BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANS-OBUTRATOR

    MDR report key: 3832053 · Received February 7, 2014

    Report

    Report Number
    2125050-2014-00188
    Event Type
    Injury
    Date Received
    February 7, 2014
    Date of Event
    May 13, 2008
    Report Date
    February 6, 2014
    Manufacturer
    COLOPLAST A/S
    Product Code
    FTL
    PMA / PMN Number
    K050148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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, PT WAS IMPLANTED WITH ARIS MESH. LATER PT EXPERIENCED LOWER URINARY TRACT DYSFUNCTION, MESH EXPOSURE AND BLADDER NECK OBSTRUCTION. A TRANSVAGINAL URETEROLYSIS AND EXCISION OF THE MESH WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79437 ARIS TRANS-OBUTRATOR PUBORUETHRAL SUPPORT TAPE FTL COLOPLAST A/S 5195501000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other