BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA 2 PC - DURAHESIVE CONVEX MOLDABLE WAFER

    MDR report key: 3950976 · Received July 14, 2014

    Report

    Report Number
    1049092-2014-00296
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 19, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. STATES SKIN CARE REGIMEN IS AS FOLLOWS: CLEANSES WITH WATER AND GAUZE; PATS DRY AND APPLIES EAKIN COHESIVE SEALS AND THE WAFER. STATES DID TRY SKIN PREP ONCE AND MAYBE ALLERGIC TO THAT SINCE SHE HAS HAD REACTIONS IN THE PAST. THE USE OF AN ANTI-FUNGAL POWDER WAS DISCUSSED WITH END-USER TO PROTECT SKIN FROM MOISTURE UNDER SKIN BARRIER AND THE ONSET OF SMALL BLISTER LIKE BUMPS AS REPORTED BY END-USER. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. CONVATEC 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 FOUR (4) DAYS AGO, THE END-USER DEVELOPED A RASH WITH ITCHING AND HIVES ON ONE SIDE OF THE STOMA LOCATED UNDER THE OSTOMY MASS. THIS HIVE LIKE RASH IS CURRENTLY BEING TREATED WITH KENALOG SPRAY FROM A PREVIOUS INFECTION WHICH WAS NOT PRESCRIBED FOR THIS CURRENT SKIN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410129 NATURA 2 PC - DURAHESIVE CONVEX MOLDABLE WAFER PROTECTOR, OSTOMY EXE CONVATEC INC. 404593 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention