Description of Event or Problem · 1
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802744) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OVERWEIGHT AND DEPRESSION. CONCOMITANT PRODUCTS INCLUDED FLUOXETINE HYDROCHLORIDE (PROZAC) FROM 2013 TO 2015 AND OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET) FROM 2015 TO 2016. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("MIGRAINES / HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MIGRAINE, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN LOWER, VULVOVAGINAL PAIN, FATIGUE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MIGRAINE, PELVIC PAIN, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DATE DISCREPANCY NOTED: (B)(6) 2014, (B)(6) 2011. MOST IF NOT ALL SYMPTOMS DECREASED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.5 KG/SQM. ULTRASOUND SCAN VAGINA - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-SEP-2019: PFS RECEIVED. REPORTER INFORMATION UPDATED. CASE BECAME INCIDENT. PREVIOUSLY REPORTED EVENT WAS UPDATED WITH NEW EVENTS: PELVIC PAIN, MIGRAINES / HEADACHES, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), LOWER ABDOMINAL PAIN, VAGINAL PAIN, FATIGUE, WEIGHT GAIN. LAB DATA, MEDICAL HISTORY ADDED. ON 11-SEP-2019: FU 2 AND 3 PROCESSED TOGETHER. MEDICAL HISTORY, CONCOMITANT DRUGS ADDED. 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.