOT USING ALCOHOL. DRUG USE: NOT USING DRUGS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2021, 3535 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY - UTERUS). 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. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [PATHOLOGY TEST] ON (B)(6) 2021: FINAL DIAGNOSIS: CERVIX: NABOTHIAN CYSTS. ENDOMETRIUM: SECRETORY PHASE ENDOMETRIUM. MYOMETRIUM: SMALL, INTRAMURAL LEIOMYOMA AND FOCAL ADENOMYOSIS. SEROSA: ADHEIONS. RIGHT FALLOPIAN TUBE: METALLIC ESSURE COIL PRESENT IN THE CORNU; FOCAL ENDOSALPINGIOSIS LEFT FALLOPIAN TUBE: METALLIC ESSURE COIL PRESENT IN THE CORNU. SECTIONS FROM THE RIGHT FALLOPIAN TUBE ARE BENIGN. THERE ARE FOCI OF ENDOSALPINGIOSIS NOTED. SECTIONS OF THE LEFT FALLOPIAN TUBE ARE ALSO BENIGN. GROSS DESCRIPTION: RECEIVED IN FORMALIN LABELED "CERVIX, UTERUS, BILATERAL FALLOPIAN TUBES" IS AN INTACT UTERINE BODY WITH ATTACHED CERVIX AND BILATERAL FALLOPIAN TUBES. THE LEFT FALLOPIAN TUBE IS FIMBRIATED, AND THE RIGHT FALLOPIAN TUBE SHOWS A CAUTERIZED DISTAL END WITHOUT FIMBRIAE. NO OVARIAN TISSUE IS RECEIVED. WEIGHT AND DIMENSION: WITH THE FALLOPIAN TUBES REMOVED, THE UTERINE BODY AND CERVIX WEIGH 70 GRAMS. THE UTERINE CORPUS IS 4.5 CM FROM SUPERIOR TO INFERIOR, 4.7 CM FROM CORNU TO CORNU, AND 3.6 CM FROM ANTERIOR TO POSTERIOR. RIGHT FALLOPIAN TUBE: THE RIGHT FALLOPIAN TUBE IS 4.9 OM IN LENGTH AND RANGES IN DIAMETER FROM 0.7 TO 1.1 CM. THE SEROSA IS TAN-PURPLE, SMOOTH AND GLISTENING TO FOCALLY RAGGED AND CAUTERIZED NEAR THE DISTAL END. THE LUMEN OF THE PROXIMAL FALLOPIAN TUBE CONTAINS A GRAY METALLIC COIL, WHICH FOCALLY EXTENDS INTO THE MYOMETRIUM AT THE CORNU BUT DOES NOT EXTEND INTO THE INTRAUTERINE CAVITY. SECTIONING REVEALS A PINPOINT TO STELLATE LUMEN. LEFT FALLOPIAN TUBE: THE LEFT FALLOPIAN TUBE IS 4.6 CM IN LENGTH AND RANGES IN DIAMETER FROM 0.6 TO 0.9 CM. THE SEROSA IS TAN-PURPLE, SMOOTH AND GLISTENING TO FOCALLY RAGGED, AND SHOWS A FEW DELICATE, RAGGED FIBROUS ADHESIONS. THE PROXIMAL FALLOPIAN TUBE LUMEN CONTAINS A GRAY METALLIC COIL, WHICH FOCALLY EXTENDS INTO THE MYOMETRIUM AT THE CORNU BUT DOES NOT EXTEND INTO THE INTRAUTERINE CAVITY. SECTIONING REVEALS A PINPOINT TO STELLATE LUMEN. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 03-SEP-2023: MEDICAL RECORD RECEIVED. SURGICAL PATHOLOGY REPORT UPDATED. LOT NUMBER ADDED. MEDICAL HISTORY ADDED. REPORTER INFORMATION UPDATED. 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 AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 46 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6), 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6), 2021, 3506 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED) WITH SURGERY (HYSTERECTOMY - UTERUS). 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: (B)(6), 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 46 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 771092-INVALID) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF OBESITY, SEASONAL ALLERGY, MIGRAINE, IRRITABLE BOWEL SYNDROME, TYPE 2 DIABETES MELLITUS, HYPERTENSION, DRUG ALLERGY (PENICILLIN, SULFA, IODINE, PROPOXYPHENE, SHELLFISH AND ACETAMINOPHEN), MENOMETRORRHAGIA, SHOULDER PAIN, BACK PAIN, PARITY 2, C-SECTION, THYROID DISORDER, ANEMIA, ASTHMA, HEADACHE, MIGRAINE, OBESITY, PRE-ECLAMPSIA AND MULTI GRAVIDA. BEHAVIORAL: NO TOBACCO USE. ALCOHOL: NOT USING ALCOHOL. DRUG USE: NOT USING DRUGS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2021, 3535 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY - UTERUS). 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. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [PATHOLOGY TEST] ON (B)(6) 2021: FINAL DIAGNOSIS: CERVIX: NABOTHIAN CYSTS. ENDOMETRIUM: SECRETORY PHASE ENDOMETRIUM MYOMETRIUM: SMALL, INTRAMURAL LEIOMYOMA AND FOCAL ADENOMYOSIS SEROSA: ADHEIONS RIGHT FALLOPIAN TUBE: METALLIC ESSURE COIL PRESENT IN THE CORNU; FOCAL ENDOSALPINGIOSIS LEFT FALLOPIAN TUBE: METALLIC ESSURE COIL PRESENT IN THE CORNU. SECTIONS FROM THE RIGHT FALLOPIAN TUBE ARE BENIGN. THERE ARE FOCI OF ENDOSALPINGIOSIS NOTED. SECTIONS OF THE LEFT FALLOPIAN TUBE ARE ALSO BENIGN. GROSS DESCRIPTION: RECEIVED IN FORMALIN LABELED "CERVIX, UTERUS, BILATERAL FALLOPIAN TUBES" IS AN INTACT UTERINE BODY WITH ATTACHED CERVIX AND BILATERAL FALLOPIAN TUBES. THE LEFT FALLOPIAN TUBE IS FIMBRIATED, AND THE RIGHT FALLOPIAN TUBE SHOWS A CAUTERIZED DISTAL END WITHOUT FIMBRIAE. NO OVARIAN TISSUE IS RECEIVED. WEIGHT AND DIMENSION: WITH THE FALLOPIAN TUBES REMOVED, THE UTERINE BODY AND CERVIX WEIGH 70 GRAMS. THE UTERINE CORPUS IS 4.5 CM FROM SUPERIOR TO INFERIOR, 4.7 CM FROM CORNU TO CORNU, AND 3.6 CM FROM ANTERIOR TO POSTERIOR. RIGHT FALLOPIAN TUBE: THE RIGHT FALLOPIAN TUBE IS 4.9 OM IN LENGTH AND RANGES IN DIAMETER FROM 0.7 TO 1.1 CM. THE SEROSA IS TAN-PURPLE, SMOOTH AND GLISTENING TO FOCALLY RAGGED AND CAUTERIZED NEAR THE DISTAL END. THE LUMEN OF THE PROXIMAL FALLOPIAN TUBE CONTAINS A GRAY METALLIC COIL, WHICH FOCALLY EXTENDS INTO THE MYOMETRIUM AT THE CORNU BUT DOES NOT EXTEND INTO THE INTRAUTERINE CAVITY. SECTIONING REVEALS A PINPOINT TO STELLATE LUMEN. LEFT FALLOPIAN TUBE: THE LEFT FALLOPIAN TUBE IS 4.6 CM IN LENGTH AND RANGES IN DIAMETER FROM 0.6 TO 0.9 CM. THE SEROSA IS TAN-PURPLE, SMOOTH AND GLISTENING TO FOCALLY RAGGED, AND SHOWS A FEW DELICATE, RAGGED FIBROUS ADHESIONS. THE PROXIMAL FALLOPIAN TUBE LUMEN CONTAINS A GRAY METALLIC COIL, WHICH FOCALLY EXTENDS INTO THE MYOMETRIUM AT THE CORNU BUT DOES NOT EXTEND INTO THE INTRAUTERINE CAVITY. SECTIONING REVEALS A PINPOINT TO STELLATE LUMEN. 771092-INVALID. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 29-SEP-2023: UPDATE OF INFORMATION (BATCH IS INVALID). AN INVALID LOT NUMBER WAS RECEIVED IN THIS CASE. 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 46 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 771092) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF OBESITY, SEASONAL ALLERGY, MIGRAINE, IRRITABLE BOWEL SYNDROME, TYPE 2 DIABETES MELLITUS, HYPERTENSION, DRUG ALLERGY (PENICILLIN, SULFA, IODINE, PROPOXYPHENE, SHELLFISH AND ACETAMINOPHEN), MENOMETRORRHAGIA, SHOULDER PAIN, BACK PAIN, PARITY 2, C-SECTION, THYROID DISORDER, ANEMIA, ASTHMA, HEADACHE, MIGRAINE, OBESITY, PRE-ECLAMPSIA AND MULTI GRAVIDA. BEHAVIORAL: NO TOBACCO USE. ALCOHOL: NOT USING ALCOHOL. DRUG USE: NOT USING DRUGS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2021, 3535 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY - UTERUS). 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. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [PATHOLOGY TEST] ON (B)(6) 2021: FINAL DIAGNOSIS: CERVIX: NABOTHIAN CYSTS. ENDOMETRIUM: SECRETORY PHASE ENDOMETRIUM MYOMETRIUM: SMALL, INTRAMURAL LEIOMYOMA AND FOCAL ADENOMYOSIS SEROSA: ADHEIONS RIGHT FALLOPIAN TUBE: METALLIC ESSURE COIL PRESENT IN THE CORNU; FOCAL ENDOSALPINGIOSIS LEFT FALLOPIAN TUBE: METALLIC ESSURE COIL PRESENT IN THE CORNU. SECTIONS FROM THE RIGHT FALLOPIAN TUBE ARE BENIGN. THERE ARE FOCI OF ENDOSALPINGIOSIS NOTED. SECTIONS OF THE LEFT FALLOPIAN TUBE ARE ALSO BENIGN. GROSS DESCRIPTION: RECEIVED IN FORMALIN LABELED "CERVIX, UTERUS, BILATERAL FALLOPIAN TUBES" IS AN INTACT UTERINE BODY WITH ATTACHED CERVIX AND BILATERAL FALLOPIAN TUBES. THE LEFT FALLOPIAN TUBE IS FIMBRIATED, AND THE RIGHT FALLOPIAN TUBE SHOWS A CAUTERIZED DISTAL END WITHOUT FIMBRIAE. NO OVARIAN TISSUE IS RECEIVED. WEIGHT AND DIMENSION: WITH THE FALLOPIAN TUBES REMOVED, THE UTERINE BODY AND CERVIX WEIGH 70 GRAMS. THE UTERINE CORPUS IS 4.5 CM FROM SUPERIOR TO INFERIOR, 4.7 CM FROM CORNU TO CORNU, AND 3.6 CM FROM ANTERIOR TO POSTERIOR. RIGHT FALLOPIAN TUBE: THE RIGHT FALLOPIAN TUBE IS 4.9 OM IN LENGTH AND RANGES IN DIAMETER FROM 0.7 TO 1.1 CM. THE SEROSA IS TAN-PURPLE, SMOOTH AND GLISTENING TO FOCALLY RAGGED AND CAUTERIZED NEAR THE DISTAL END. THE LUMEN OF THE PROXIMAL FALLOPIAN TUBE CONTAINS A GRAY METALLIC COIL, WHICH FOCALLY EXTENDS INTO THE MYOMETRIUM AT THE CORNU BUT DOES NOT EXTEND INTO THE INTRAUTERINE CAVITY. SECTIONING REVEALS A PINPOINT TO STELLATE LUMEN. LEFT FALLOPIAN TUBE: THE LEFT FALLOPIAN TUBE IS 4.6 CM IN LENGTH AND RANGES IN DIAMETER FROM 0.6 TO 0.9 CM. THE SEROSA IS TAN-PURPLE, SMOOTH AND GLISTENING TO FOCALLY RAGGED, AND SHOWS A FEW DELICATE, RAGGED FIBROUS ADHESIONS. THE PROXIMAL FALLOPIAN TUBE LUMEN CONTAINS A GRAY METALLIC COIL, WHICH FOCALLY EXTENDS INTO THE MYOMETRIUM AT THE CORNU BUT DOES NOT EXTEND INTO THE INTRAUTERINE CAVITY. SECTIONING REVEALS A PINPOINT TO STELLATE LUMEN. 771092-INVALID. 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: UPDATED QUALITY-SAFETY EVALUATION OF PTC. AN INVALID LOT NUMBER WAS RECEIVED IN THIS CASE. 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 46 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2021, 3506 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY - UTERUS). 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 WILL BE 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 |
|---|---|---|---|---|---|---|---|
| 686860 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 771092 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Female | Required Intervention |