Description of Event or Problem · 1
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION BY THE DEVICE/PERFORATION (FALLOPIAN TUBE(S)') AND DEVICE DISLOCATION ('MIGRATION OF THE DEVICE/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: CORNUAL AREA') IN A (B)(6) YEAR OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 932162) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". MEDICAL CONDITIONS: NO TORSION. NO ADNEXAL MASS. NO BLOOD LOSS. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX HIGH, HAEMORRHAGIC OVARIAN CYST, VAGINAL PAIN, UPPER RESPIRATORY INFECTION, VULVOVAGINITIS, SWELLING NOS (FEELS LIKE FULL AND SWOLLEN), VAGINAL DISCHARGE ABNORMALITY, SUPRAPUBIC PAIN AND HYPERTENSION. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN/ PERSISTENT PELVIC PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND BACK PAIN ("LOWER BACK PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON (B)(6) 2012, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 4 MONTHS 1 DAY AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("PERSISTENT BLEEDING"), ABORTION SPONTANEOUS ("MISCARRIAGES"), INFECTION ("INFECTIONS"), MENSTRUAL DISORDER ("MENSTRUAL BLEEDING"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS CHANGES") AND BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS CHANGES") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("MISCARRIAGES"). THE PATIENT WAS TREATED WITH WARFARIN SODIUM (COUMADIN). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, INFECTION, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, DYSMENORRHOEA, WEIGHT INCREASED, FATIGUE, BACK PAIN, URINARY TRACT DISORDER AND BLADDER DISORDER OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, ANXIETY, BACK PAIN, BLADDER DISORDER, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HAEMORRHAGE, INFECTION, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN, BLEEDING, MIGRATION, PERFORATION, BLADDER/ URINARY TRACT PROBLEMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE (B)(6). HYSTEROSALPINGOGRAM ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PPF RECEIVED EVENT " BLADDER OR URINARY PROBLEMS CHANGES" WAS ADDED. REPORTER INFORMATION WAS ADDED. 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.