BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS

    MDR report key: 1614109 · Received February 24, 2010

    Report

    Report Number
    2125050-2010-00005
    Event Type
    Injury
    Date Received
    February 24, 2010
    Report Date
    January 26, 2010
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    FTL
    PMA / PMN Number
    K050148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT, SO NO EVALUATION WAS PERFORMED. BECAUSE THE DEVICE REMAINS IMPLANTED, COLOPLAST ACCEPTS THE PHYSICIAN'S OBSERVATIONS OF PAIN / INFECTION AS THE REASON FOR MEDICAL INTERVENTION. DEVICE NOT RETURNED; STILL IMPLANTED

    Description of Event or Problem · 1

    (B) (4). AS REPORTED TO COLOPLAST, A PATIENT EXPERIENCED SEVERE PELVIC PAIN AND CHRONIC URINARY TRACT INFECTION SINCE 2007 AFTER TOT BLADDER REPAIR SURGERY WITH THE MENTOR ARIS TRANS-OBTURATOR TAPE DUE TO URINARY INCONTINENCE. PATIENT IS PRESENTLY TAKING DAILY DOSES OF ANTIBIOTICS FOR CONTROL OF THIS PROBLEM (FROM 2007 - 2009).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARIS TRANS-OBTURATOR TAPE FTL COLOPLAST MANUFACTURING US, LLC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention