BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2 PC DURAHESIVE WAFER

    MDR report key: 3402943 · Received October 7, 2013

    Report

    Report Number
    1049092-2013-00086
    Event Type
    Injury
    Date Received
    October 7, 2013
    Date of Event
    August 9, 2013
    Report Date
    September 9, 2013
    Manufacturer
    CONVATEC INC.
    Product Code
    EXB
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION THIS EVENT IS DEEMED A SERIOUS INJURY. THE END USER STATED HE CHANGES HIS WAFER EVERY 1-4 DAYS, CLEANSES HIS PERISTOMAL SKIN WITH IVORY SOAP, USES RELIAMED PROTECTIVE BARRIER WIPES FOLLOWED BY PREMIUM POWDER BY HOLLISTER TO HIS PERISTOMAL SKIN. THE END USER ALSO STATED HE USES STOMAHESIVE PASTE ON HIS PERISTOMAL SKIN. THE END USER PUT HYDROGEN PEROXIDE ON THE OPEN AREA AND WAS ALSO INSTRUCTED ON CRUSTING WITH STOMA POWDER, SKIN PROTECTIVE BARRIER WIPES OR WATER. FROM A CLINICAL PERSPECTIVE, A CAUSAL RELATIONSHIP BETWEEN THE SUR-FIT NATURA 2 PC DURAHESIVE WAFER AND THIS EVENT IS DEEMED POSSIBLE BECAUSE PRODUCT USE IS TEMPORALLY ASSOCIATED WITH THE SKIN WHERE THE PROBLEM OCCURRED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. REPORTED TO THE FDA ON (B)(4) 2013.

    Description of Event or Problem · 1

    END USER CALLED IN TO REPORT STRIPPING HIS SKIN ON THE RIGHT SIDE OF HIS PERISTOMAL SKIN UPON REMOVING HIS WAFER APPROXIMATELY 1 MONTH AGO. THE END USER STATED THIS AREA MEASURES LESS THAN 13 MM IN CIRCUMFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506877 SUR-FIT NATURA 2 PC DURAHESIVE WAFER PROTECTOR, OSTOMY EXB CONVATEC INC. 413155 3D03216

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention