BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) CONVEX MOLDABLE WAFER

    MDR report key: 4132810 · Received September 29, 2014

    Report

    Report Number
    1049092-2014-11325
    Event Type
    Injury
    Date Received
    September 29, 2014
    Report Date
    January 23, 2013
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO THE FDA 483 ISSUED (B)(4) 2014. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ANALYSIS IS TAKEN FROM A TRENDING REPORT OF EVALUATIONS OR ADVERSE EVENTS FINALIZED MAY 2011. THE DATA PRESENTED IS FROM THREE DIFFERENT PRODUCT APPLICATIONS. THE REPORT STATES THAT THERE ARE NO SIGNIFICANT TRENDS.

    Description of Event or Problem · 1

    PER THE END USER, CIRCUMFERENTIAL RED RASH AND ITCHING ON THE PERISTOMAL SKIN. CLEANSE SKIN WITH WATER, ALSO USES ADHESIVE REMOVER AND BARRIER WIPES. CHANGES SKIN BARRIER EVERY 2 DAYS. USER CREATED A HOLE PUNCH TO CUT THE OPENING OF THIS WAFER AND STARTED USING IT INSTEAD OF MOLDING HIS SKIN BARRIER TO FIT HIS STOMA APPROXIMATELY 2 WEEKS AGO. HE USED THIS HOLE PUNCH SO THE RED RASH LIKE WOULD NOT BE COVERED BY HIS SKIN BARRIER. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606957 S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) CONVEX MOLDABLE WAFER EXE CONVATEC, INC. 404593 2H02115

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK