BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA 2 PC - STOMAHESIVE (SH) MOLDABLE WAFER

    MDR report key: 4009805 · Received July 3, 2014

    Report

    Report Number
    1049092-2014-00265
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K830945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY BASED ON PATIENT REQUIRING PRESCRIPTION MEDICATION TO TREAT THIS RASH. REPORT STATES THAT END-USER HAS BEEN USING NYSTOP POWDER FOR AWHILE, AND WAS SUGGESTED USING STOMAHESIVE POWDER INSTEAD. NO ADDITIONAL PT/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 07/02/2014. NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DAE CONVATEC BECOME 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 DEVELOPED A RASH TO THE PERISTOMAL SKIN LOCATED UNDER THE OSTOMY WAFER AFTER ONE (1) DAY OF USE, AND WAS PRESCRIBED PRESCRIPTION NYSTOP POWDER TO TREAT THIS RASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392144 NATURA 2 PC - STOMAHESIVE (SH) MOLDABLE WAFER PROTECTOR, OSTOMY, 78EXE EXE CONVATEC INC. 11805 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention