BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA 2 PC ¿ DURAHESIVE CONVEX WAFER

    MDR report key: 3984979 · Received July 29, 2014

    Report

    Report Number
    1049092-2014-00360
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. SKIN CARE WAS REVIEWED WITH END-USER AND SAMPLES WILL BE SENT. 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 28, 2014; (B)(4). 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 WHO INDICATES THAT THEY HAVE VERY SENSITIVE SKIN DEVELOPED REDNESS AROUND THE STOMA SINCE HER SURGERY, AND WAS GIVEN A PRESCRIPTION FOR NYSTATIN FOR USE WITH EACH WAFER CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442659 NATURA 2 PC ¿ DURAHESIVE CONVEX WAFER PROTECTOR, OSTOMY; 78EXE EXE CONVATEC INC. 413181 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention