BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S4S/SUR-FIT NATURA 2OC-2OC DYRAGESUVE (DH) CONVEX MOLDABLE WAFER

    MDR report key: 4059032 · Received August 20, 2014

    Report

    Report Number
    1049092-2014-10838
    Event Type
    Injury
    Date Received
    August 20, 2014
    Report Date
    July 31, 2012
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. IT IS NOTED THAT THERE ARE BLANK AREAS ON THIS FORM, THE INFO WAS NOT PROVIDED OR IS UNK. 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

    REPORT PROVIDED BY THE END USER STATES THAT THEY ARE EXPERIENCING A RASH UNDER THE TAPE COLLAR AND MASS. OCCURRED DURING THE SUMMER MONTHS. PLANS TO ADD THE USE OF AN OSTOMY POWDER. THE CRUSTING TECHNIQUE WAS REVIEWED. THE END USER DECLINED AN OFFER TO SHIP THEM ALTERNATE SAMPLES, STATING THAT SHE WOULD ONLY CHANGE IF INSTRUCTED TO DO SO BY THEIR LOCAL OSTOMY CLINIC. THE PTS SUBSEQUENT OUTCOME WAS NOT NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503760 S4S/SUR-FIT NATURA 2OC-2OC DYRAGESUVE (DH) CONVEX MOLDABLE WAFER PROTECTOR, OSTOMY EXE CONVATEC INC. 404594

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention