Description of Event or Problem · 1
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION"), UTERINE PERFORATION ("PERFORATION/SUSPECTED PERFORATED UTERUS BY ESSURE"), EMBEDDED DEVICE ("THE RIGHT ESSURE DEVICE WAS DEEPLY EMBEDDED IN THE UTERINE CORNUAL MYOMETRIUM."), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY TEST POSITIVE") AND ABORTION SPONTANEOUS ("MISCARRIED") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR TUBAL LIGATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED CHILLS, HEADACHE, SINUS PAIN, EARACHE, SNEEZING, SINUSITIS, COUGH AND HYPOTHYROIDISM. CONCURRENT CONDITIONS INCLUDED TONSILLITIS, ESOPHAGITIS, ALLERGIC RHINITIS, FATIGUE, ASTHMA, STREPTOCOCCAL PHARYNGITIS, FEVER, UPPER RESPIRATORY INFECTION, ACUTE BRONCHITIS, VOMITING, BACK PAIN, NAUSEA, PAIN IN EXTREMITY, ABDOMINAL PAIN, ANXIETY, DYSMENORRHEA, GERD, RENAL DISEASE AND RENAL COLIC. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER ("MASSIVE PAIN LOWER LEFT SIDE OF ABDOMEN") WITH AGGRESSION, HEADACHE ("HEADACHES") WITH MOOD ALTERED, OVARIAN CYST ("GETTING CYSTS ON HER OVARIES"), DYSPAREUNIA ("INTERCOURSE HURT/PAIN WITH SEX"), PROCEDURAL PAIN ("GETTING A HYSTEROSALPINGOGRAM WAS PAINFUL TOO"), PELVIC PAIN ("PAIN ") AND CERVICAL DYSPLASIA AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH MENSTRUATION DELAYED. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, UTERINE PERFORATION, EMBEDDED DEVICE, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, ABDOMINAL PAIN LOWER, HEADACHE, OVARIAN CYST, DYSPAREUNIA, PROCEDURAL PAIN, PELVIC PAIN AND CERVICAL DYSPLASIA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN LOWER AND HEADACHE WITH ESSURE. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, CERVICAL DYSPLASIA, DEVICE DISLOCATION, DYSPAREUNIA, EMBEDDED DEVICE, OVARIAN CYST, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, PROCEDURAL PAIN AND UTERINE PERFORATION TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING: DYSPLASIA OF CERVIX. QUALITY-SAFETY EVALUATION OF PTC: FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. 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. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A REQUEST FOR CONFIRMATION OF QUALITY. THE REPORTED ADVERSE EVENTS ARE NOT INDICATIVE OF A QUALITY DEFECT PER SE AND WERE REPORTED WITH AN OCCURRENCE OVER A PERIOD OF 4,5 YEARS. NO BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION NO BATCH SIGNAL CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-DEC-2018: PFS AND MEDICAL RECORD RECEIVED. REPORTER'S INFORMATION WAS ADDED. ADDED EVENT PAIN, MIGRATION, PERFORATION/ ( ADDED FROM MEDICAL RECORD SUSPECTED PERFORATED UTERUS BY ESSURE), CERVICAL DYSPLASIA. EVENT ADDED FROM REMOVAL DETAILS THE RIGHT ESSURE DEVICE WAS DEEPLY EMBEDDED IN THE UTERINE CORNEAL MYOMETRIUM. HISTORICAL CONDITION, CONCOMITANT CONDITION WERE ADDED. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.