BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANSOBTURATOR KIT

    MDR report key: 11806726 · Received May 11, 2021

    Report

    Report Number
    2125050-2021-00490
    Event Type
    Injury
    Date Received
    May 11, 2021
    Report Date
    August 11, 2022
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTN
    UDI-DI
    05708932442961
    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. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: THE PREVIOUSLY SUBMITTED H6 ANNEX A CODE A040503 "MATERIAL EROSION" WAS APPLIED IN ERROR.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 6/6/2022 REPORTED THAT THE PATIENT EXPERIENCED URINARY INCONTINENCE, A VAGINAL ULCER, ACUTE CYSTITIS, CHRONIC INFLAMMATION, FIBROSIS, AND ERODED VAGINAL TISSUE. THE PATIENT UNDERWENT AN EXCISION OF THE DEVICE UNDER GENERAL ANESTHESIA ON (B)(6) 2019.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FURTHER REPORTED THAT VAGINAL TISSUE SHOWED INFLAMMATION AND FIBROSIS WITH A FRAGMENT OF FOREIGN MATERIAL CONSISTENT WITH MESH. THE PATIENT EXPERIENCED DYSURIA, FEVER, CHILLS, NAUSEA, AND WAS DIAGNOSED WITH A URINARY TRACT INFECTION. THE PATIENT ALSO EXPERIENCED RETENTION, LEVATOR MYALGIA, URETHRAL HYPERMOBILITY, AND MICROSCOPIC HEMATURIA. PHYSICAL EXAM NOTED A SMALL AREA (0.5 CENTIMETERS) OF MESH EROSION ON THE RIGHT ASPECT OF THE ANTERIOR VAGINAL WALL. COMPUTED TOMOGRAPHY (CT) UROGRAM WAS NEGATIVE FOR ANY OBSTRUCTIVE UROPATHY OR FILLING DEFECTS. THE PATIENT WAS STARTED ON DETROL AND CIPRO. ON 27JAN2020, THE PATIENT¿S URINARY RETENTION, DYSPAREUNIA, STRESS URINARY INCONTINENCE, AND VAGINAL BLEEDING HAD RESOLVED.

    Additional Manufacturer Narrative · 1

    THE LOT # WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED. COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.¿.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, IT WAS REPORTED THAT THE PATIENT EXPERIENCED ONGOING BLEEDING, URINARY ISSUES, PROBLEMS WITH INTERCOURSE, MESH EXPOSURE IN VAGINA. PARTIAL MESH EXPLANT WITH PLACEMENT OF AN AUTOLOGOUS PUBOFASCIAL SLING. CURRENTLY, PLAINTIFF CONTINUES TO EXPERIENCE PROBLEMS, GROIN PAIN, PELVIC PAIN, VAGINAL PAIN, PAINFUL INTERCOURSE AND URINARY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701337 ARIS TRANSOBTURATOR KIT SURGICAL MESH OTN COLOPLAST A/S 5195512400 05708932442961

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention