BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2PC DURAHESIVE MOLDABLE WAFER

    MDR report key: 3761020 · Received April 11, 2014

    Report

    Report Number
    1049092-2014-00089
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    October 18, 2013
    Report Date
    March 18, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A SERIOUS INJURY. THE END USER REPORTED TO HAVE HAD USED MANY DIFFERENT TYPES OF PRODUCTS ON THESE WOUNDS. HE REPORTED THE USE OF ORAL PREDNISONE, TOPICAL COLLAGEN, XEROFORM GAUZE AND STOMAHESIVE POWDER. THE END USER INFORMED HE USES THE EAKIN SEAL WITH WAFER. HE FURTHER STATED HE HAS A SOFTBALL SIZED HERNIA UNDER HIS STOMA AND WEARS A HERNIA BELT. HE REPORTS SEEING A PHYSICIAN AND OSTOMY NURSE WEEKLY. HE INFORMED THAT HE IS WILLING TO TRY THE ONE PIECE POUCH DUE TO THE HERNIA TO RELIEVE PRESSURE FROM THE FLANGE AND HERNIA BELT. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(4) 2014.

    Description of Event or Problem · 1

    END USER REPORTS A SIX MONTH HISTORY OF TWO OPEN AREAS ABOVE AND BELOW HIS STOMA. THE TOP STOMA AREA IS 3.0 CM IN SIZE; BELOW STOMA AREA IS 2.5CM IN SIZE. THE END USER STATED THE AREAS DID DRAIN, BUT NOW THEY ARE NOT DRAINING. HE REPORTS THE AREAS WILL LOOK AS IF THEY ARE HEALING AND THEN REOPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220668 SUR-FIT NATURA 2PC DURAHESIVE MOLDABLE WAFER PROTECTOR, OSTOMY, 78EXE EXE CONVATEC INC 411804 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention