BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANS-OBTURATOR

    MDR report key: 3842779 · Received January 24, 2014

    Report

    Report Number
    2125050-2014-00110
    Event Type
    Injury
    Date Received
    January 24, 2014
    Date of Event
    December 31, 2009
    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 INFO CONTAINED IN THIS REPORT.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PT WAS IMPLANTED WITH ARIS AND RESTORELLE MESH PRODUCTS. LATER THE PT EXPERIENCED URINARY RETENTION, A TIGHT SLING, MESH EXPOSURE, INFECTION, PAIN, INCONTINENCE, DYSURIA AND BLEEDING. A MESH REVISION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56204 ARIS TRANS-OBTURATOR POLYMERIC SURGICAL MESH FTL COLOPLAST A/S 5195511400 2096817

    Patients

    Seq Age Sex Outcome Treatment
    1 Other