BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA DURAHESIVE SKIN BARRIER W / FLANGE (OVE

    MDR report key: 4462116 · Received January 28, 2015

    Report

    Report Number
    1049092-2015-00061
    Event Type
    Injury
    Date Received
    January 28, 2015
    Date of Event
    November 1, 2014
    Report Date
    December 2, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE END USER REPORTED HE DEVELOPED A RASH THAT HE DESCRIBED AS RED, ITCHY, PAINFUL, AND BLISTERING. THE RASH IS LOCATED UNDER HIS MASS, BUT CONFINED MOSTLY TO THE PERISTOMAL SKIN ON THE RIGHT SIDE OF HIS STOMA. THE END USER SOUGHT TREATMENT FROM HIS PHYSICIAN AND WAS DIAGNOSED WITH CONTACT DERMATITIS AND POSSIBLY CANDIDIASIS. THE END USER WAS ISSUED A PRESCRIPTION FOR CLOTRIMAZOLE AND BETAMETHASONE CREAM. THE END USER NOTED SOME IMPROVEMENT TO THE RASH WITH THE USE OF THE CLOTRIMAZOLE AND BETAMETHASONE CREAM; HOWEVER, THE RASH IS STILL PRESENT. THE PATIENT WAS ADVISED TO FOLLOW UP WITH HIS PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64720 NATURA DURAHESIVE SKIN BARRIER W / FLANGE (OVE PROTECTOR, OSTOMY EXE CONVATEC INC. 413155

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention LIPITOR| LUMIGAN