ARIS TRANSOBTURATOR SYSTEM

Description of Event or Problem

AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT HAD AN ARIS DEVICE IMPLANTED IN (B)(6) 2019. REPORTEDLY, THE PATIENT EXPERIENCED NAUSEA, DIZZINESS, WEAKNESS, RECURRENT SUI RELATED TO SEVERE BRONCHITIS AND COUGHING AFTER SLING PLACEMENT AND DYSPAREUNIA. CYSTOSCOPY PERFORMED IN OFFICE WITH NO EVIDENCE OF MESH EROSION. THE PATIENT EXPERIENCED DYSURIA, URINARY TRACT INFECTION, URINARY FREQUENCY, URGENCY, HEMATURIA, PELVIC PAIN, ABNORMAL VAGINAL DISCHARGE, FRIABLE VAGINAL TISSUE, MESH EROSION AND PAIN WITH URINATION. A MESH REVISION AND CYSTOSCOPY WERE PERFORMED UNDER GENERAL ANESTHESIA IN (B)(6) 2024. POST EXCISION, PATIENT REPORTEDLY EXPERIENCED URGENCY, FREQUENCY, FEELING OF INCOMPLETE BLADDER EMPTYING, URINARY TRACT INFECTION REQUIRING MEDICATION, PELVIC AND PERINEAL PAIN, STRESS URINARY INCONTINENCE, DYSPAREUNIA, STAGE 2 CYSTOCELE, STAGE 2 RECTOCELE, AND STAGE 2 APICAL PROLAPSE. BIMANUAL EXAM REVEALED HYPERMOBILE URETHRA; TENDERNESS BILATERALLY AND A HARD OBJECT PALPATED ON THE LEFT DESCRIBED AS POSSIBLY AN ANCHOR VS. CALCIFIED CYST.

Additional Manufacturer Narrative

THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE. NO TRENDS WERE NOTED FOR COMPLAINTS AND THERE WERE NO NONCONFORMING REPORTS OR CAPAS THAT WERE CONFIRMED IN VEEVA TO BE ASSOCIATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, COLOPLAST CANNOT COMMENT ON THE CONDITION OF THE DEVICE. SHOULD ADDITIONAL INFORMATION PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED.