BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASILK FLAT SQUARE MESH

    MDR report key: 3892264 · Received June 24, 2014

    Report

    Report Number
    2125050-2014-00378
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    June 1, 2010
    Report Date
    June 24, 2014
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTO
    PMA / PMN Number
    K122968
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT WAS IMPLANTED WITH NOVASILK MESH. LATER THE PATIENT EXPERIENCED MUSCLE PULLING OVER RIGHT HIP AND BUTTOCK, URINARY INCONTINENCE, URINARY TRACT INFECTIONS AND PERSISTENT URINARY FREQUENCY. THE PATIENT WAS PRESCRIBED VESICARE, ANTIBIOTICS FOR FREQUENT URINARY TRACT INFECTIONS, CIPRO, MACRODANTIN AND TOVIAZ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369002 NOVASILK FLAT SQUARE MESH OTO OTO COLOPLAST A/S 5196101000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other