BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANSOBTURATOR KIT

    MDR report key: 11644986 · Received April 9, 2021

    Report

    Report Number
    2125050-2021-00313
    Event Type
    Injury
    Date Received
    April 9, 2021
    Report Date
    April 9, 2021
    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 · 1

    THE LOT # WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED. 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. COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. LOT NUMBER: 170654.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT EXPERIENCED STRESS URINARY INCONTINENCE AND SLING EROSION. THE SLING WAS REMOVED AND REPLACED WITH ANOTHER MANUFACTURER¿S PRODUCT UNDER GENERAL ANESTHESIA. FINDINGS NOTED INCLUDED: ¿SLING APPEARED TO BE NOT OF THE MESH ORIGIN. SIGNIFICANT INFLAMMATORY CHANGES OF THE PERIURETHRAL TISSUE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540348 ARIS TRANSOBTURATOR KIT SURGICAL MESH OTN COLOPLAST A/S 5195512400 05708932442961

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention