BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2 PC (SH) WAFER W/FLEX COLLAR

    MDR report key: 3884106 · Received June 9, 2014

    Report

    Report Number
    1049092-2014-00180
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K830945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. IT IS REPORTED THAT END-USER CLEANSES SKIN WITH WATER THEN DRIES. 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 (B)(6), 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 DEVELOPED A RASH FIVE (5) YEARS AGO LOCATED AT THE RIGHT LOWER QUADRANT (RLQ) UNDER THE STOMAHESIVE MASS AND TAPE COLLAR AND UNDER POUCH, WHICH STARTED AS A BLISTERED RED AREA. A BIOPSY WAS PERFORMED CONFIRMING AN ALLERGIC REACTION WITH TREATMENT OF ANTIFUNGAL POWER AND CORTISONE INJECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335360 SUR-FIT NATURA 2 PC (SH) WAFER W/FLEX COLLAR PROTECTOR, OSTOMY EXE CONVATEC INC. 125271 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention