BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2PC DH CONVEX MOLDABLE WAFER

    MDR report key: 3862762 · Received May 27, 2014

    Report

    Report Number
    1049092-2014-00153
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 7, 2014
    Report Date
    May 5, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY BASED ON THE PATIENT REQUIRING PRESCRIPTIONS FROM DERMATOLOGIST, MD. IT IS REPORTED THAT END-USER'S SKIN CARE ROUTINE IS TO CLEAN WITH SALINE, APPLY (B)(6) DRESSING TO THE WOUND, AND (B)(6) PASTE AND 12 O'CLOCK AND 6 O'CLOCK POSITION. COMPLAINT HAS CONFIRMED THAT PRODUCT LOT NUMBER IS NOT AVAILABLE AND NOT ABLE TO BE RETRIEVED. DOES NOT WISH TO TRY ALTERNATIVE SAMPLES AT PRESENT. LASTLY, SHE WAS ENCOURAGED TO FOLLOW-UP WITH HEALTH CARE PROFESSIONAL. NO OTHER INFORMATION IS AVAILABLE AT PRESENT. OUTBOUND CALL ATTEMPT TO END USER @1558 LEFT MESSAGE. ON (B)(4) 2014, @2015, TERRITORY MANAGER PLACED FOLLOW-UP OUTBOUND CALL. NO ADDITIONAL PATIENT/ EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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 A CALL WAS RECEIVED FROM A DERMATOLOGIST, MD ADVISING THAT THE END-USER HAS A WOUND UNDER THE OSTOMY WAFER. IT IS ALSO REPORTED THAT END-USER DISCONTINUED USE OF HER SUR-FIT NATURA DURAHESIVE MOLDABLE CONVEX SKIN BARRIER W/FLANGE W/WHITE TAPE COLLAR AND MOLD-TO-FIT OPENING AFTER ABOUT THREE DAYS OF USE AND RETURNED TO USING THE SUR-FIT NATURA MOLDABLE DURAHESIVE SKIN BARRIER W/HYDROCOLLOID FLEXIBLE COLLAR AND MOLD-TO-FIT OPENING, AND VISITED HER SURGEON AND WOCN ABOUT 3 WEEKS AGO. THE WOCN APPLIED STOMAHESIVE POWDER AND BLOTTED WITH BARRIER WIPE AND APPLIED (B)(6) DRESSING AND HER NON CONVEX APPLIANCE (SUR-FIT NATURA MOLDABLE DURAHESIVE SKIN BARRER W/ HYDROCOLLOID FLEXIBLE COLLAR AND MOLD-TO-FIT OPENING). THE END-USER WAS EVALUATED BY THE DERMATOLOGIST, MD ON (B)(6) 2014, WHO TREATED THE SITE WITH A TOPICAL OINTMENT TO THE WOUND AND AN UNKNOWN CLEAR GEL TO THE PERIWOUND SKIN, THE AQUACEL DRESSING AND HER APPLIANCE (SUR-FIT NATURA MOLDABLE DURAHESIVE SKIN BARRIER W/ HYDROCOLLOID FLEXIBLE COLLAR AND MOLD-TO-FIT OPENING). LASTLY, IT IS REPORTED THAT END-USER IS SCHEDULED FOR A FOLLOW-UP WITH HER SURGEON IN ONE WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311956 SUR-FIT NATURA 2PC DH CONVEX MOLDABLE WAFER 78 EXE EXE CONVATEC INC 404592 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention