BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANS-OBTURATOR

    MDR report key: 3842840 · Received August 21, 2013

    Report

    Report Number
    2125050-2013-00171
    Event Type
    Injury
    Date Received
    August 21, 2013
    Date of Event
    July 17, 2012
    Report Date
    August 21, 2013
    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 EXPERIENCED VAGINAL SPOTTING, URGE INCONTINENCE, DYSPAREUNIA AND EROSION. A VAGINAL MESH REVISION AND EXCISION WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407073 ARIS TRANS-OBTURATOR POLYMERIC, SURGICAL MESH FTL COLOPLAST A/S 5195511400 1858787

    Patients

    Seq Age Sex Outcome Treatment
    1 Other