BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANS-OBTURATOR

    MDR report key: 3842729 · Received January 24, 2014

    Report

    Report Number
    2125050-2014-00088
    Event Type
    Injury
    Date Received
    January 24, 2014
    Date of Event
    September 11, 2012
    Report Date
    January 23, 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 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 THE PT EXPERIENCED MESH EROSION, GROSS HEMATURIA, PAIN, NOCTURIA, DYSPAREUNIA, BACTERIAL VAGINAL INFECTION, EXPOSURE AND LOSS OF CONSORTIUM. PARTIAL REMOVAL OF THE MESH AND A CYSTOURETHROSCOPY WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55786 ARIS TRANS-OBTURATOR POLYMERIC SURGICAL MESH FTL COLOPLAST A/S 5195501000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other