BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEW IMAGE FLEXTEND BARRIER WITH TAPE BORDER

    MDR report key: 4113576 · Received September 24, 2014

    Report

    Report Number
    1119193-2014-00018
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    August 13, 2014
    Report Date
    September 24, 2014
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    EXB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONTRIBUTING FACTOR TO THE REPORTED BLEEDING EVEN COULD BE DUE TO THE PATIENT BEING ON BLOOD THINNERS. THE USER'S STOMA RETRACTS AND PROTRUDES ON IT'S OWN WHICH COULD HAVE CONTRIBUTED TO THE RUBBING AND RESULTING BLEEDING OF HIS STOMA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER EXPERIENCED BLEEDING FROM HIS STOMA WHICH HE BELIEVES WAS A RESULT OF THE LOWER EDGE OF THE BARRIER RUBBING AGAINST HIS STOMA. HE WENT TO THE ER TO ADDRESS THE BLEEDING AS IT WOULD NOT STOP ON ITS OWN. HE STATED THAT HE HAS ALWAYS HAD A VERY VASCULAR STOMA AND HAD BEEN STARTED ON PLAVIX JUST SIX WEEKS PRIOR. THE USER HAS A HISTORY OF KIDNEY STONES AND IS ON PLAVIX FOR HIS TWO CARDIAC STENTS. THE ER NURSE WHO WAS REAPPLYING HIS APPLIANCE AFTER THE CAUTERIZATION FELT THE BARRIER WAS FITTING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595588 NEW IMAGE FLEXTEND BARRIER WITH TAPE BORDER OSTOMY EXB HOLLISTER INCORPORATED 14706

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention