BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION

    MDR report key: 422797 · Received October 15, 2002

    Report

    Report Number
    1038445-2002-00001
    Event Type
    Malfunction
    Date Received
    October 15, 2002
    Date of Event
    October 1, 2002
    Report Date
    October 8, 2002
    Manufacturer
    TRI-STATE HOSPITAL SUPPLY CORP.
    Product Code
    EFW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN ORAL SWAB WAS USED ON AN ELDERLY PT. THE FOAM (SPONGE) CAME OFF THE STICK AND OBSTRUCTED THE PT'S AIRWAY. THE PT WAS CODED, CODE BLUE. DURING A FOLLOW-UP TO THE INCIDENT IN 2002, THE NURSING DIRECTOR, INFORMED TRI-STATE SALES REP, THAT THE PT HAD SURVIVED. ALL MC505 PRODUCT WAS REMOVED FROM THE FLOORS. THE HOSP IS RETAINING THE SWABSTICK INVOLVED IN THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTURION MOUTH CARE KIT EFW TRI-STATE HOSPITAL SUPPLY CORP. * 507292

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening