SUPRIS RETROPUBIC KIT

Additional Manufacturer Narrative

AS NO LOT # WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS COULD NOT BE COMPLETED. 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.

Description of Event or Problem

AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT HAD A SUPRIS IMPLANTED IN (B)(6) 2019. REPORTEDLY, THE PATIENT EXPERIENCED STRESS URINARY INCONTINENCE, DISCOMFORT WITH STRAINING, NOCTURIA, LOWER ABDOMINAL PAIN, URINARY FREQUENCY, DYSURIA, URGENCY, FEVER, FATIGUE, DOUBLE VOIDING, BLADDER SPASM, RECURRENT URINARY TRACT INFECTIONS, WORSENING DYSPAREUNIA SINCE LAST PREGNANCY, PELVIC PAIN, HEMATURIA AND SUPRAPUBIC PAIN. CYSTOSCOPY, CYSTOLITHOLAPAXY AND REMOVAL OF FOREIGN BODY FROM BLADDER UNDER GENERAL ANESTHESIA PERFORMED. FINDINGS INCLUDED A FLAT 2 CM BLADDER STONE ADHERENT TO PELVIC MESH WHICH HAD ERODED INTO BLADDER. NO OBVIOUS BLADDER TUMOR BUT IRRITATION OF THE MUCOSA ALONGSIDE THE STONE. PATIENT REPORTEDLY CONTINUED TO EXPERIENCE LEFT-SIDED PELVIC PAIN, URGENCY AND LOW-GRADE FEVER. FURTHER CYSTOSCOPY: CENTRAL LEFT BLADDER WALL HAS A SMALL PIECE OF MESH WITH MOUNDED INFLAMED MUCOSA AROUND IT. THERE WAS SOME SUPERFICIAL CALCIFICATION OVERLYING THE MESH SEEN. PLAN FOR SLING REMOVAL BUT NO CONFIRMATION THIS HAS YET BEEN PERFORMED.