BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S2S/SUR-FIT NATURA 2 PC - 2 PC UROSTOMY POUCH W/ ACCUSEAL TAP

    MDR report key: 4202376 · Received September 17, 2014

    Report

    Report Number
    9618003-2014-10720
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Report Date
    May 31, 2012
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC, INC.
    Product Code
    EXH
    PMA / PMN Number
    K840166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 ADDITIONAL INFORMATION 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 INFORMATION WAS NOT PROVIDED OR IS UNKNOWN. A REVIEW OF NON CONFORMANCES RELATED TO THIS COMPLAINT INVESTIGATION WAS CONDUCTED. AS A RESULT THERE WAS NO EVIDENCE THAT ANY OF THE MANUFACTURING PROCESSES AND PROCEDURES PERFORMED CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    REPORT PROVIDED BY THE END USER STATES THAT THEY HAVE EXPERIENCED THAT URINE WILL NOT DRAIN THROUGH THE PRODUCTS ANTI-REFLUX VALVE INTO THE POUCH. THE END USERS SUBSEQUENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575221 S2S/SUR-FIT NATURA 2 PC - 2 PC UROSTOMY POUCH W/ ACCUSEAL TAP URINARY, ILEOSTOMY EXH CONVATEC DOMINICAN REPUBLIC, INC. 401544 1G01698

    Patients

    Seq Age Sex Outcome Treatment
    1