BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOMAHESIVE PASTE/POWDER/STRIP

    MDR report key: 4101157 · Received September 17, 2014

    Report

    Report Number
    1049092-2014-11470
    Event Type
    Injury
    Date Received
    September 17, 2014
    Report Date
    March 18, 2013
    Manufacturer
    CONVATEC, INC
    Product Code
    EXE
    PMA / PMN Number
    K803100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 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

    REPORT PROVIDED BY THE END USERS WIFE STATES THAT THE END USER HAS EXPERIENCED REDNESS JUST UNDER THE PASTE. THE END USER BELIEVES THAT THEY ARE SENSITIVE TO PASTE. THE END USERS SUBSEQUENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576821 STOMAHESIVE PASTE/POWDER/STRIP PROTECTOR, OSTOMY EXE CONVATEC, INC 183910 2J00784

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention