Description of Event or Problem · 1
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A (B)(6) YEAR OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922606) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING(MENORRHAGIA)") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"), 9 MONTHS 12 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), HIRSUTISM ("HORMONAL CHANGES DESCRIBE: HAIR GROWTH") AND POLYCYSTIC OVARIES ("OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: POS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, VULVOVAGINAL PAIN, HIRSUTISM, VAGINAL HAEMORRHAGE, MENORRHAGIA, FATIGUE, WEIGHT INCREASED AND POLYCYSTIC OVARIES OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, FATIGUE, GENITAL HAEMORRHAGE, HIRSUTISM, MENORRHAGIA, PELVIC PAIN, POLYCYSTIC OVARIES, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE OF INSERTION (B)(6) 2011 AND (B)(6) 2012. CURRENT WEIGHT (B)(6). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.5 KG/SQM. LOT NUMBER: 922606, MANUFACTURE DATE: 2011-11, EXPIRATION DATE: 2014-11. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-JUL-2020: PIF RECEIVED: CASE WAS UPGRADED TO INCIDENT. ESSURE INSERTION DATE UPDATED AND REMOVAL DATE ADDED. NEW REPORTER 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.