Description of Event or Problem · 1
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: MY DOCTOR TOLD ME ESSURE HAD MIGRATED') AND INTRA-ABDOMINAL HAEMORRHAGE ('SEVERE ABDOMINAL BLEEDING (NOT MENSTRUAL)') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HEPATOMEGALY IN 2017, FATTY LIVER IN 2017, ESOPHAGOGASTRODUODENOSCOPY IN 2017, TUBAL LIGATION ON (B)(6) 2015, MENISCUS OPERATION IN (B)(6) 2014, BREAST BIOPSY IN (B)(6) 2014, BUNIONECTOMY (RIGHT FOOT) IN 2001, PNEUMONIA IN 1995, MULTIGRAVIDA, PARITY 1, ASTHMA, HYPERTENSION, OSTEOARTHRITIS KNEES, GASTRIC ULCER (NSAID RELATED), UTERINE FIBROIDS AND PERENNIAL ALLERGIC RHINITIS. THERAPY HAS INCLUDED LIFESTYLE CHANGES INCLUDING INCREASED EXERCISE. LMMUNO HISTOCHEMICAL STUDIES ACCOMPANIED WITH APPROPRIATE CONTROLS FOR HELICOBACTER PYLORI ARE NEGATIVE. DID YOU HAVE A DRINK CONTAINING ALCOHOL IN THE PAST YEAR: NO DRUGS: NEVER. ETOH USAGE: NONE ALLERGY TO SHELL FISH: HIVES, AIRWAY CLOSER. ACE INHIBITOR: COUGH: SIDE EFFECTS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR HIVES: PENICILLIN AND ULTRAM; FOR AN UNREPORTED INDICATION: MIRENA FROM 2008 TO (B)(6) 2015. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED HYPERSENSITIVITY WITH PENICILLIN AND ULTRAM. CONCURRENT CONDITIONS INCLUDED BREAST MASS (NKCH MEDICAL IMAGING, US, BREAST LIMITED RIGHT,) SINCE (B)(6) 2016, BREAST MASS (BIOPSY, MONITORING EVERY SIX MONTHS) SINCE (B)(6) 2014, ASTHMA (INHALER) SINCE 1991, COUGH (FOR TWO WEEKS PRODUCTIVE YELLOW SPUTUM), HYPERTENSION, DIZZINESS, COMMON COLD, FEVER, ASTHMA, WHEEZING, ACHING IN KNEES, OSTEOARTHRITIS, BIOPSY GASTRIC, UTERINE FIBROID, SMOKER AND MENOMETRORRHAGIA. FAMILY HISTORY INCLUDED PREMENOPAUSE, MENORRHAGIA, HEART DISEASE, UNSPECIFIED (FATHER,MATERNAL GRAND FATHER ,MATERNAL GRAND MOTHER) AND HEART MURMUR (BROTHER 1: ALIVE). CONCOMITANT PRODUCTS INCLUDED AZITHROMYCIN, BUDESONIDE;FORMOTEROL FUMARATE (SYMBICORT), CETIRIZINE HYDROCHLORIDE, CORTICOSTEROID NOS, DICLOFENAC SODIUM (ANTI-INFLAMMATORY), DOXYCYCLINE HYCLATE, FLUCONAZOLE, FLUTICASONE PROPIONATE;SALMETEROL XINAFOATE (ADVAIR), HYDROCODONE BITARTRATE;PARACETAMOL (HYDROCODONE/ACETAMINOPHEN), IBUPROFEN, IOHEXOL (OMNIPAQUE), METRONIDAZOLE, MONTELUKAST, OMEPRAZOLE, PREDNISONE, RANITIDINE, SALBUTAMOL (ALBUTEROL), SALBUTAMOL SULFATE (PROAIR HFA), SALBUTAMOL SULFATE (VENTOLIN HFA) AND VALSARTAN. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE/FATIGUE,"), 2 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2015, THE PATIENT EXPERIENCED HEADACHE ("REGULAR HEADACHE"), DYSPAREUNIA ("PAIN DURING SEX/DYSPAREUNIA") AND MIGRAINE ("MIGRAINES / HEADACHES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND ABDOMINAL PAIN LOWER. IN (B)(6) 2015, THE PATIENT EXPERIENCED VULVOVAGINAL RASH ("RASHESH OR SKIN CONDITIONS TYPE: VAGINAL AREA"). IN (B)(6) 2016, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL CRAMPING/DYSMENORRHEA (CRAMPING),"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MENSTRUATION IRREGULAR ("HORMONAL CHANGES DESCRIBE: IRREGULAR PERIOD,"). IN 2016, THE PATIENT EXPERIENCED MENORRHAGIA ("PERSISTENT INCREASED MENSTRUAL FLOW / CLOTTING/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INTRA-ABDOMINAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN UPPER ("UPPER ABDOMINAL PAIN"), BACK PAIN ("LOWER BACK PAIN"), PRURITUS ("ITCHING"), HYPOAESTHESIA ("NUMBNESS IN HANDS AND FEET"), PARAESTHESIA ("TINGLING IN HANDS AND FEET"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND VAGINAL INFECTION ("VAGINAL INFECTION") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("FIBROIDS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE WAS REMOVED VIA HYSTERECTOMY FULL WITH BILATERAL SALPINGECTOMY.). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, INTRA-ABDOMINAL HAEMORRHAGE, BACK PAIN, HEADACHE, PRURITUS, HYPOAESTHESIA, PARAESTHESIA, DYSMENORRHOEA, MENORRHAGIA, VAGINAL DISCHARGE, VAGINAL INFECTION, UTERINE LEIOMYOMA, ALOPECIA, MENSTRUATION IRREGULAR AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN UPPER, DYSPAREUNIA, FATIGUE, VULVOVAGINAL RASH, MIGRAINE AND WEIGHT INCREASED WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN UPPER, ALOPECIA, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, HYPOAESTHESIA, INTRA-ABDOMINAL HAEMORRHAGE, MENORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, PARAESTHESIA, PRURITUS, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VULVOVAGINAL RASH AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS INSERTED IN OR ABOUT (B)(6) 2015 OR 2016. SHE'S BEEN TAKING OMEPRAWLE 20-40 MG DAILY. EGD FOLLOW-UP PLANNED IN 2 MONTHS. TRAILING COILS IN UTERUS: 4.5 LEFT SIDE, 2.5 RIGHT SIDE DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.6 KG/SQM. ULTRASOUND SCAN VAGINA - IN (B)(6) 2015: RESULTS: TOTAL BILATERAL OCCLUSION.. BREAST ULTRASOUND WAS PERFORMED OF THE RIGHT BREAST, WITH EVALUATION FOCUSING ONLY ON SPECIFIC AREAS OF CONCERN. CURRENT WEIGHT (B)(6). APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT (B)(6). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, ABDOMINAL PAIN LOWER, MENORRHAGIA, AND UTERINE LEIOMYOMA. QUALITY-SAFETY EVALUATION OF PTC: PTC GLOBAL NUMBER : (B)(4). SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LIT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-APR-2021: MR RECEIVED. REPORTER'S INFORMATION ADDED. RCC ADDED.FU RECEIVED. NO NEW SIGNIFICANT CHANGE MADE IN MEDICAL CONTEXT OF CASE. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.