BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4101757 · Received September 15, 2014

    Report

    Report Number
    1049092-2014-10982
    Event Type
    Injury
    Date Received
    September 15, 2014
    Report Date
    October 3, 2012
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO THE FDA 483 ISSUED APRIL 16, 2014. DEVICE (S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADD'L INFO 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 (B)(4) 2011. THE DATA PRESENTED IS FROM THREE DIFFERENT PRODUCT APPLICATIONS. THE REPORT STATES THAT THERE ARE NO SIGNIFICANT TRENDS. DEVICE MANUFACTURE DATE: UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT HAD DENUDED SKIN MEASURING APPROXIMATELY 23MM APPROX 19MM FROM HER STOMA AT THE 10 O'CLOCK SITE. THE PT DOES EXPERIENCE PAIN FROM THIS AREA WITH SMALL AMOUNTS OF SEROUS FLUID. SHE REPORTS HER MOLDABLE SKIN BARRIER TURTLE NECKS APPROX 75 PERCENT FROM HER STOMA. THE PT REPORTS THEY USUALLY CHANGE THE SKIN BARRIER EVERY 3 DAYS. THE PT USES VARIOUS METHODS TO CLEANSE THE AREA AND TO PROTECT THE "DENUDED" AREA. THE PT IS SEEN BY A HOME HEALTH NURSE AND WAS ENCOURAGED TO DISCUSS THE INCIDENT WITH THE NURSE. NO ADD'L INFO WAS PROVIDED. PT OUTCOME IS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569489 S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) MOLDABLE WAFER PROTECTOR, OSTOMY EXE CONVATEC, INC. 411802 2F00388

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention