BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2 PC DURAHESIVE MOLDABLE WAFER

    MDR report key: 3884061 · Received June 9, 2014

    Report

    Report Number
    1049092-2014-00185
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 14, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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'S DAUGHTER CLEANSES HER FATHER'S SKIN WITH WARM WATER AND A MILD SOAP; APPLIES THE ANTI-FUNGAL POWDER; A NO-STING PROTECTIVE BARRIER WIPE AND THEN THE WAFER. END-USER'S DAUGHTER WAS PROVIDED INSTRUCTIONS IN SKIN CARE AND REINFORCED CRUSTING METHODS. LASTLY, SHE WAS ALSO INSTRUCTED TO NOTIFY CONVATEC WITH ANY QUESTIONS OR CONCERNS, IN ADDITION THEY WILL BE SENT A WAFER WITHOUT A TAPE BORDER. 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)(4) 2014. 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 RED, RAISED RASH AT THE RIGHT LOWER QUADRANT (RLQ) UNDER THE ADHESIVE TAPE BORDER THE WAFER. IT IS ALSO REPORTED THAT AFFECTED SITE IS TREATED WITH ANTI FUNGAL POWDER (FOOT POWDER) AS PRESCRIBED BY THE PRIMARY PHYSICIAN WHO BELIEVES ITS AN ALLERGIC REACTION RELATED TO THE ADHESIVE ON THE WAFER. PRODUCT HAS BEEN IN USE SINCE (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335299 SUR-FIT NATURA 2 PC DURAHESIVE MOLDABLE WAFER PROTECTOR, OSTOMY EXE CONVATEC INC 411800 3D00921

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention