Description of Event or Problem · 1
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("ONE ESSURE COIL HAD MIGRATED FROM HER FALLOPIAN TUBES /LEFT MICRO-INSERT WAS NEVER LOCATED"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANT (PREGNANCY (STILLBIRTH OR MISCARRIAGE)"), ABORTION SPONTANEOUS ("BABY DIED IN THE WOMB/PREGNANCY (STILLBIRTH OR MISCARRIAGE)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A (B)(6) YEAR-OLD FEMALE PATIENT (GRAVIDA 2) WHO HAD ESSURE (BATCH NO. 910509) 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". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED BACK PAIN, VAGINAL DISCHARGE, BREAST TENDERNESS AND HEADACHE. CONCURRENT CONDITIONS INCLUDED GRAVIDA II, ACUTE PAIN, HEMORRHAGE, HYPOTHERMIA, SEPSIS AND URINARY RETENTION. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2013 TO (B)(6) 2013. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), DEPRESSION ("DEPRESSION") AND DEVICE EXPULSION ("EXPULSION OF ESSURE DEVICE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") AND PELVIC PAIN ("PELVIC PAIN/PAIN"). IN (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"). IN (B)(6) 2015, 767 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2015, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2016, THE PATIENT EXPERIENCED HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). IN (B)(6) 2016, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), BACK PAIN ("BACK PAIN"), FATIGUE ("FATIGUE") AND POLLAKIURIA ("URINARY FREQUENCY"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (SUCTION,DILATATION AND CURETTAGE). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, PELVIC PAIN, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, BLADDER DISORDER, URINARY TRACT DISORDER, DYSMENORRHOEA, VAGINAL DISCHARGE, VULVOVAGINAL PAIN, BACK PAIN, DEPRESSION, FATIGUE, DEVICE EXPULSION AND POLLAKIURIA OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, BACK PAIN, BLADDER DISORDER, DEPRESSION, DEVICE DISLOCATION, DEVICE EXPULSION, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, PELVIC PAIN, POLLAKIURIA, PREGNANCY WITH CONTRACEPTIVE DEVICE, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION; PREGNANCY TEST URINE - ON (B)(6) 2015: MISCARRIAGE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORD CONFIRMING EVENT PELVIC PAIN, ABDOMINAL PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-OCT-2018: PFS RECEIVED : REPORTER'S INFORMATION WAS ADDED. CONCOMITANT CONDITION, HISTORICAL CONDITION WAS ADDED. ADDED EVENT ABNORMAL BLEEDING(GENERAL), URINARY FREQUENCY. FU8 & FU9 PROCESS TOGETHER. INCIDENT: AT THE TIME OF REPORTING, 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.