BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2 PC DURAHESIVE CONVEX WAFER

    MDR report key: 4223673 · Received October 31, 2014

    Report

    Report Number
    1049092-2014-00572
    Event Type
    Injury
    Date Received
    October 31, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 23, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. NO ADDITIONAL PATIENT/EVENT DETAIL HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE END USER A THREE WEEK HISTORY OF RED RASH AND ITCHY SKIN UNDER THE TAPE BORDER. AREA AFFECTED IS TO THE LEFT UPPER CORNER OF WAFER, AWAY FROM STOMA. END USER REPORTS USING PERISTOMAL CLEANSER WIPES, RELIAMED ADHESIVE REMOVED, AND ALLKARE PROTECTIVE BARRIER WIPES. IT WAS FURTHER REPORTED THE END USER SAW PHYSICIAN ON (B)(6) 2014 AND WAS PRESCRIBED PRESCRIPTION CREAM DIPROLENE 1%. END USER REPORTS BEING UNABLE TO READ TUBE CLEARLY, HOWEVER HE WAS TOLD TO APPLY THIS TO AREA DAILY. PHYSICIAN ADVISED END USER TO DO THIS AFTER SHOWER, BEFORE APPLYING WAFER FOR 10 TO 15 MINUTES. END USER WAS ALSO INSTRUCTED ON CRUSTING TECHNIQUE WITH STOMAHESIVE POWDER AND ADVISED TO STOP RELIAMED WIPES AND PERISTOMAL WIPES TO SKIN AND TO USE ONLY MILD SOAP AND WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698191 SUR-FIT NATURA 2 PC DURAHESIVE CONVEX WAFER PROTECTOR, OSTOMY EXE CONVATEC, INC. 413181

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention METFORMIN| DIURETIC| STATIN FOR CHOLESTEROL| HEART MEDICATIONS| BLOOD PRESSURE MEDICINE