BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2 PC DRAINABLE INVISICLOSE

    MDR report key: 3848650 · Received May 21, 2014

    Report

    Report Number
    9618003-2014-00048
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EZQ
    PMA / PMN Number
    K833625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A SERIOUS INJURY. THE END USER STATED "IT GOT ON MY SKIN AND IT TOOK A MONTH TO CLEAR UP." THE END USER ALSO STATED HE WENT TO THE DERMATOLOGIST AND WAS PRESCRIBED AN ANTI-FUNGAL POWDER AND AQUAPHOR OVER THE COUNTER OINTMENT. A LOT NUMBER FOR THE PRODUCT WAS NOT AVAILABLE. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. REPORTED TO THE FDA ON (B)(4) 2014. NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    AN END USER STATED DUE TO THE LEAKAGE OF STOOL AT THE TAIL CLOSURE. THE END USER ALSO STATED HE WENT TO THE DERMATOLOGIST WITH A SEVERE FUNGAL INFECTION IN HIS CROTCH DUE TO LEAKAGE WITHOUT A PROTECTIVE DIAPER COLLECTING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302134 SUR-FIT NATURA 2 PC DRAINABLE INVISICLOSE POUCH, COLOSTOMY, 78EZQ EZQ CONVATEC INC. 413335 CNO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention