BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4101759 · Received September 15, 2014

    Report

    Report Number
    1049092-2014-10971
    Event Type
    Injury
    Date Received
    September 15, 2014
    Report Date
    September 28, 2012
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 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

    IT WAS REPORTED THAT A PT HAD CIRCUMFERENTIAL RED RASH TYPE AREA UNDER THE COLLAR OF AN APPLIANCE AFTER IT HAD BEEN IN PLACE FOR 5 DAYS. THE PT STATED THEY DID NOT APPLY THE MOLDABLE SKIN BARRIER BUT INSTEAD APPLIED HER PREVIOUS SKIN BARRIER WITH TAN TAPE COLLAR AND CHANGED IT AGAIN IN 5 DAYS AT WHICH TIME THE REDNESS HAD DECREASED. PT OUTCOME IS REPORTED AS THE PT APPLIED THE SKIN BARRIER AGAIN AND BY THE TIME IT WAS CHANGED AGAIN IN 5 DAYS THE REDNESS HAD RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570302 S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) MOLDABLE WAFER PROTECTOR, OSTOMY EXE CONVATEC, INC. 411802 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention