ESSURE
Report
- Report Number
- 2951250-2019-04964
- Event Type
- Injury
- Date Received
- August 21, 2019
- Date of Event
- December 6, 2011
- Report Date
- May 28, 2020
- 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 FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBE(S) / RIGHT SIDE'), UTERINE PERFORATION ('PERFORATION: UTERUS') AND DEVICE DISLOCATION ('MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: PERITONEUM/ EPIPLOICA NEAR THE JUNCTION OF THE ILEUM AND CECUM/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: PERITONEUM/ EPIPLOICA NEAR THE JUNCTION OF THE ILEUM AND CECUM') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841532) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED UTERINE DILATION AND CURETTAGE AND MENSTRUATION DELAYED. CONCURRENT CONDITIONS INCLUDED CRAMP IN LOWER ABDOMEN. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;LEVONORGESTREL (LEVORA) SINCE 2006 TO (B)(6) 2012, HYDROCODONE;PARACETAMOL (ACETAMINOPHEN;HYDROCODONE) SINCE (B)(6) 2012, IBUPROFEN FROM (B)(6) 2012 TO (B)(6) 2012 AND NSAIDS SINCE (B)(6) 2011. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DEPRESSION ("DEPRESSION/ PSYCH INJURY") AND ANXIETY ("MENTAL ANGUISH/ PSYCH INJURY/ ANXIETY"). ON (B)(6) 2011, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 MONTHS 14 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING") AND ABDOMINAL PAIN ("PAIN: ABDOMINAL"). THE PATIENT WAS TREATED WITH SURGERY ((HYST. (FULL), ON (B)(6) 2012, LAPAROSCOPIC RIGHT TUBAL LIGATION, HYSTERECTOMY (FULL) AND ON (B)(6) 2012,LAPAROSCOPIC RIGHT TUBAL LIGATION & REMOVAL OF PERFORATED ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, DEVICE DISLOCATION, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA AND ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, UTERINE PERFORATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: VISIBLE COILS SHOWING WITHIN THE ENDOMETRIAL CAVITY AS FOLLOWS: RIGHT: 3 COILS LEFT: 6 COILS ONLY RIGHT ESSURE REMOVED. THE RIGHT ESSURE DEVICE APPEARED TO BE IN THE PERITONEUM AND THE RIGHT FALLOPIAN TUBE WAS NOT OCCLUDED. THE PATIENT HAD A SECOND ATTEMPT AT PLACEMENT OF THE RIGHT SIDED ESSURE, BUT SHE COULD NOT TOLERATE THE PROCEDURE. RECEIVED TREATMENT FOR PERFORATION-YES: PERFORATION: UTERUS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED).. IMAGING PROCEDURE - ON (B)(6) 2011: PERFORATION (FALLOPIAN TUBE). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION AND VAGINAL HEMORRHAGE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: PFS RECEIVED. EVENT OUTCOME WERE UPDATED TO RECOVERED: PAIN , ABNORMAL BLEEDING. 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 REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBE(S) / RIGHT SIDE') AND DEVICE DISLOCATION ('MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: PERITONEUM/ EPIPLOICA NEAR THE JUNCTION OF THE ILEUM AND CECUM/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: PERITONEUM/ EPIPLOICA NEAR THE JUNCTION OF THE ILEUM AND CECUM') IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841532) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED UTERINE DILATION AND CURETTAGE AND MENSTRUATION DELAYED. CONCURRENT CONDITIONS INCLUDED CRAMP IN LOWER ABDOMEN. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;LEVONORGESTREL (LEVORA) SINCE 2006 TO (B)(6)2012, HYDROCODONE;PARACETAMOL (ACETAMINOPHEN;HYDROCODONE) SINCE (B)(6)2012, IBUPROFEN FROM (B)(6)2012 TO (B)(6)2012 AND NSAIDS SINCE (B)(6)2011. ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:MENTAL ANGUISH"). ON (B)(6)2011, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 MONTHS 14 DAYS AFTER INSERTION OF ESSURE. ON (B)(6)2012, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6)2012,LAPAROSCOPIC RIGHT TUBAL LIGATION & REMOVAL OF PERFORATED ESSURE DEVICE). AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN AND THE PELVIC PAIN WAS RESOLVING. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: VISIBLE COILS SHOWING WITHIN THE ENDOMETRIAL CAVITY AS FOLLOWS: RIGHT: 3 COILS LEFT: 6 COILS ONLY RIGHT ESSURE REMOVED. THE RIGHT ESSURE DEVICE APPEARED TO BE IN THE PERITONEUM AND THE RIGHT FALLOPIAN TUBE WAS NOT OCCLUDED. THE PATIENT HAD A SECOND ATTEMPT AT PLACEMENT OF THE RIGHT SIDED ESSURE, BUT SHE COULD NOT TOLERATE THE PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2011: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED),PERFORATION (FALLOPIAN TUBE). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION AND VAGINAL HEMORRHAGE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-AUG-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 FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBE(S) / RIGHT SIDE'), UTERINE PERFORATION ('PERFORATION: UTERUS'), DEVICE DISLOCATION ('MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: PERITONEUM/ EPIPLOICA NEAR THE JUNCTION OF THE ILEUM AND CECUM/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: PERITONEUM/ EPIPLOICA NEAR THE JUNCTION OF THE ILEUM AND CECUM') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841532) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED UTERINE DILATION AND CURETTAGE AND MENSTRUATION DELAYED. CONCURRENT CONDITIONS INCLUDED CRAMP IN LOWER ABDOMEN. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;LEVONORGESTREL (LEVORA) SINCE 2006 TO (B)(6) 2012, HYDROCODONE;PARACETAMOL (ACETAMINOPHEN;HYDROCODONE) SINCE (B)(6) 2012, IBUPROFEN FROM (B)(6) 2012 AND NSAIDS SINCE (B)(6) 2011. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITON:DEPRESSION/ PSYCH INJURY") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITON:MENTAL ANGUISH/ PSYCH INJURY"). ON (B)(6) 2011, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 MONTHS 14 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABDOMINAL PAIN ("PAIN: ABDOMINAL"). THE PATIENT WAS TREATED WITH SURGERY ((HYST. (FULL), ON (B)(6) 2012, LAPAROSCOPIC RIGHT TUBAL LIGATION, HYSTERECTOMY (FULL) AND ON (B)(6) 2012,LAPAROSCOPIC RIGHT TUBAL LIGATION & REMOVAL OF PERFORATED ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, DEVICE DISLOCATION, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, PELVIC PAIN AND ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, UTERINE PERFORATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: VISIBLE COILS SHOWING WITHIN THE ENDOMETRIAL CAVITY AS FOLLOWS: RIGHT: 3 COILS LEFT: 6 COILS. ONLY RIGHT ESSURE REMOVED. THE RIGHT ESSURE DEVICE APPEARED TO BE IN THE PERITONEUM AND THE RIGHT FALLOPIAN TUBE WAS NOT OCCLUDED. THE PATIENT HAD A SECOND ATTEMPT AT PLACEMENT OF THE RIGHT SIDED ESSURE, BUT SHE COULD NOT TOLERATE THE PROCEDURE. RECEIVED TREATMENT FOR PERFORATION-YES: PERFORATION: UTERUS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED).. IMAGING PROCEDURE - ON (B)(6) 2011: PERFORATION (FALLOPIAN TUBE). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION AND VAGINAL HEMORRHAGE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-SEP-2019: PFS RECEIVED: NEW EVENTS ABDOMINAL PAIN, GENERAL ABNORMAL BLEEDING, UTERUS PERFORATION WERE ADDED. ON 3-SEP-2019: FOLLOW UP 4 AND 5 PROCESSED TOGETHER NO NEW CLINICAL INFORMATION WAS 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 FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBE(S) / RIGHT SIDE') AND DEVICE DISLOCATION ('MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: PERITONEUM/ EPIPLOICA NEAR THE JUNCTION OF THE ILEUM AND CECUM/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: PERITONEUM/ EPIPLOICA NEAR THE JUNCTION OF THE ILEUM AND CECUM') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841532) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED UTERINE DILATION AND CURETTAGE AND MENSTRUATION DELAYED. CONCURRENT CONDITIONS INCLUDED CRAMP IN LOWER ABDOMEN. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL; LEVONORGESTREL (LEVORA) SINCE 2006 TO (B)(6) 2012, HYDROCODONE; PARACETAMOL (ACETAMINOPHEN; HYDROCODONE) SINCE (B)(6) 2012, IBUPROFEN FROM (B)(6) 2012 AND NSAIDS SINCE (B)(6) 2011. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"). ON (B)(6) 2011, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 MONTHS 14 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2012, LAPAROSCOPIC RIGHT TUBAL LIGATION & REMOVAL OF PERFORATED ESSURE DEVICE). AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN AND THE PELVIC PAIN WAS RESOLVING. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: VISIBLE COILS SHOWING WITHIN THE ENDOMETRIAL CAVITY AS FOLLOWS: RIGHT: 3 COILS LEFT: 6 COILS ONLY RIGHT ESSURE REMOVED. THE RIGHT ESSURE DEVICE APPEARED TO BE IN THE PERITONEUM AND THE RIGHT FALLOPIAN TUBE WAS NOT OCCLUDED. THE PATIENT HAD A SECOND ATTEMPT AT PLACEMENT OF THE RIGHT SIDED ESSURE, BUT SHE COULD NOT TOLERATE THE PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED),PERFORATION (FALLOPIAN TUBE). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION AND VAGINAL HEMORRHAGE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-AUG-2019: PFS AND MR RECEIVED- NEW EVENTS¿ PERFORATION (FALLOPIAN TUBE(S) / RIGHT SIDE, MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: PERITONEUM/ EPIPLOICA NEAR THE JUNCTION OF THE ILEUM AND CECUM/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: PERITONEUM/ EPIPLOICA NEAR THE JUNCTION OF THE ILEUM AND CECUM, ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH¿, CONCOMITANT DRUG, MEDICAL HISTORY, LAB DATA, PATIENT DEMOGRAPHIC 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 711646 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841532 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Other| R | ACETAMINOPHEN,HYDROCODONE| ACETAMINOPHEN,HYDROCODONE| ACETAMINOPHEN,HYDROCODONE| ACETAMINOPHEN,HYDROCODONE| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| LEVORA [ETHINYLESTRADIOL,LEVONORGESTREL]| LEVORA [ETHINYLESTRADIOL,LEVONORGESTREL]| LEVORA [ETHINYLESTRADIOL,LEVONORGESTREL]| LEVORA [ETHINYLESTRADIOL,LEVONORGESTREL]| NSAIDS| NSAIDS| NSAIDS| NSAIDS |