BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION

    MDR report key: 162830 · Received April 9, 1998

    Report

    Report Number
    1824619-1998-90001
    Event Type
    Malfunction
    Date Received
    April 9, 1998
    Date of Event
    March 8, 1998
    Report Date
    March 16, 1998
    Manufacturer
    TRI-STATE HOSPITAL SUPPLY CORP.
    Product Code
    EFT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ORAL SWAB WAS USED ON PT'S THROAT. FOAM (SPONGE) CAME OFF STICK AND WAS ASPIRATED BY PT. PT STROKE AFTER THIS EVENT. TESTED OTHER ORAL SWABS. MOISTURE WOULD LOOSEN FOAM, AND IT WOULD SLIP OFF. ALL CENTURION MC200 MOUTH CARE KITS WERE PULLED FROM FLOORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTURION MOUTH CARE KIT EFT TRI-STATE HOSPITAL SUPPLY CORP. * 01268

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening| R