BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA 2 PC DH ACRYLIC COLLAR MOLDABLE WAFER

    MDR report key: 3971253 · Received July 9, 2014

    Report

    Report Number
    1049092-2014-00282
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    CONVATEC
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THE EVENT IS BEING REPORTED AS A SERIOUS INJURY AS IT IS NOT POSSIBLE TO DISCERN HOW MUCH BLOOD WAS LOST OR THE EXACT SOURCE OF THE BLEEDING, STOMA, SKIN OR FISTULA. IT IS REPORTED THAT THE END-USER WAS ADVISED TO APPLY PRESSURE FOR FIVE MINUTES; HOWEVER, THE END USER HAD TO DISCONNECT THE CALL DUE TO OUTPUT AND THE NEED TO APPLY PRESSURE. END-USER WAS FURTHER ADVISED IF BLOOD IS IN POUCH THEN HE WILL NEED TO SEEK MEDICAL ATTENTION. LASTLY, HEIGHT AND WEIGHT WAS NOT OBTAINED FROM END-USER, BECAUSE HE HAD TO STOP CALL AND THE USE OF THE MOLDABLE WAFER WAS REVIEWED IN THAT END-USER MAY NEED TO TRY CUT TO FIT THE WAFER, SINCE MUCUS FISTULA IS ONLY PROTRUDING ONE EIGHT OF AN INCH. 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. REPORTED TO THE FDA ON JULY 08, 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 END-USER PRESENTED WITH BLEEDING FROM AREA OF MUCUS FISTULA WHICH IS ATTACHED AND LOCATED ABOVE STOMA WHICH STARTED WITHIN THE LAST HOUR. IT IS FURTHER REPORTED THAT THE END-USER REMOVED THE WAFER AND WAS UNABLE TO TELL IF BLOOD IS COMING FROM STOMA ITSELF OR WHERE SKIN AND STOMA MEET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400199 NATURA 2 PC DH ACRYLIC COLLAR MOLDABLE WAFER PROTECTOR, OSTOMY EXE CONVATEC 413419 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention