BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANS-OBTURATOR KIT

    MDR report key: 3842828 · Received January 29, 2014

    Report

    Report Number
    2125050-2013-00605
    Event Type
    Injury
    Date Received
    January 29, 2014
    Report Date
    January 28, 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 HEALTH CARE PROFESSIONAL

    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 NOT VERIFIED, PT WAS IMPLANTED WITH THE ARIS MESH ON (B)(6) 2011. LATER PT EXPERIENCED PAIN, SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE AND INABILITY TO ENGAGE IN NECESSARY ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62260 ARIS TRANS-OBTURATOR KIT PUBORUETHRAL SUPPORT TAPE FTL COLOPLAST A/S 5195501000

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O