ESSURE
Report
- Report Number
- 2951250-2019-06421
- Event Type
- Injury
- Date Received
- September 13, 2019
- Date of Event
- September 13, 2013
- Report Date
- November 6, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- 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 BREAKAGE ('BREAKAGE/ EXPULSION: BREAKAGE'), DEVICE EXPULSION ('MIGRATION/ MIGRATION OF ESSURE DEVICE- LOCATION OF DEVICE: UTERUS') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910515) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED POLYCYSTIC OVARIAN SYNDROME. CONCURRENT CONDITIONS INCLUDED DEPRESSION, HYPERTENSION, TYPE 2 DIABETES MELLITUS, UMBILICAL BLEEDING, NAUSEA, GRANULOMA, UMBILICAL HERNIA, UTERINE FIBROIDS AND UTERINE ENLARGEMENT. CONCOMITANT PRODUCTS INCLUDED FLUOXETINE FROM (B)(6) 2010 TO (B)(6) 2013 FOR DEPRESSION, LOSARTAN FROM (B)(6) 2013 TO (B)(6) 2017 FOR HYPERTENSION, METFORMIN FROM (B)(6) 2011 TO (B)(6) 2017 FOR TYPE 2 DIABETES MELLITUS AS WELL AS ACICLOVIR (ACYCLOVIR) FROM (B)(6) 2012 TO (B)(6) 2017, ATORVASTATIN FROM (B)(6) 2013 TO (B)(6) 2017, CETIRIZINE HYDROCHLORIDE (CETRIZINE) FROM (B)(6) 2013 TO (B)(6) 2016, DICLOFENAC FROM (B)(6) 2017 TO (B)(6) 2017, ETHINYLESTRADIOL;FERROUS FUMARATE;NORETHISTERONE ACETATE (JUNEL FE) FROM (B)(6) 2017 TO (B)(6) 2019, ETHINYLESTRADIOL;NORGESTIMATE (ORTHO TRI-CYCLEN), KETOROLAC, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA), NAPROXEN FROM (B)(6) 2012 TO (B)(6) 2017, ONDANSETRON (ZOFRAN MELT), TRAMADOL FROM (B)(6) 2017 TO (B)(6) 2017 AND TROMETAMOL (TROMETHAMINE). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN, PELVIC/ PAIN PELVIC AREA"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("PSYCH INJURY/ PSYCHOLOGICAL OR PSYCHAITRIC PROBLEMS- CONDITION: DEPRESSION") AND ANXIETY ("PSYCH INJURY/ PSYCHOLOGICAL OR PSYCHAITRIC PROBLEMS- CONDITION: MENTAL ANGUISH"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 11 MONTHS 23 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2018, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND BACK PAIN ("LOWER BACK AREA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL),SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE EXPULSION, DEPRESSION, VAGINAL HAEMORRHAGE AND ANXIETY OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA AND MENORRHAGIA HAD RESOLVED AND THE BACK PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DEVICE BREAKAGE, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN. MENORRHAGIA (HEAVY MENSTRUAL BLEEDING),GENERAL ABNORMAL BLEEDING, DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), DEVICE BREAKAGE, MIGRATION. THE LEFT TUBAL OSTIA WAS CANNULATED, AND WITH DEPLOYMENT OF THE DEVICE 3 COILS COULD BE SEEN. THE RIGHT TUBAL OSTIA WAS CANNULATED AND AFTER DEPLOYMENT, 4 COILS COULD BE SEEN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED IMPRESSION: BILATERAL ESSURE DEVICES IN EXPECTED LOCATION WITH CONFIRMATION OF BILATERAL TUBAL OCCLUSION.. PATHOLOGY TEST - ON (B)(6) 2019: UTERUS WITH CERVIX AND BILATERAL FALLOPIAN TUBES: UTERINE WEIGHT 106 GRAMS. WEAKLY PROLIFERATIVE ENDOMETRIUM WITH STROMAL PREDECIDUALIZATION. INTRAMURAL LEIOMYOMATA X 2, 0.7 AND 0.4 CM IN GREATEST DIMENSION. CERVIX, UTERINE SEROSA, AND FALLOPIAN TUBES WITHOUT PATHOLOGIC ABNORMALITY.. ULTRASOUND SCAN - ON (B)(6) 2018: THE RIGHT SIDED ESSURE DEVICE IS SEEN AT THE RIGHT LATERAL FUNDUS. THE APPEARANCE ON THE LEFT IS DIFFERENT. THERE IS A TINY ECHOGENIC STRUCTURE WITH APPEARANCE OF THE DEVICE AT THE LEFT LATERAL FUNDUS, THERE IS ALSO A MUCH LONGER STRUCTURE OF THE SAME APPEARANCE AND NEARLY SAME LENGTH OF THE RIGHT SIDED DEVICE AND THIS SECOND DEVICE IS SEEN WITHIN OR ALONGSIDE OF THE MEC IN THE REGION OF THE UT (AS WRITTEN) BODY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ABDOMINAL PAIN, DYSPAREUNIA, DYSMENORRHEA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-OCT-2019: PFS AND MR RECEIVED. LOT NUMBER RECEIVED. NEW EVENTS: ABNORMAL BLEEDING (VAGINAL), PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: MENTAL ANGUISH, BACK PAIN WERE ADDED. MIGRATION OF DEVICE WAS UPDATED TO EXPULSION OF DEVICE, PSYCH INJURY WAS UPDATED TO PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION. ONSET DATES WERE ADDED. CONCOMITANT CONDITIONS AND DRUGS WERE ADDED. NEW REPORTERS AND PLAINTIFFS INFORMATION ADDED. LAB DATA 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 BREAKAGE ('BREAKAGE/ EXPULSION: BREAKAGE'), DEVICE DISLOCATION ('MIGRATION') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PHYSICAL PAIN, PELVIC"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL),SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA AND MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN. MENORRHAGIA (HEAVY MENSTRUAL BLEEDING),GENERAL ABNORMAL BLEEDING, DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), DEVICE BREAKAGE, MIGRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: QUALITY-SAFETY EVALUATION OF PTC. INCIDENT NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE AND OTHER NON-CONFORMANCE'S DATA; SHOULD ANY NEW AND REPORTABLE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('BREAKAGE/ EXPULSION: BREAKAGE'), DEVICE EXPULSION ('MIGRATION/ MIGRATION OF ESSURE DEVICE- LOCATION OF DEVICE: UTERUS') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910515) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED POLYCYSTIC OVARIAN SYNDROME. CONCURRENT CONDITIONS INCLUDED DEPRESSION, HYPERTENSION, TYPE 2 DIABETES MELLITUS, UMBILICAL BLEEDING, NAUSEA, GRANULOMA, UMBILICAL HERNIA, UTERINE FIBROIDS AND UTERINE ENLARGEMENT. CONCOMITANT PRODUCTS INCLUDED FLUOXETINE FROM (B)(6) 2010 TO (B)(6) 2013 FOR DEPRESSION, LOSARTAN FROM (B)(6) 2013 TO (B)(6) 2017 FOR HYPERTENSION, METFORMIN FROM (B)(6) 2011 TO (B)(6)2017 FOR TYPE 2 DIABETES MELLITUS AS WELL AS ACICLOVIR (ACYCLOVIR) FROM (B)(6) 2012 TO (B)(6)2017, ATORVASTATIN FROM (B)(6) 2013 TO (B)(6) 2017, CETIRIZINE HYDROCHLORIDE (CETRIZINE) FROM (B)(6) 2013 TO (B)(6) 2016, DICLOFENAC FROM (B)(6) 2017 TO (B)(6) 2017, ETHINYLESTRADIOL;FERROUS FUMARATE;NORETHISTERONE ACETATE (JUNEL FE) FROM (B)(6) 2017 TO (B)(6) 2019, ETHINYLESTRADIOL;NORGESTIMATE (ORTHO TRI-CYCLEN), KETOROLAC, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA), NAPROXEN FROM (B)(6) 2012 TO (B)(6) 2017, ONDANSETRON (ZOFRAN MELT), TRAMADOL FROM (B)(6) 2017 TO (B)(6) 2017 AND TROMETAMOL (TROMETHAMINE). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN, PELVIC/ PAIN PELVIC AREA"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("PSYCH INJURY/ PSYCHOLOGICAL OR PSYCHAITRIC PROBLEMS- CONDITION: DEPRESSION") AND ANXIETY ("PSYCH INJURY/ PSYCHOLOGICAL OR PSYCHAITRIC PROBLEMS- CONDITION: MENTAL ANGUISH"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 11 MONTHS 23 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2018, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND BACK PAIN ("LOWER BACK AREA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL),SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6)2019. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE EXPULSION, DEPRESSION, VAGINAL HAEMORRHAGE AND ANXIETY OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA AND MENORRHAGIA HAD RESOLVED AND THE BACK PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DEVICE BREAKAGE, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN. MENORRHAGIA (HEAVY MENSTRUAL BLEEDING),GENERAL ABNORMAL BLEEDING, DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), DEVICE BREAKAGE, MIGRATION. THE LEFT TUBAL OSTIA WAS CANNULATED, AND WITH DEPLOYMENT OF THE DEVICE 3 COILS COULD BE SEEN. THE RIGHT TUBAL OSTIA WAS CANNULATED AND AFTER DEPLOYMENT, 4 COILS COULD BE SEEN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED IMPRESSION: BILATERAL ESSURE DEVICES IN EXPECTED LOCATION WITH CONFIRMATION OF BILATERAL TUBAL OCCLUSION.. PATHOLOGY TEST - ON (B)(6) 2019: UTERUS WITH CERVIX AND BILATERAL FALLOPIAN TUBES: UTERINE WEIGHT 106 GRAMS. WEAKLY PROLIFERATIVE ENDOMETRIUM WITH STROMAL PREDECIDUALIZATION. INTRAMURAL LEIOMYOMATA X 2, 0.7 AND 0.4 CM IN GREATEST DIMENSION. CERVIX, UTERINE SEROSA, AND FALLOPIAN TUBES WITHOUT PATHOLOGIC ABNORMALITY.. ULTRASOUND SCAN - ON (B)(6) 2018: THE RIGHT SIDED ESSURE DEVICE IS SEEN AT THE RIGHT LATERAL FUNDUS. THE APPEARANCE ON THE LEFT IS DIFFERENT. THERE IS A TINY ECHOGENIC STRUCTURE WITH APPEARANCE OF THE DEVICE AT THE LEFT LATERAL FUNDUS, THERE IS ALSO A MUCH LONGER STRUCTURE OF THE SAME APPEARANCE AND NEARLY SAME LENGTH OF THE RIGHT SIDED DEVICE AND THIS SECOND DEVICE IS SEEN WITHIN OR ALONGSIDE OF THE MEC IN THE REGION OF THE UT (AS WRITTEN) BODY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ABDOMINAL PAIN, DYSPAREUNIA, DYSMENORRHEA. 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. 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 BREAKAGE ('BREAKAGE/ EXPULSION: BREAKAGE'), DEVICE DISLOCATION ('MIGRATION') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PHYSICAL PAIN, PELVIC"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL),SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA AND MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN. MENORRHAGIA (HEAVY MENSTRUAL BLEEDING),GENERAL ABNORMAL BLEEDING, DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), DEVICE BREAKAGE, MIGRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-SEP-2019: PFS RECEIVED-REPORTER INFORMATION, PATIENT DEMOGRAPHICS, ESSURE REMOVAL DATE WAS ADDED. NEW EVENTS ADDED ABDOMINAL PAIN. MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GENERAL ABNORMAL BLEEDING, DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), DEVICE BREAKAGE, MIGRATION, PSYCH INJURY. EVENT OUTCOME ADDED ABDOMINAL PAIN. MENORRHAGIA (HEAVY MENSTRUAL BLEEDING),GENERAL ABNORMAL BLEEDING, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC PAIN. LAB TEST DATE UPDATED. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 821350 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 910515 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other| R | ACYCLOVIR [ACICLOVIR]| ACYCLOVIR [ACICLOVIR]| ATORVASTATIN| ATORVASTATIN| CETRIZINE| CETRIZINE| DEPO-PROVERA| DEPO-PROVERA| DICLOFENAC| DICLOFENAC| FLUOXETINE| FLUOXETINE| JUNEL FE| JUNEL FE| KETOROLAC| KETOROLAC| LOSARTAN| LOSARTAN| METFORMIN| METFORMIN| NAPROXEN| NAPROXEN| ORTHO TRI-CYCLEN| ORTHO TRI-CYCLEN| TRAMADOL| TRAMADOL| TROMETHAMINE| TROMETHAMINE| ZOFRAN MELT| ZOFRAN MELT |