BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2 PC - DISPOSABLE CONVEX INSERT

    MDR report key: 3888033 · Received June 4, 2014

    Report

    Report Number
    1049092-2014-00168
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    February 7, 2014
    Report Date
    May 9, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    EZS
    PMA / PMN Number
    K811239
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. AN ALTERNATE PRODUCT SAMPLE HAS BEEN SENT, AND THE USE OF OSTOMY APPLIANCE BELT WAS DISCUSSED WITH END-USER. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. SHOULD ADD'L INFO BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4) CONVATEX WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE END-USER WAS HOSPITALIZED ON (B)(6) 2014 FOR A DURATION OF THREE (3) WEEKS AND RECEIVING INTRAVENOUS ANTIBIOTICS VIA PIC LINE FOR A STOMACH INFECTION RELATED TO REPEATED USE OF THE SAME CONVEX INSERT. THE PT WAS INSTRUCTED, BY THE INFECTIOUS DISEASE DOCTOR, TO USE A NEW CONVEX INSERT EACH TIME THAT THE WAFER IS CHANGED. THE END-USER WAS USING "SUR-FIT NATURA DISPOSABLE CONVEX INSERTS" WITH "SUR-FIT NATURA DURAHESIVE SKIN BARRIER W/FLANGE". THE "SUR-FIT NATURA DURAHESIVE SKIN BARRIER W/FLANGE" WAS CHANGED EVERY THREE (3) DAYS, AND END-USER WAS REUSING EACH CONVEX INSERT FOR EIGHTEEN (18) DAYS. THE AREA WAS WASHED WITH SOAP AND WATER PRIOR TO INSERTING A NEW WAFER. IT IS ALSO REPORTED THAT END-USER USED A NON-CONVATEC BRAND ADHESIVE REMOVER THEN APPLIED TURBO CEMENT, AND ALSO USED EAKIN COHESIVE SEALS BEFORE APPLYING WAFER. THE PRODUCT WAS IN USE FOR EIGHTEEN DAYS (18) BEFORE THE ISSUE OCCURRED. LASTLY, IT IS REPORTED THAT END-USER HAS BEEN DISCHARGED TO HOME NOW AND IS AFEBRILE AND STATES THAT HE IS DOING GOOD AND "I FEEL BETTER THAN I HAVE EVER FELT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327936 SUR-FIT NATURA 2 PC - DISPOSABLE CONVEX INSERT APPLIANCE, COLOSTOMY, DISPOSABLE EZS CONVATEC INC 404009 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R