BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA 2 PC - DURAHESIVE (DH) CONVEX WAFER

    MDR report key: 3960348 · Received July 17, 2014

    Report

    Report Number
    1049092-2014-00310
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. IT IS REPORTED THAT END-USER CLEANSES THE AREA AS FOLLOWS: WASHES WITH WATER; PATS DRY; APPLIES A THIN DUODERM SPOT HYDROCOLLOID AND HAS SINCE SWITCHED TO A FLEXIBLE STOMAHESIVE ONE PIECE APPLIANCE. END-USER WAS INSTRUCTED TO CONTINUE WITH THE CURRENT TREATMENT AND TO SEE HIS SURGEON UPON HIS RETURN HOME FROM VACATION; IN ADDITION, HE WAS INSTRUCTED TO NOTIFY CONVATEC WITH ANY QUESTIONS OR CONCERN. LASTLY, END-USER HAS THROWN AWAY THE BOX; THEREFORE, THE LOT NUMBER IS NOT AVAILABLE. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. SHOULD ADD'L INFO BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4). THE ACTUAL DATE OF EVENT IS UNK, 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 APPROX SIX (6) MONTHS AGO, THE END-USER DEVELOPED A LITTLE ULCERATION WHICH BEGAN AT THE 6 O'CLOCK POSITION OF PERISTOMAL SKIN; TODAY END-USER REPORTS OF A LARGE ULCERATION DESCRIBED AS PAINFUL WITH A BLUISH HUE, EXTENDING FROM THE 3 O'CLOCK OF THE 6 O'CLOCK POSITION OF PERISTOMAL LOCATED UNDER THE CONVEX OSTOMY WAFER. IT IS FURTHER REPORTED THAT END-USER DOES NOT NEED CONVEXITY AND STOMA PROTRUDES APPROX UP TO ONE INCH. LASTLY, TREATMENT PROVIDED WITH A THIN DUODERM SPOT HYDROCOLLOID DRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420392 NATURA 2 PC - DURAHESIVE (DH) CONVEX WAFER PROTECTOR, OSTOMY EXE CONVATEC INC 413181 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention