BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEW IMAGE TRANSPARENT CUT-TO-FIT CONVEX BARRIER

    MDR report key: 3813646 · Received May 15, 2014

    Report

    Report Number
    1119193-2014-00009
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 15, 2014
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    EXB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORDER FORM HAS BEEN FURTHER CLARIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED OSTOMY BARRIERS THAT WERE NOT OF THE CORRECT SIZE. THROUGH THE SECURE START SERVICE, THE CLINICIAN ORDERED ONE BOX OF 14403 NEW IMAGE CONVEX CUT TO FIT SKIN BARRIER FOR THE PATIENT. THE ORDER FORM WAS UNCLEAR IN THAT IT INDICATED THAT BOTH THE FLAT AND THE CONVEX BARRIER COULD BE CUT TO FIT OVER A SIZE RANGE OF 13-44MM. THE PATIENT'S STOMA MEASURED 41MM BUT THE CONVEX BARRIER CAN ONLY BE CUT UP TO 38MM. THE PATIENT CUT PAST THE INDICATED LIMIT AND DUE TO INCORRECT SIZING THE PATIENT PERISTOMAL SKIN BECAME RED AND EXCORIATED. THE PATIENT WAS READMITTED TO HOSPITAL AND IV ANTIBIOTICS WERE ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291368 NEW IMAGE TRANSPARENT CUT-TO-FIT CONVEX BARRIER OSTOMY EXB HOLLISTER INCORPORATED 14403

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention