BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANS OBTURATOR KIT

    MDR report key: 2830081 · Received November 13, 2012

    Report

    Report Number
    2125050-2012-00107
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    May 31, 2012
    Report Date
    November 13, 2012
    Manufacturer
    COLOPLAST A/S
    Product Code
    FTL
    PMA / PMN Number
    K050148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THIS REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT IMPLANTED WITH ARIS MESH ON (B)(6) 2011. LATER THE PATIENT EXPERIENCED MESH EROSION, PAIN AND POSSIBLE MESH PERFORATION. ON (B)(6) 2012, PATIENT UNDERWENT SURGERY TO REMOVE ARIS MESH, PATIENT CONTINUES TO EXPERIENCE PAIN,URINARY INCONTINENCE AND LOSS OF ABILITY TO PERFORM SEXUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARIS TRANS OBTURATOR KIT PUBORUETHRAL SUPPORT TAPE FTL COLOPLAST A/S 5195102400 AK080047

    Patients

    Seq Age Sex Outcome Treatment
    1 Other