Description of Event or Problem · 1
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("PROLONGED MENSES") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE INSERTED FOR PERMANENT CONTRACEPTIVE TUBAL IMPLANT. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), MIGRAINE ("MIGRAINES"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEM OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEM OR CHANGES"), PELVIC PAIN ("PAIN") AND HEADACHE ("HEADACHES"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN") AND BACK PAIN ("SEVERE BACK PAIN"). THE PATIENT WAS TREATED WITH CO-TRIMOXAZOLE (BACTRIM), PHENAZOPYRIDINE HYDROCHLORIDE (PYRIDIUM), CILEST (SPRINTEC), SURGERY (ENDOMETRIAL ABLATION) AND SURGERY (ENDOMETRIAL ABLATION). AT THE TIME OF THE REPORT, THE VAGINAL HAEMORRHAGE, MENORRHAGIA, GENITAL HAEMORRHAGE, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, BACK PAIN, DYSPAREUNIA, MIGRAINE, BLADDER DISORDER, URINARY TRACT DISORDER, PELVIC PAIN AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BACK PAIN, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. 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. THE REPORTED MEDICAL EVENTS ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. AS NO BATCH NUMBER WAS REPORTED A TECHNICAL BATCH INVESTIGATION AND A REVIEW OF SIMILAR AE CASE REPORTS IS NOT POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER INVESTIGATION THEREFORE THE COMPLAINT COULD NOT BE EVALUATED IN GREATER DETAIL. THE TECHNICAL ASSESSMENT CONCLUDED A QUALITY DEFECT WAS NOT CONFIRMED BUT CONSIDERED PLAUSIBLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENT CANNOT BE TOTALLY EXCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-MAR-2018: CASE IS NOW INCIDENT. PFS AND MEDICAL RECORD RECEIVED. EVENTS WERE ADDED FROM PFS: ABNORMAL VAGINAL BLEEIDNG, BLADDER OR URINARY PROBLEMS OR CHANGES, URINARY PROBLEMS OR CHANGES, PAIN. LAB DATA WAS ADDED. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, (B)(4) TO BAYER PHARMA (B)(4), AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.