Description of Event or Problem · 1
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY (STILLBIRTH OR MISCARRIAGE)'), GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)'), ABORTION SPONTANEOUS ('PREGNANCY (STILLBIRTH OR MISCARRIAGE)') AND AUTOIMMUNE DISORDER ('AUTOIMMUNE DISORDER - TYPE OF DISORDER:') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863568) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY NO". THE PATIENT'S MEDICAL HISTORY INCLUDED MISCARRIAGE IN 2010, MULTIGRAVIDA, PARITY 5 (DATE OF LIVE BIRTHS: (B)(6) 2003, (B)(6) 2004, (B)(6) 2007, (B)(6) 2009, (B)(6) 2011.), ANEMIC AND ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE. CURRENT WEIGHT (B)(6). CONCURRENT CONDITIONS INCLUDED UNILATERAL LEG PAIN. CONCOMITANT PRODUCTS INCLUDED IRON FOR ANEMIC. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2011, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2013, THE PATIENT EXPERIENCED BACK PAIN ("OTHER INJURY (IES) OR COMPLICATION(S) PLEASE DESCRIBE: LOWER BACK / RIGHT SIDE LOWER BACK PAIN") AND ARTHRALGIA ("OTHER INJURY (IES) OR COMPLICATION(S) - PLEASE DESCRIBE: HIP PAIN / KNEE PAIN"). ON (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) LOSS") AND EXPERIENCED IMMUNODEFICIENCY ("OTHER INJURY (IES) OR COMPLICATION(S) PLEASE DESCRIBE: COMPROMISED IMMUNE SYSTEM/LOWER BACK, HIP & COMPROMISED IMMUNE SYSTEM"). ON (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2014, THE PATIENT EXPERIENCED HYPERHIDROSIS ("SWEATING/ HOT AND COLD SWEATING"), MOOD ALTERED ("HORMONAL CHANGES/HORMONAL CHANGES DESCRIBE: MOOD,"), EMOTIONAL DISORDER ("EMOTIONAL DISCHARGE") AND MENSTRUATION IRREGULAR ("IRREGULAR MENSES"). ON (B)(6) 2015, THE PATIENT EXPERIENCED BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), ALLERGY TO METALS ("NICKEL ALLERGY") AND PRURITUS ("ITCHING"). ON (B)(6) 2015, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DERMATITIS ACNEIFORM ("ALLERGIC OR HYPERSENSITIVITY REACTION-BUMPS/PIMPLE LIKE BUMPS ON BOTH ARMS AND LEGS"), RASH ("RASHES OR SKIN CONDITIONS-PAINFUL RASH"), ERYTHEMA ("RASHES OR SKIN CONDITIONS-REDNESS") AND PERIPHERAL SWELLING ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: SWOLLING/SWELLING OF FEET AND OTHER AREAS, AND LIMBS"). ON (B)(6) 2016, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2016, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS-DEPRESSION,") AND ANXIETY ("ANXIETY"). ON (B)(6) 2016, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES"), NAUSEA ("NAUSEA") AND HEADACHE ("HEADACHES"). ON (B)(6) 2016, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). ON (B)(6) 2017, THE PATIENT EXPERIENCED EYE DISORDER ("VISION/EYE PROBLEMS- TYPE:") AND VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS- TYPE:"). IN (B)(6) 2017, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND EXPERIENCED AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), INFECTION ("INFECTION (OTHER) DESCRIBE:"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL)"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL)"), MOOD SWINGS ("HORMONAL CHANGES/HORMONAL CHANGES DESCRIBE: MOOD,"), BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BREAST TENDERNESS ("BREAST TENDERNESS") AND PAIN IN EXTREMITY ("FOOT PAIN"). THE PATIENT WAS TREATED WITH ANTIBIOTICS AND SERTRALINE HYDROCHLORIDE (ZOLOFT). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, ABORTION SPONTANEOUS, AUTOIMMUNE DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, BACK PAIN, DERMATITIS ACNEIFORM, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, TOOTH DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, ALOPECIA, HYPERHIDROSIS, INFECTION, MIGRAINE, NAUSEA, ALLERGY TO METALS, DEPRESSION, RASH, ERYTHEMA, VAGINAL DISCHARGE, WEIGHT DECREASED, ARTHRALGIA, IMMUNODEFICIENCY, EYE DISORDER, VISUAL IMPAIRMENT, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, MOOD SWINGS, PERIPHERAL SWELLING, BACTERIAL VAGINOSIS, MOOD ALTERED, ANXIETY, HEADACHE, ABDOMINAL PAIN, BREAST TENDERNESS, PAIN IN EXTREMITY, EMOTIONAL DISORDER, MENSTRUATION IRREGULAR AND PRURITUS OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 8, PARA 5. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, ALLERGY TO METALS, ALOPECIA, ANXIETY, ARTHRALGIA, AUTOIMMUNE DISORDER, BACK PAIN, BACTERIAL VAGINOSIS, BLADDER DISORDER, BREAST TENDERNESS, CYSTITIS, DEPRESSION, DERMATITIS ACNEIFORM, DYSMENORRHOEA, DYSPAREUNIA, EMOTIONAL DISORDER, ERYTHEMA, EYE DISORDER, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HYPERHIDROSIS, IMMUNODEFICIENCY, INFECTION, MENORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, MOOD ALTERED, MOOD SWINGS, NAUSEA, PAIN IN EXTREMITY, PERIPHERAL SWELLING, PREGNANCY WITH CONTRACEPTIVE DEVICE, PRURITUS, RASH, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISUAL IMPAIRMENT AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF EXPERIENCED ANOTHER PREGNANCY THAT WAS CAPTURED IN CASE (B)(4). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.3 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-DEC-2019: PFS RECEIVED- NEW EVENTS SWEATING/ HOT AND COLD SWEATING, SWELLING OF FEET, BACTERIAL VAGINOSIS, MOOD SWINGS, HEADACHES, FOOT PAIN, BREAST TENDERNESS, ABDOMINAL PAIN, EMOTIONAL DISCHARGE, IRREGULAR MENSES, ITCHING WERE ADDED. EVENT HORMONAL CHANGES UPDATED TO MOOD CHANGES. HYPERSENSITIVITY REACTION UPDATED TO PIMPLE-LIKE BUMPS ON SKIN. EVENT SKIN DISORDER UPDATED TO REDNESS. PSYCHIATRIC PROBLEMS UPDATED TO DEPRESSION. TREATMENT DRUG WERE 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.