BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUR-FIT NATURA DRAINABLE POUCH W/ INVISICLOSE

    MDR report key: 4905048 · Received July 8, 2015

    Report

    Report Number
    9618003-2015-00033
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Report Date
    June 24, 2015
    Manufacturer
    CONVATEC, INC.
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. HEIGHT: (B)(6).

    Description of Event or Problem · 1

    THE END USER REPORTED THAT THE TAIL AND TAIL CLOSURE SYSTEM OF THE POUCH RUBBED AGAINST THE INNER SIDE OF HER LEFT THIGH. AFTER THREE TO FOUR DAYS OF WEAR, THE END USER DEVELOPED A ROUGH, REDDENED PATCH OF SKIN ON THE ANTERIOR PORTION OF HER UPPER THIGH. THE PATIENT WAS REFERRED TO HER HEALTH CARE PROFESSIONAL FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443233 SUR-FIT NATURA DRAINABLE POUCH W/ INVISICLOSE POUCH, COLOSTOMY EZQ CONVATEC, INC. 413312

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR MEDICATIONS: PREDNISONE