BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA® MOLDABLE DURAHESIVE® SKIN BARRIER

    MDR report key: 5153041 · Received October 15, 2015

    Report

    Report Number
    1049092-2015-00610
    Event Type
    Injury
    Date Received
    October 15, 2015
    Report Date
    September 24, 2015
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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. REPORTED TO THE FDA ON OCTOBER 15, 2015 (B)(4).

    Description of Event or Problem · 1

    END USER REPORTS HE DEVELOPED A PRESSURE ULCER WHILE USING A COMPETITOR'S PRODUCT. HE SWITCHED TO A CONVATEC WAFER AND THE ULCER HAS WORSENED. HE STATES THE ULCER IS OPEN SUPERFICIALLY LOCATED UNDER MASS AT 12 O'CLOCK POSITION AND MEASURES 38MM. HE CLEANS THE AREA WITH NORMAL STERILE SALINE. HE SOUGHT TREATMENT FROM WOUND AND STOMA DOCTORS WHO PERFORMED A BIOPSY OF THE AFFECTED AREA. TREATMENTS HAVE INCLUDED DRESSING THE ULCER WITH MEDLINE ALGINATE DRESSING. HIS CURRENT TREATMENT IS WITH HYDROFERA BLUE DRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684209 NATURA® MOLDABLE DURAHESIVE® SKIN BARRIER PROTECTOR, OSTOMY EXE CONVATEC INC. 411804

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention CONVATEC OSTOMY BELT