BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANSOBTURATOR KIT

    MDR report key: 12450640 · Received September 9, 2021

    Report

    Report Number
    2125050-2021-01285
    Event Type
    Injury
    Date Received
    September 9, 2021
    Report Date
    December 15, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTN
    PMA / PMN Number
    K050148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS PREVIOUSLY REPORTED VIA ALTERNATIVE SUMMARY REPORT ON 19DEC2018, EXEMPTION NUMBER E2014015 AND FOLLOW-UP REPORT TO 2125050-2021-01285. ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT'S LEGAL REPRESENTATIVE STATED EXTREME PAIN, DISCOMFORT, URINARY PROBLEMS, DYSPAREUNIA AND UNDERWENT MULTIPLE CORRECTIVE SURGERIES TO REMOVE OR REVISE PART OF THE PELVIC MESH DEVICE. ARIS WAS IMPLANTED ON (B)(6) 2010. CORRECTIVE ACTION: MANAGEMENT ROUTINELY REVIEWS EVENTS SUCH AS THIS AND MONITORS COMPLAINT LEVELS. ADDITIONALLY, EVENTS OF THIS TYPE RELATING TO THE REPORTED COMPLAINTS ARE CAPTURED IN THE PRODUCT RISK DOCUMENTATION. BASED ON THIS, AND BECAUSE THE DEVICE IS NOT AVAILABLE FOR EVALUATION, NO FURTHER CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FURTHER REPORTED THAT ON THE FOLLOWING DATES THE PATIENT HAD EXPERIENCED OR WAS EXPERIENCING THE FOLLOWING: (B)(6) 2017: MESH MATERIAL 5 CM FROM INTROITUS ALONG THE POSTERIOR VAGINAL WALL PROTRUDING INTO THE VAGINAL LUMEN SLIGHTLY ECCENTRIC TO THE LEFT SIDE. (B)(6) 2017: CT CYSTOGRAM SHOWED TINY HYPERDENSITY POSTERIOR TO BLADDER. DYSPAREUNIA. (B)(6) 2017: DYSURIA, (B)(6) 2018: SUI, (B)(6) 2019: VAGINAL DISCHARGE, (B)(6) 2021: STRESS INCONTINENCE, URINARY RETENTION, (B)(6) 2021: MILD SCARRING AT ANTERIOR VAGINAL WALL, (B)(6) 2021: MILD VAGINAL DISCHARGE, (B)(6) 2021: URINARY INCONTINENCE, VAGINAL DISCOMFORT.

    Description of Event or Problem · 0

    AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, ADDITIONAL INFORMATION RECEIVED ON 09/15/2021. (B)(6) 2017: MESH EXPOSURE, DYSPAREUNIA, VAGINAL DISCHARGE, VAGINAL BLEEDING. (B)(6) 2017: MESH EXTRUSION, BLADDER DEFECT, VAGINAL PROLAPSE, VAGINAL BLEEDING, VAGINAL PAIN. (B)(6) 2017 - (B)(6) 2018: INCONTINENCE. (B)(6) 2018: VESICOVAGINAL FISTULA (VVF). HARVEST OF FASCIA LATA, PLACEMENT OF FASCIAL SLING, TRANSVAGINAL VESICOVAGINAL FISTULA REPAIR X2 (BILATERAL), PLACEMENT OF ACELL BIOLOGICAL GRAFT, ANTERIOR VAGINAL WALL RECONSTRUCTION, CYSTOSCOPY W/URETERAL CATHETERIZATION (BILATERAL) [NO OPERATIVE REPORT]. (B)(6) 2018: PERSISTENT LEAKING USING 1 PAD EVERY 4-6 HOURS. (B)(6) 2018: PERSISTENT LEAKING, ASSUMED CONTINUED VESICOVAGINAL FISTULA (VVF). (B)(6) 2018: VVF AT THE MID-ANTERIOR VAGINAL WALL (LEFT LATERAL SULCI), VVF AT THE DISTAL ANTERIOR VAGINAL WALL (AT THE MIDLINE), VVF AT THE MID-ANTERIOR VAGINAL WALL (RIGHT LATERAL SULCI), ALTHOUGH THIS WAS HARD TO DISCERN, DID NOT SEE ANY APICAL FISTULA (CERVIX IN PLACE). (B)(6) 2018: COMPLICATION OF IMPLANTED VAGINAL MESH, SEQUELA, MIXED STRESS AND URGE URINARY INCONTINENCE, VAGINAL ATROPHY. (B)(6) 2018: 3-4 MM FISTULOUS TRACTS (2 OF THEM) DIRECTLY AT THE POSTERIOR BLADDER NECK. (B)(6) 2019: ROBOTIC ASSISTED LAPAROSCOPIC VESICOVAGINAL FISTULA REPAIR, PLACEMENT OF ACELL BIOLOGICAL GRAFT, PLACEMENT OF SUPRAPUBIC TUBE, CYSTOSCOPY WITH BILATERAL URETERAL STENT PLACEMENT [NO OPERATIVE REPORT]. (B)(6) 2019: UTI, YEAST INFECTION. (B)(6) 2019: SEQUELA, MIXED STRESS AND URGE URINARY INCONTINENCE. (B)(6) 2019: RESOLUTION OF VESICOVAGINAL FISTULA, LEAKING ONLY A SMALL AMOUNT UPON STANDING. (B)(6) 2020: PIN POINT FISTULA AT 6 O¿CLOCK POSTERIOR BLADDER NECK. (B)(6) 2021: TRANSVAGINAL PARTIAL CYSTECTOMY, CREATION OF MARTIUS FLAP, PLACEMENT OF ACELL BIOLOGICAL GRAFT, AND CYSTOSCOPY WITH SUPRAPUBIC TUBE PLACEMENT [NO OPERATIVE REPORT]. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    LOT NUMBER: AK060032. THIS EVENT WAS PREVIOUSLY REPORTED VIA ALTERNATIVE SUMMARY REPORT ON 19DEC2018, EXEMPTION NUMBER E2014015. THIS REPORT IS INTENDED TO BE A FOLLOW-UP REPORT TO SUBMIT ADDITIONAL INFORMATION THAT HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FURTHER REPORTED THAT IN (B)(6) 2017 THE PATIENT HAD EXPERIENCED OR WAS EXPERIENCING MESH EXTRUSION AT THE VAGINAL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347522 ARIS TRANSOBTURATOR KIT SURGICAL MESH OTN COLOPLAST A/S 5195501400

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention