BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESTEEM 1PC - 1PC DRAINABLE INVISICLOSE DRAINABLE POUCH APS

    MDR report key: 4100731 · Received September 12, 2014

    Report

    Report Number
    9618003-2014-11448
    Event Type
    Injury
    Date Received
    September 12, 2014
    Report Date
    March 11, 2013
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC, INC.
    Product Code
    EZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 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

    REPORT PROVIDED BY THE END USER STATES THAT THEY HAVE EXPERIENCED POOR ADHESION OF THE WAFER TO SKIN. THE END USER THINKS THERE IS A BLISTER BETWEEN THE WAFER AND THE RELEASE PAPER, THE ADHESION BECAME POOR. THE END USER REQUESTED AN INVESTIGATION OF THE ADHESION OF THE WAFER WITH BLISTER. THE END USER SUBSEQUENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565159 ESTEEM 1PC - 1PC DRAINABLE INVISICLOSE DRAINABLE POUCH APS PROTECTOR, OSTOMY EZQ CONVATEC DOMINICAN REPUBLIC, INC. 416718 2C01321

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention