BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2 PC DURAHESIVE MOLDABLE WAFER

    MDR report key: 3884085 · Received June 9, 2014

    Report

    Report Number
    1049092-2014-00186
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 15, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 WANTED TO KNOW IF HE CAN TAKE A BATH TODAY, BUT HE WAS ADVISED BY CONVATEC TO FIRST CONTACT HIS UROLOGIST FOR INSTRUCTIONS, AND WAS ENCOURAGED TO CONTACT HIS PRIMARY PHYSICIAN AND TO FOLLOW-UP WITH UROLOGIST AS NEEDED. 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. 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 NOTICED BLOOD IN THIS URINE. HE REMOVED HIS WAS WAFER AND NOTED STRINGS OF BLOOD AT THE BASE OF HIS STOMA. THEY HAVE BEEN STRETCHING THE OPENING OF THE MOLDABLE SKIN BARRIER TO FIT HIS STOMA INSTEAD OF ROLLING IT BACK. END-USER WAS PROVIDED INSTRUCTIONS ON HOW TO MOLD THE OPENING TO FIT HIS STOMA. NO BLEEDING NOTED AT THIS TIME. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2014 FROM END-USER'S WIFE WHO REPORTED THAT END-USER HAD BLEEDING FROM THE STOMA ON (B)(6) 2014 THAT REQUIRED DIRECT PRESSURE AND CAUTERIZATION WITH SILVER NITRATE TO THE STOMAL MUCOSAL TISSUE, BY THE PRIMARY DOCTOR ON (B)(6) 2014. THE NEXT DAY, ON (B)(6) 2014, THE END-USER WAS SEEN BY THE UROLOGIST WHO PLACED TWO (2) STITCHES TO THE RIGHT LOWER QUADRANT (RLQ)/10 O'CLOCK POSITION OF PERISTOMAL SKIN. LASTLY, END-USER'S WIFE REPORTS THAT END-USER'S SKIN IS CLEAR AND THERE HAS BEEN NO FURTHER BLEEDING SINCE THEN. IT IS REPORTED THAT PRODUCT WAS IN USE FOR 1.5 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335427 SUR-FIT NATURA 2 PC DURAHESIVE MOLDABLE WAFER PROTECTOR, OSTOMY EXE CONVATEC INC. 411802 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention