BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4100732 · Received September 12, 2014

    Report

    Report Number
    1049092-2014-11450
    Event Type
    Injury
    Date Received
    September 12, 2014
    Report Date
    March 12, 2013
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE PRODUCT WAS MADE ACCORDING TO SPECIFICATION BASED ON THE RESULTS OF THIS INVESTIGATION. THE QUALITY SYSTEMS IN PLACE ARE APPROPRIATE TO PREVENT DEFECTS FROM OCCURRING OR DETECT DEFECTS IN THE EVENT OF OCCURRENCE. FUTURE COMPLAINTS WILL BE MONITORED.

    Description of Event or Problem · 1

    REPORT PROVIDED BY THE END USER STATES THAT THEY HAVE NOTED A WHITE SPOT ON STOMA. THE END USER ALSO STATES THAT THE STOMA IS RUBBING AGAINST THE FLANGE. THE END USER'S SUBSEQUENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565116 S4S/SUR-FIT NATURA 2PC-2PC DURAHESIVE (DH) CONVEX MOLDABLE WAFER PROTECTOR, OSTOMY EXE CONVATEC, INC. 404594 2L01290

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention