BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANS-OBTURATOR

    MDR report key: 3840750 · Received January 30, 2014

    Report

    Report Number
    2125050-2014-00141
    Event Type
    Injury
    Date Received
    January 30, 2014
    Date of Event
    September 12, 2012
    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
    OTHER

    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 VERIFIED, PT WAS IMPLANTED WITH ARIS MESH. LATER THE PT EXPERIENCED INCOMPLETE EMPTYING AND STRAINING TO VOID, DYSPAREUNIA, BLADDER OUTLET OBSTRUCTION AND MESH EXTRUSION. AN EXCISION OF THE MESH, RIGID CYSTOSCOPY, POSTERIOR COLPORRHAPHY AND PERINEAL BODY REPAIR WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65243 ARIS TRANS-OBTURATOR POLYMERIC SURGICAL MESH, PRODUCT CODE: FTL FTL COLOPLAST A/S 5195501400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other