BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA 2 PC DURAHESIVE CONVEX MOLDABLE WAFER

    MDR report key: 4024578 · Received August 1, 2014

    Report

    Report Number
    1049092-2014-00385
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 2014
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. CONVATEC IS SENDING STOMAHESIVE SKIN BARRIER SAMPLES 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. REPORTED TO THE FDA ON AUGUST 1, 2014. 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 END-USER'S ABDOMINAL SKIN PRESENTED WITH REDNESS, BUMPS WITH ITCHING ASSOCIATED WITH THE OSTOMY TAPE COLLAR ABOUT TWO WEEKS AGO. IT IS FURTHER REPORTED THAT END-USER HAS NOT SEEN A DOCTOR BUT HAD SOME NYSTATIN POWDER AND HAS APPLIED TWO APPLICATIONS WITHOUT MUCH IMPROVEMENT. LASTLY, END-USER DID CONTACT HER DOCTOR FOR A RENEWAL OF THE NYSTATIN PRESCRIPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451297 NATURA 2 PC DURAHESIVE CONVEX MOLDABLE WAFER PROTECTOR, OSTOMY, 78EXE EXE CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C. 404593 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention