BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUR-FIT NATURA 2 PC POST OP DRAINABLE KIT

    MDR report key: 4324820 · Received December 5, 2014

    Report

    Report Number
    1049092-2014-00599
    Event Type
    Malfunction
    Date Received
    December 5, 2014
    Report Date
    November 5, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    FON
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE WOUND OSTOMY CARE NURSE REPORTED THAT THE TAPE COLLAR ON THE WAFER WILL NOT STICK WITHIN 24 HRS OF WEAR WHEN USED ON POST OPERATIVE UROSTOMY PATIENTS. THE TAPE COLLAR LIFTS AND MIGRATES CREATING THE WAFER TO LEAK. THE COLLAR LIFTS FROM EITHER THE TOP OR CLOSE TO THE MIDLINE INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788001 SUR-FIT NATURA 2 PC POST OP DRAINABLE KIT FON CONVATEC, INC. 416925

    Patients

    Seq Age Sex Outcome Treatment
    1