BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA DURAHESIVE SKIN BARRIER W/ FLANGE (OVE

    MDR report key: 4864898 · Received June 23, 2015

    Report

    Report Number
    1049092-2015-00363
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    January 1, 2010
    Report Date
    June 15, 2015
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 REPORTS SHE EXPERIENCES A BURNING SENSATION AND REDDENING OF HER SKIN UNDER THE MASS IMMEDIATELY SHE APPLIES THE WAFER TO HER SKIN. SHE WAS UNABLE TO PROVIDE DATE OF ONSET BUT STATES IT STATED APPROXIMATELY FIVE YEARS AGO. DURING THIS TIME SHE SOUGHT TREATMENT FORM HER PRIMARY PHYSICIAN WHO PRESCRIBED AN ANTIFUNGAL POWDER. HER PHYSICIAN HAS CONSISTENTLY RENEWED THE PRESCRIPTION FOR HER. THE END USER HAS DISCONTINUED USE OF THE PRODUCT AND TREATED THE AFFECTED AREA WITH ANTIFUNGAL POWDER, STOMAHESIVE POWDER AND ALLKARE BARRIER WIPES. THE REDNESS HAS SINCE RESOLVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406741 NATURA DURAHESIVE SKIN BARRIER W/ FLANGE (OVE PROTECTOR, OSTOMY EXE CONVATEC INC. 413155

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention MEDICATIONS: WELLBUTRIN XL, MYRBETRIQ