ESSURE
Report
- Report Number
- 2951250-2019-10745
- Event Type
- Injury
- Date Received
- October 25, 2019
- Report Date
- May 25, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ENDOMETRITIS ('UNSPECIFIED INFLAMMATORY DISEASE OF UTERUS') IN A 21-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952114) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED RHEUMATOID ARTHRITIS. CONCURRENT CONDITIONS INCLUDED HYPERTENSION, MENSTRUAL DISORDER, ANEMIA, ENDOMETRIOSIS, OTHER DISORDERS OF INTESTINE, VAGINAL DISCHARGE, DIARRHEA, GONORRHEA, ITCHING, FATIGUE, SLEEP DISTURBANCE, UTERINE BLEEDING, BACK PAIN AND MENSES IRREGULAR WITH EXCESSIVE BLEEDING. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORGESTIMATE (NORGESTIMATE & ETHINYL ESTRADIOL) FROM (B)(6) 2018 TO (B)(6) 2018, ETHINYLESTRADIOL;NORGESTIMATE (SPRINTEC) FROM (B)(6) 2018 TO (B)(6) 2018, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2012 TO (B)(6) 2013, NSAIDS SINCE (B)(6) 2012 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN/ INCREASINGLY SEVERE PAIN/ CHRONIC PELVIC PAIN"), HEAVY MENSTRUAL BLEEDING ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING (MENORRHAGIA)"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT") AND DEPRESSION ("PSYCH INJURY/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE ("GEN. ABNORMAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), URINARY TRACT DISORDER ("BLADDER/URINARY PROBLEMS: URINARY PROBLEMS"), MEDICAL DEVICE DISCOMFORT ("DISCOMFORT"), BACK PAIN ("CHRONIC BACK PAIN"), ABDOMINAL DISTENSION ("ABDOMINAL BLOATING"), ALOPECIA ("EXCESSIVE HAIR LOSS") AND ABNORMAL WEIGHT GAIN ("EXCESSIVE WEIGHT GAIN"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE ENDOMETRITIS, GENITAL HAEMORRHAGE, DYSMENORRHOEA, ANXIETY, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION AND DEPRESSION OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, ABDOMINAL PAIN, HEAVY MENSTRUAL BLEEDING, MEDICAL DEVICE DISCOMFORT, BACK PAIN, ABDOMINAL DISTENSION, ALOPECIA AND ABNORMAL WEIGHT GAIN HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABNORMAL WEIGHT GAIN, ALOPECIA, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, ENDOMETRITIS, GENITAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, MEDICAL DEVICE DISCOMFORT, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2018- SHE PERFORMED DILATION AND CURETTAGE SURGERY. INSERTION DETAILS:- RIGHT 2 COILS, THE ESSURE WAS THEN INTRODUCED INTO THE FALLOPIAN TUBE AND IT WAS DEPLOYED WITHOUT DIFFICULTY LEAVING 3 COILS IN THE ENDOMETRIAL CAVITY. DATE OF INSERTION: (B)(6) 2013. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED; ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, DYSMENORRHEA, ABDOMINAL PAIN, VAGINAL BLEEDING, UTI LOT NUMBER: 952114 MANUFACTURE DATE: 2012-02 EXPIRATION DATE: 2015-02. QUALITY-SAFETY EVALUATION OF PTC: 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-MAY-2021: QUALITY SAFETY EVALUATION OF PTC. 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 ENDOMETRITIS ('UNSPECIFIED INFLAMMATORY DISEASE OF UTERUS') AND GENITAL HAEMORRHAGE ('GEN. ABNORMAL BLEEDING') IN A 21-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 952114) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED HYPERTENSION, MENSTRUAL DISORDER, ANEMIA, ENDOMETRIOSIS, OTHER DISORDERS OF INTESTINE, VAGINAL DISCHARGE, DIARRHEA, GONORRHEA, ITCHING, FATIGUE, SLEEP DISTURBANCE, UTERINE BLEEDING, BACK PAIN AND MENSES IRREGULAR WITH EXCESSIVE BLEEDING. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORGESTIMATE (NORGESTIMATE & ETHINYL ESTRADIOL) FROM ON (B)(6) 2018, ETHINYLESTRADIOL;NORGESTIMATE (SPRINTEC) FROM ON (B)(6) 2018, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM ON (B)(6) 2012 TO ON (B)(6) 2013, NSAIDS SINCE ON (B)(6) 2012 AND PARACETAMOL (ACETAMINOPHEN) SINCE ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING (MENORRHAGIA"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT") AND DEPRESSION ("PSYCH INJURY/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND URINARY TRACT DISORDER ("BLADDER/URINARY PROBLEMS: URINARY PROBLEMS"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE ENDOMETRITIS, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, ANXIETY, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, ENDOMETRITIS, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2018, SHE PERFORMED DILATION AND CURETTAGE SURGERY. INSERTION DETAILS: RIGHT 2 COILS, THE ESSURE WAS THEN INTRODUCED INTO THE FALLOPIAN TUBE AND IT WAS DEPLOYED WITHOUT DIFFICULTY LEAVING 3 COILS IN THE ENDOMETRIAL CAVITY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM: ON AN UNKNOWN DATE: THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED; ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, DYSMENORRHEA, ABDOMINAL PAIN, VAGINAL BLEEDING, UTI. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-OCT-2019: QUALITY-SAFETY EVALUATION OF 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 ENDOMETRITIS ('UNSPECIFIED INFLAMMATORY DISEASE OF UTERUS') IN A 21-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952114) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED RHEUMATOID ARTHRITIS. CONCURRENT CONDITIONS INCLUDED HYPERTENSION, MENSTRUAL DISORDER, ANEMIA, ENDOMETRIOSIS, OTHER DISORDERS OF INTESTINE, VAGINAL DISCHARGE, DIARRHEA, GONORRHEA, ITCHING, FATIGUE, SLEEP DISTURBANCE, UTERINE BLEEDING, BACK PAIN AND MENSES IRREGULAR WITH EXCESSIVE BLEEDING. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORGESTIMATE (NORGESTIMATE & ETHINYL ESTRADIOL) FROM (B)(6) 2018 TO (B)(6) 2018, ETHINYLESTRADIOL;NORGESTIMATE (SPRINTEC) FROM (B)(6) 2018 TO (B)(6) 2018, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2012 TO (B)(6) 2013, NSAIDS SINCE (B)(6) 2012 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN/ INCREASINGLY SEVERE PAIN/ CHRONIC PELVIC PAIN"), HEAVY MENSTRUAL BLEEDING ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING (MENORRHAGIA)"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT") AND DEPRESSION ("PSYCH INJURY/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE ("GEN. ABNORMAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), URINARY TRACT DISORDER ("BLADDER/URINARY PROBLEMS: URINARY PROBLEMS"), MEDICAL DEVICE DISCOMFORT ("DISCOMFORT"), BACK PAIN ("CHRONIC BACK PAIN"), ABDOMINAL DISTENSION ("ABDOMINAL BLOATING"), ALOPECIA ("EXCESSIVE HAIR LOSS") AND ABNORMAL WEIGHT GAIN ("EXCESSIVE WEIGHT GAIN"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE ENDOMETRITIS, GENITAL HAEMORRHAGE, DYSMENORRHOEA, ANXIETY, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION AND DEPRESSION OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, ABDOMINAL PAIN, HEAVY MENSTRUAL BLEEDING, MEDICAL DEVICE DISCOMFORT, BACK PAIN, ABDOMINAL DISTENSION, ALOPECIA AND ABNORMAL WEIGHT GAIN HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABNORMAL WEIGHT GAIN, ALOPECIA, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, ENDOMETRITIS, GENITAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, MEDICAL DEVICE DISCOMFORT, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2018- SHE PERFORMED DILATION AND CURETTAGE SURGERY. INSERTION DETAILS: RIGHT 2 COILS, THE ESSURE WAS THEN INTRODUCED INTO THE FALLOPIAN TUBE AND IT WAS DEPLOYED WITHOUT DIFFICULTY LEAVING 3 COILS IN THE ENDOMETRIAL CAVITY. DATE OF INSERTION: (B)(6) 2013. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED; ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, DYSMENORRHEA, ABDOMINAL PAIN, VAGINAL BLEEDING, UTI. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-APR-2021: THIS IS RETENTION CASE. ALL RELEVANT INFORMATION FROM DELETION (B)(4) IS TRANSFERRED TO THIS CASE. REPORTER INFORMATION ADDED. EVENTS: DISCOMFORT, CHRONIC BACK PAIN, ABDOMINAL BLOATING, EXCESSIVE HAIR LOSS, EXCESSIVE WEIGHT GAIN ADDED. EVENT OUTCOME, RCC 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 REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ENDOMETRITIS ('UNSPECIFIED INFLAMMATORY DISEASE OF UTERUS') AND GENITAL HAEMORRHAGE ('GEN. ABNORMAL BLEEDING') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952114) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED HYPERTENSION, MENSTRUAL DISORDER NOS, ANEMIA, ENDOMETRIOSIS, OTHER DISORDERS OF INTESTINE, VAGINAL DISCHARGE, DIARRHEA, GONORRHEA, ITCHING, FATIGUE, SLEEP DISTURBANCE, UTERINE BLEEDING, BACK PAIN AND MENSES IRREGULAR WITH EXCESSIVE BLEEDING. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORGESTIMATE (NORGESTIMATE & ETHINYL ESTRADIOL) FROM (B)(6) 2018 TO (B)(6) 2018, ETHINYLESTRADIOL;NORGESTIMATE (SPRINTEC) FROM (B)(6) 2018 TO (B)(6) 2018, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2012 TO (B)(6) 2013, NSAIDS SINCE (B)(6) 2012 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING (MENORRHAGIA)"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT") AND DEPRESSION ("PSYCH INJURY/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND URINARY TRACT DISORDER ("BLADDER/URINARY PROBLEMS: URINARY PROBLEMS"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE ENDOMETRITIS, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, ANXIETY, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, ENDOMETRITIS, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2018 SHE PERFORMED DILATION AND CURETTAGE SURGERY. INSERTION DETAILS:- RIGHT 2 COILS, THE ESSURE WAS THEN INTRODUCED INTO THE FALLOPIAN TUBE AND IT WAS DEPLOYED WITHOUT DIFFICULTY LEAVING 3 COILS IN THE ENDOMETRIAL CAVITY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED; ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, DYSMENORRHEA, ABDOMINAL PAIN, VAGINAL BLEEDING, UTI MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-OCT-2019: PLAINTIFF FACT SHEET AND MEDICAL RECORD WAS RECEIVED. LOT NUMBER WERE ADDED. EVENTS ADDED FROM PFS- ABNORMAL BLEEDING (VAGINAL), MENTAL ANGUISH. PREVIOUSLY REPORTED EVENT-PSYCHOLOGICAL TRAUMA UPDATED TO EVENT-DEPRESSION. REPORTER INFORMATION, MEDICAL HISTORY, CONCOMITANT DRUG, EVENTS ONSET DATE WERE 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1031290 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 952114 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| NORGESTIMATE & ETHINYL ESTRADIOL| NORGESTIMATE & ETHINYL ESTRADIOL| NORGESTIMATE & ETHINYL ESTRADIOL| NORGESTIMATE & ETHINYL ESTRADIOL| NSAIDS| NSAIDS| NSAIDS| NSAIDS| SPRINTEC| SPRINTEC| SPRINTEC| SPRINTEC |