BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANS-OBTURATOR

    MDR report key: 3840644 · Received January 30, 2014

    Report

    Report Number
    2125050-2014-00121
    Event Type
    Injury
    Date Received
    January 30, 2014
    Date of Event
    September 16, 2010
    Report Date
    January 30, 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, PATIENT WAS IMPLANTED WITH ARIS MESH. LATER THE PATIENT EXPERIENCED STRESS URINARY INCONTINENCE, NOCTURNAL ENURESIS, URGE INCONTINENCE, ATROPHIC VAGINITIS, CYSTOCELE AND RECTOCELE, POSSIBLE TAPE SLIPPING AND DYSPAREUNIA. AN EXCISION OF THE MESH AND CYTOSCOPY WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65304 ARIS TRANS-OBTURATOR POLYMERIC SURGICAL MESH FTL COLOPLAST A/S 5195511400 2079397

    Patients

    Seq Age Sex Outcome Treatment
    1 Other