BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2 PC DURAHESIVE CONVEX WAFER

    MDR report key: 4101111 · Received September 17, 2014

    Report

    Report Number
    1049092-2014-00482
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 31, 2014
    Report Date
    September 2, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON SEPTEMBER 14, 2015. NO PREVIOUS INVESTIGATIONS ARE AVAILABLE. AFTER A THOROUGH BATCH REVIEW, NO DISCREPANCIES OR NON-CONFORMANCES WERE FOUND. THERE IS NOT ENOUGH INFORMATION TO CONCLUDE THE PRODUCT DID NOT MEET SPECIFICATION AND PERFORM AS INTENDED. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. NO FURTHER ACTIONS ARE REQUIRED, AND THE COMPLAINT WILL BE CLOSED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE END-USER ADVISED THAT WHILE WORKING, HE LEANS UP AGAINST A MACHINE EXACTLY AT THE LEVEL OF HIS STOMA. THE END-USER WILL FOLLOW UP WITH HIS UROLOGIST AND SIZING OF THE WAFER WAS REVIEWED. HIS PERSONAL CARE PHYSICIAN WILL DISCUSS THE BENEFITS OF A STOMA GUARD. A SAMPLE WAS SENT. BASED ON THE AVAILABLE INTO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. NO FURTHER INFO WAS AVAILABLE AT THE TIME OF THE REPORT. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. REPORTED TO FDA ON (B)(4) 2014.

    Description of Event or Problem · 1

    THE END-USER REPORTED A CUT TO HIS STOMA LOCATED IN THE RIGHT LOWER QUADRANT WHILE AT WORK. HE WAS SEEN IN THE EMERGENCY DEPT WHERE THE PHYSICIAN PLACED SUTURES IN THE STOMA AND STOPPED THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576625 SUR-FIT NATURA 2 PC DURAHESIVE CONVEX WAFER EXE CONVATEC INC 413181 4F02909

    Patients

    Seq Age Sex Outcome Treatment
    1