BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUR-FIT NATURA POUCH

    MDR report key: 4192856 · Received October 20, 2014

    Report

    Report Number
    MW5038708
    Event Type
    Other
    Date Received
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    CONVATEC
    Product Code
    EZQ
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT'S OSTOMY POUCH HAS COME APART ON TWO OCCASIONS AT THE RING. PT WANTS THE MFR TO PUT A WARNING ON THE PACKAGE FOR USERS TO TUG ON THE POUCH BEFORE USING IT. PT WILL LIKE TO KNOW THE FAILURE RATE OF THESE POUCHES. ALSO WANTS TO KNOW WHAT STEPS THE MANUFACTURER IS TAKING TO AMEND THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666779 SUR-FIT NATURA POUCH SUR-FIT EZQ CONVATEC H01019

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR