BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANS-OBUTRATOR

    MDR report key: 3832058 · Received February 7, 2014

    Report

    Report Number
    2125050-2014-00184
    Event Type
    Injury
    Date Received
    February 7, 2014
    Date of Event
    May 21, 2010
    Report Date
    February 6, 2014
    Manufacturer
    COLOPLAST A/S
    Product Code
    FTL
    PMA / PMN Number
    K050148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFO 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 URINARY TRACT INFECTION, LEAKAGE, EROSION OF THE URETHRA, LITTLE PIECES OF MESH WITH SOME CRYSTALS THAT ARE SOME OLD CALCIFICATIONS AND A STONE ON THE RIGHT SULCUS OF THE URETHRA. A MESH REVISION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79190 ARIS TRANS-OBUTRATOR PUBORUETHRAL SUPPORT TAPE FTL COLOPLAST A/S 5195501000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other