BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA 2 PC DURAHESIVE CONVEX WAFER

    MDR report key: 3976210 · Received July 21, 2014

    Report

    Report Number
    1049092-2014-00323
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K855014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. SAMPLES WERE SENT TO END-USER. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT LAST MONTH THE END-USER DEVELOPED AN ULCER LOCATED UNDER WAFER'S MASS TO THE LEFT OF THE STOMA OF PERISTOMAL SKIN. IT IS FURTHER REPORTED THAT THE END-USER WILL BE SEEING A WOUND OSTOMY AND CONTINENCE NURSE (WOCN) IN TWO (2) DAYS FOR TREATMENT OPTIONS USING AN ANTIBIOTIC POWDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425607 NATURA 2 PC DURAHESIVE CONVEX WAFER PROTECTOR, OSTOMY EXE CONVATEC INC. 413179 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention