BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA 2 PC - STOMAHESIVE WAFER W/FLEX COLLAR

    MDR report key: 3979924 · Received July 24, 2014

    Report

    Report Number
    1049092-2014-00347
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 29, 2014
    Report Date
    July 8, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    EXE
    PMA / PMN Number
    K830945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. THE END-USER WAS ADVISED TO FOLLOW UP WITH THE DOCTOR OR VISIT THE EMERGENCY ROOM AS NEEDED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON 07/25/2014. 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 THE END-USER EXPERIENCED BLEEDING (EXTENT OF THE BLEED CANNOT BE DETERMINED), FROM THE STOMA TEN (10) DAYS AGO AFTER TWO (2) DAYS OF PRODUCT USE. IT IS FURTHER REPORTED THAT THE BLEED HAS STOPPED AND IS RELATED TO THE APPLICATION OF A HOLLISTER SPRAY. LASTLY, THE END-USER HAS CONTACTED A PHYSICIAN AND IS WAITING FOR A RETURN CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435155 NATURA 2 PC - STOMAHESIVE WAFER W/FLEX COLLAR PROTECTOR, OSTOMY 78EXE EXE CONVATEC INC 125272 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention