ESSURE
Report
- Report Number
- 2951250-2017-08477
- Event Type
- Injury
- Date Received
- November 23, 2017
- Report Date
- June 4, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN/ SHARP PAIN") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 816057) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERLIPIDEMIA, MENOMETRORRHAGIA AND GRAND MULTIPARITY. (B)(6) 2011- EXAM IRON, SERUMIRON: VALUE- 28 (LOW) RANGE & UNITS:37-180 UG/ DL HBA1C AND EST AV GLU, BLOOD, HGB A1C: VALUE- 6.4 (HIGH), RANGE & UNITS:4.0-6.0% COMPLETE BLOOD CT W/DIFF MCV: VALUE-75.5 (LOW), RANGE & UNITS: 80 - 100 FL MCH: VALUE-25.4 (LOW), RANGE & UNITS: 26.0-34.0 PG MPV:VALUE-8.4 (LOW), RANGE & UNITS : 9.3-12.5 FL HEAMOGLOBIN:VALUE-11.1 (LOW), RANGE & UNITS : 11.5-16.0 G/DL HEMATOCRIT:VALUE-33.0(LOW), RANGE & UNITS : 35.0-47.0% (B)(6) 2011 EXAM RESULT COMPLETE BLOOD CT W/DIFF MCV: VALUE-75.8 (LOW), RANGE & UNITS: 80 - 100 FL MCH: VALUE-24.8 (LOW), RANGE & UNITS: 26.0-34.0 PG RDW: VALUE- 16.4 (HIGH), RANGE & UNITS:11.5-14.5% MPV:VALUE-8.6 (LOW), RANGE & UNITS : 9.3-12.5 FL HBA1C AND EST AV GLU, BLOOD, HGB A1C: VALUE- 6.6 (HIGH), RANGE & UNITS:4.0-6.0% (B)(6) 2011 COMPLETE BLOOD CT W/DIFF MCV: VALUE-78 (LOW), RANGE & UNITS: 80 - 100 FL RDW: VALUE-15.3 (HIGH), RANGE & UNITS:11.5-14.5% MPV:VALUE-9.2 (LOW), RANGE & UNITS : 9.3-12.5 FL PATIENT DENIES CHEST PAIN WITH EXERTION, DYSPNEA (SHORTNESS OF BREATH), EDEMA, HEADACHE, DIZZINESS, VISUAL SYMPTOMS AND NEUROLOGIC SYMPTOMS SURGICAL PATHOLOGY REPORT: SPECIMEN: UTERUS WITH OR WITHOUT OVARIES/TUBES, NOT FOR TUMOR, UTERUS BILATERAL TUBES FINAL DIAGNOSIS RESULT: UTERUS WITH FALLOPIAN TUBES, HYSTERECTOMY WITH BILATERAL SALPINGECTOMY: -- CERVIX: NEGATIVE FOR DYSPLASIA OR CARCINOMA -- ENDOMETRIUM: BASALIS LEVEL -- MYOMETRIUM: SUPERFICIAL ADENOMYOSIS, TCA -- SEROSA AND LEFT FALLOPIAN TUBE: NO SIGNIFICANT HISTOPATHOLOGIC CHANGE, -- RIGHT FALLOPIAN TUBE: BENIGN PARA TUBAL CYST. CONCURRENT CONDITIONS INCLUDED DIABETES, GENERALIZED ANXIETY DISORDER, HYPERTENSION, MAJOR DEPRESSION, ROTATOR CUFF TENDINITIS, RETINAL MICROANEURYSMS NOS, PROLIFERATIVE DIABETIC RETINOPATHY, IRREGULAR PERIODS, SHOULDER PAIN, JOINT PAIN, RESTLESS LEGS, SNORE, DIZZY, MENORRHAGIA, DYSFUNCTIONAL UTERINE BLEEDING, OVARIAN CYST, PAINFUL PERIODS, SLEEP APNEA, ECZEMA, PRESBYOPIA, ASTIGMATISM, RETINAL ANOMALY CONGENITAL, MYOPIA, RETINAL SCAR, ADENOMYOSIS, PARATUBAL CYST AND IRON DEFICIENCY ANEMIA. CONCOMITANT PRODUCTS INCLUDED CITALOPRAM, LOSARTAN, METFORMIN AND SITAGLIPTIN PHOSPHATE (JANUVIA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)/EXCESSIVE BLEEDING"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), RASH ("RASH ON ARM"), ALOPECIA ("HAIR LOSS"), ANAEMIA ("ANEMIA"), FATIGUE ("FATIGUE,") AND ABDOMINAL PAIN LOWER ("SEVERE CRAMPING/ LOWER SIDES INSIDE PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, RASH, ALOPECIA, ANAEMIA, FATIGUE AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANAEMIA, FATIGUE, MENORRHAGIA, PELVIC PAIN, RASH AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS - 5 COILS SEEN ON THE LEFT TUBE AND 7 COILS SEEN ON RIGHT TUBE DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION IMPRESSION: POST ESSURE STERILIZATION PROCEDURE WITH NO CONTRAST EXTENDING INTO EITHER FALLOPIAN TUBE. ULTRASOUND SCAN - ON (B)(6) 2017: UTERUS WITHOUT FIBROIDS BILATERAL ESSURE COILS SEEN. RIGHT OVARY NORMAL LEFT OVARY WITH A SIMPLE CYST VS FOLLICLE MEASURING 2.4 X 2.4 X 2.2 CM. FREE FLUID: TRACE SONOHYSTOGRAM NEGATIVE FOR POLYP OR FIBROID. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ANEMIA, FATIGUE, VAGINAL HAEMORRHAGE, MENORRHAGIA, RASH, PELVIC PAIN, ALOPECIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-FEB-2019: PFS+MR RECEIVED- LOT NUMBER WERE ADDED. NEW EVENTS ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), RASH ON ARM, ANEMIA, FATIGUE, HAIR LOSS, SEVERE CRAMPING WERE ADDED. OUTCOME OF PELVIC PAIN UPDATED TO RECOVERED / RESOLVED. NEW REPORTERS, PATIENT INFORMATION, CONCOMITANT DRUGS, MEDICAL HISTORY AND LAB DATA 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN/ SHARP PAIN') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 816057) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERLIPIDEMIA, MENOMETRORRHAGIA AND GRAND MULTIPARITY. (B)(6) 2011. EXAM IRON, SERUMIRON: VALUE- 28 (LOW) RANGE & UNITS:37-180 UG/ DL HBA1C AND EST AV GLU, BLOOD, HGB A1C: VALUE- 6.4 (HIGH), RANGE & UNITS:4.0-6.0% COMPLETE BLOOD CT W/DIFF MCV: VALUE-75.5 (LOW), RANGE & UNITS: 80 - 100 FL MCH: VALUE-25.4 (LOW), RANGE & UNITS: 26.0-34.0 PG MPV:VALUE-8.4 (LOW), RANGE & UNITS : 9.3-12.5 FL HEAMOGLOBIN:VALUE-11.1 (LOW), RANGE & UNITS : 11.5-16.0 G/DL HEMATOCRIT:VALUE-33.0(LOW), RANGE & UNITS : 35.0-47.0% ON (B)(6) 2011, EXAM RESULT COMPLETE BLOOD CT W/DIFF MCV: VALUE-75.8 (LOW), RANGE & UNITS: 80 - 100 FL MCH: VALUE-24.8 (LOW), RANGE & UNITS: 26.0-34.0 PG RDW: VALUE- 16.4 (HIGH), RANGE & UNITS:11.5-14.5% MPV:VALUE-8.6 (LOW), RANGE & UNITS : 9.3-12.5 FL HBA1C AND EST AV GLU, BLOOD, HGB A1C: VALUE- 6.6 (HIGH), RANGE & UNITS:4.0-6.0%. ON (B)(6) 2011, COMPLETE BLOOD CT W/DIFF MCV: VALUE-78 (LOW), RANGE & UNITS: 80 - 100 FL RDW: VALUE-15.3 (HIGH), RANGE & UNITS:11.5-14.5% MPV:VALUE-9.2 (LOW), RANGE & UNITS : 9.3-12.5 FL. PATIENT DENIES CHEST PAIN WITH EXERTION, DYSPNEA (SHORTNESS OF BREATH), EDEMA, HEADACHE, DIZZINESS, VISUAL SYMPTOMS AND NEUROLOGIC SYMPTOMS SURGICAL PATHOLOGY REPORT: SPECIMEN: UTERUS WITH OR WITHOUT OVARIES/TUBES, NOT FOR TUMOR, UTERUS BILATERAL TUBES FINAL DIAGNOSIS RESULT: UTERUS WITH FALLOPIAN TUBES, HYSTERECTOMY WITH BILATERAL SALPINGECTOMY: CERVIX: NEGATIVE FOR DYSPLASIA OR CARCINOMA ENDOMETRIUM: BASALIS LEVEL MYOMETRIUM: SUPERFICIAL ADENOMYOSIS, TCA SEROSA AND LEFT FALLOPIAN TUBE: NO SIGNIFICANT HISTOPATHOLOGIC CHANGE, RIGHT FALLOPIAN TUBE: BENIGN PARA TUBAL CYST. CONCURRENT CONDITIONS INCLUDED DIABETES, GENERALIZED ANXIETY DISORDER, HYPERTENSION, MAJOR DEPRESSION, ROTATOR CUFF TENDINITIS, RETINAL MICROANEURYSMS NOS, PROLIFERATIVE DIABETIC RETINOPATHY, IRREGULAR PERIODS, SHOULDER PAIN, JOINT PAIN, RESTLESS LEGS, SNORE, DIZZY, MENORRHAGIA, DYSFUNCTIONAL UTERINE BLEEDING, OVARIAN CYST, PAINFUL PERIODS, SLEEP APNEA, ECZEMA, PRESBYOPIA, ASTIGMATISM, RETINAL ANOMALY CONGENITAL, MYOPIA, RETINAL SCAR, ADENOMYOSIS, PARATUBAL CYST AND IRON DEFICIENCY ANEMIA. CONCOMITANT PRODUCTS INCLUDED CITALOPRAM, LOSARTAN, METFORMIN AND SITAGLIPTIN PHOSPHATE (JANUVIA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)/EXCESSIVE BLEEDING"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), RASH ("RASH ON ARM"), ALOPECIA ("HAIR LOSS"), ANAEMIA ("ANEMIA"), FATIGUE ("FATIGUE,") AND ABDOMINAL PAIN LOWER ("SEVERE CRAMPING/ LOWER SIDES INSIDE PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED RASH PAPULAR ("RASHES OR SKIN CONDITIONS TYPE: RED BUMPS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, RASH, ALOPECIA, ANAEMIA, FATIGUE AND ABDOMINAL PAIN LOWER HAD RESOLVED AND THE RASH PAPULAR OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANAEMIA, FATIGUE, MENORRHAGIA, PELVIC PAIN, RASH, RASH PAPULAR AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS - 5 COILS SEEN ON THE LEFT TUBE AND 7 COILS SEEN ON RIGHT TUBE DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. IMPRESSION: POST ESSURE STERILIZATION PROCEDURE WITH NO CONTRAST EXTENDING INTO EITHER FALLOPIAN TUBE. ULTRASOUND SCAN - ON (B)(6) 2017: UTERUS WITHOUT FIBROIDS BILATERAL ESSURE COILS SEEN. RIGHT OVARY NORMAL LEFT OVARY WITH A SIMPLE CYST VS FOLLICLE MEASURING 2.4 X 2.4 X 2.2 CM. FREE FLUID: TRACE SONOHYSTOGRAM NEGATIVE FOR POLYP OR FIBROID. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ANEMIA, FATIGUE, VAGINAL HAEMORRHAGE, MENORRHAGIA, RASH, PELVIC PAIN, ALOPECIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-MAY-2019: PFS RECEIVED: EVENT RASHES OR SKIN CONDITIONS TYPE: RED BUMPS 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN/ SHARP PAIN") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 816057) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERLIPIDEMIA, MENOMETRORRHAGIA AND GRAND MULTIPARITY. (B)(6) 2011- EXAM IRON, SERUMIRON: VALUE- 28 (LOW) RANGE & UNITS:37-180 UG/ DL HBA1C AND EST AV GLU, BLOOD, HGB A1C: VALUE- 6.4 (HIGH), RANGE & UNITS:4.0-6.0% COMPLETE BLOOD CT W/DIFF MCV: VALUE-75.5 (LOW), RANGE & UNITS: 80 - 100 FL MCH: VALUE-25.4 (LOW), RANGE & UNITS: 26.0-34.0 PG MPV:VALUE-8.4 (LOW), RANGE & UNITS : 9.3-12.5 FL HEAMOGLOBIN:VALUE-11.1 (LOW), RANGE & UNITS : 11.5-16.0 G/DL HEMATOCRIT:VALUE-33.0(LOW), RANGE & UNITS : 35.0-47.0% (B)(6) 2011 EXAM RESULT COMPLETE BLOOD CT W/DIFF MCV: VALUE-75.8 (LOW), RANGE & UNITS: 80 - 100 FL MCH: VALUE-24.8 (LOW), RANGE & UNITS: 26.0-34.0 PG RDW: VALUE- 16.4 (HIGH), RANGE & UNITS:11.5-14.5% MPV:VALUE-8.6 (LOW), RANGE & UNITS : 9.3-12.5 FL HBA1C AND EST AV GLU, BLOOD, HGB A1C: VALUE- 6.6 (HIGH), RANGE & UNITS:4.0-6.0% (B)(6) 2011 COMPLETE BLOOD CT W/DIFF MCV: VALUE-78 (LOW), RANGE & UNITS: 80 - 100 FL RDW: VALUE-15.3 (HIGH), RANGE & UNITS:11.5-14.5% MPV:VALUE-9.2 (LOW), RANGE & UNITS : 9.3-12.5 FL PATIENT DENIES CHEST PAIN WITH EXERTION, DYSPNEA (SHORTNESS OF BREATH), EDEMA, HEADACHE, DIZZINESS, VISUAL SYMPTOMS AND NEUROLOGIC SYMPTOMS SURGICAL PATHOLOGY REPORT: SPECIMEN: UTERUS WITH OR WITHOUT OVARIES/TUBES, NOT FOR TUMOR, UTERUS BILATERAL TUBES FINAL DIAGNOSIS RESULT: UTERUS WITH FALLOPIAN TUBES, HYSTERECTOMY WITH BILATERAL SALPINGECTOMY: -- CERVIX: NEGATIVE FOR DYSPLASIA OR CARCINOMA -- ENDOMETRIUM: BASALIS LEVEL -- MYOMETRIUM: SUPERFICIAL ADENOMYOSIS, TCA -- SEROSA AND LEFT FALLOPIAN TUBE: NO SIGNIFICANT HISTOPATHOLOGIC CHANGE, -- RIGHT FALLOPIAN TUBE: BENIGN PARA TUBAL CYST. CONCURRENT CONDITIONS INCLUDED DIABETES, GENERALIZED ANXIETY DISORDER, HYPERTENSION, MAJOR DEPRESSION, ROTATOR CUFF TENDINITIS, RETINAL MICROANEURYSMS NOS, PROLIFERATIVE DIABETIC RETINOPATHY, IRREGULAR PERIODS, SHOULDER PAIN, JOINT PAIN, RESTLESS LEGS, SNORE, DIZZY, MENORRHAGIA, DYSFUNCTIONAL UTERINE BLEEDING, OVARIAN CYST, PAINFUL PERIODS, SLEEP APNEA, ECZEMA, PRESBYOPIA, ASTIGMATISM, RETINAL ANOMALY CONGENITAL, MYOPIA, RETINAL SCAR, ADENOMYOSIS, PARATUBAL CYST AND IRON DEFICIENCY ANEMIA. CONCOMITANT PRODUCTS INCLUDED CITALOPRAM, LOSARTAN, METFORMIN AND SITAGLIPTIN PHOSPHATE (JANUVIA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)/EXCESSIVE BLEEDING"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), RASH ("RASH ON ARM"), ALOPECIA ("HAIR LOSS"), ANAEMIA ("ANEMIA"), FATIGUE ("FATIGUE,") AND ABDOMINAL PAIN LOWER ("SEVERE CRAMPING/ LOWER SIDES INSIDE PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, RASH, ALOPECIA, ANAEMIA, FATIGUE AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANAEMIA, FATIGUE, MENORRHAGIA, PELVIC PAIN, RASH AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS - 5 COILS SEEN ON THE LEFT TUBE AND 7 COILS SEEN ON RIGHT TUBE DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON 1(B)(6) 2011: TOTAL BILATERAL OCCLUSION IMPRESSION: POST ESSURE STERILIZATION PROCEDURE WITH NO CONTRAST EXTENDING INTO EITHER FALLOPIAN TUBE. ULTRASOUND SCAN - ON (B)(6) 2017: UTERUS WITHOUT FIBROIDS BILATERAL ESSURE COILS SEEN. RIGHT OVARY NORMAL LEFT OVARY WITH A SIMPLE CYST VS FOLLICLE MEASURING 2.4 X 2.4 X 2.2 CM. FREE FLUID: TRACE SONOHYSTOGRAM NEGATIVE FOR POLYP OR FIBROID. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ANEMIA, FATIGUE, VAGINAL HAEMORRHAGE, MENORRHAGIA, RASH, PELVIC PAIN, ALOPECIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-MAR-2019: QUALITY SAFETY EVALUATION OF PTC. 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 PELVIC PAIN ("PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. IN 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED IN (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 835071 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 816057 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other| R | CITALOPRAM| CITALOPRAM| CITALOPRAM| JANUVIA| JANUVIA| JANUVIA| LOSARTAN| LOSARTAN| LOSARTAN| METFORMIN| METFORMIN| METFORMIN |