Description of Event or Problem · 1
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DIABETES MELLITUS, HYPERTENSION, IODINE ALLERGY, DEPRESSION, FATIGUE, UTERINE BLEEDING AND PELVIC PAIN. IN 2003, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("BLEEDING"), ALLERGY TO METALS ("NICKEL SENSITIVITY"), ALOPECIA ("HAIR LOSS"), DEPRESSION ("DEPRESSION"), ANAEMIA ("ANEMIA"), MENORRHAGIA ("MENORRHAGIA") AND PERIHEPATITIS ("FITZ-HUGH CURTIS SYNDROME (PERIHEPATITIS)"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY). AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ALLERGY TO METALS, ALOPECIA, DEPRESSION, ANAEMIA, MENORRHAGIA AND PERIHEPATITIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALLERGY TO METALS, ALOPECIA, ANAEMIA, DEPRESSION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND PERIHEPATITIS TO BE RELATED TO ESSURE (ESS205). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-JUL-2020: MR RECEIVED: CASE WAS UPGRADED TO INCIDENT. ESSURE REMOVAL DATE , EVENT MENORRHAGIA , PER HEPATITIS , MENORRHAGIA AND ANEMIA ADDED, MEDICAL HISTORY ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.