BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENVER SPLINT, SERIES 1500

    MDR report key: 755828 · Received August 16, 2006

    Report

    Report Number
    755828
    Event Type
    Malfunction
    Date Received
    August 16, 2006
    Date of Event
    August 9, 2006
    Report Date
    August 15, 2006
    Manufacturer
    SHIPPERT MEDICAL TECHNOLOGIES
    Product Code
    EPP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON APPLIED DENVER SPLINT TO PATIENT'S NOSE. WHILE DOING SO, NOTED THE TAN (BEIGE) PAINT WAS FLAKING OFF THE SPLINT. BECAUSE THE SURGEON HAD ALREADY ADHERED THE SPLINT AND MOLDED IT TO SHAPE, HE CHOSE NOT TO REMOVE THIS ONE AND REPLACE IT WITH ANOTHER. THERE WERE NO PAINT FLAKES OBSERVED IN PATIENT'S EYE AREA. EARLIER THIS YEAR, WE REPORTED THE SAME PROBLEM WITH FLAKING PAINT FROM THE DENVER SPLINT. AFTER THE EARLIER OCCURRENCE THE MANUFACTURER WAS CONTACTED AND DID INDICATE AWARENESS OF THIS PROBLEM. IN RESPONSE, MANUFACTURER REQUESTED THAT WE REPLACE OUR STOCK WITH A NEW SUPPLY AND THIS WAS DONE. AFTER THIS OCCURRENCE, AGAIN MANUFACTURER WAS CONTACTED. MANUFACTURER AGAIN REQUESTED THAT WE PULL CURRENT STOCK AND REPLACE WITH A NEW SUPPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENVER SPLINT, SERIES 1500 SPLINT, NASAL EPP SHIPPERT MEDICAL TECHNOLOGIES * 10030

    Patients

    Seq Age Sex Outcome Treatment
    1 *