BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOOTHETTE ORAL CARE SUCTION SWAB SYSTEM

    MDR report key: 394952 · Received May 14, 2002

    Report

    Report Number
    1419181-2002-00001
    Event Type
    Injury
    Date Received
    May 14, 2002
    Date of Event
    March 16, 2002
    Report Date
    April 15, 2002
    Manufacturer
    SAGE PRODUCTS, INC.
    Product Code
    JOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THAT SHORTLY AFTER THE PT. HAD BEEN ADMITTED TO THE CVICU, THE PATIENT "CODED", REQUIRING INTUBATION WITH AN ET TUBE AND WAS PLACED ON A VENTILATOR. REPORTER DESCRIBED THAT IN 2002 THERE HAD BEEN AN INTERNAL FACILITY REPORT OF A GREEN FOAM SWAB "COMING OFF THE STICK" DURING THE PT'S ORAL CARE. A PHYSICIAN EXAMINED THE PT., DETERMINED THE SWAB HAD BEEN SWALLOWED AND TOOK NO FURTHER ACTION. THIS OCCURRENCE WAS NOT REPORTED TO THE MANUFACTURER. IT WAS UNKNOWN IF BITE BLOCKS WERE IN PLACE DURING ORAL CARE. AFTER APPROXIMATELY A WEEK, DURING PLANNED EXTUBATION, HE REPORTEDLY EXPERIENCED RESPIRATORY DISTRESS REQUIRING RE-INTUBATION. AT SOME POINT DURING RE-INTUBATION, IT WAS REPORTED THAT 2 GREEN FOAM SWABS WERE NOTED IN THE PT.'S AIRWAY. THE POSITION IN THE AIRWAY, AS WELL AS HOW THEY WERE RETRIEVED WAS UNKNOWN, NOR WERE THEY KEPT FOR EVALUATION. IT WAS UNKNOWN HOW OR WHEN A SECOND SWAB ALLEGEDLY CAME OFF, AS NO INTERNAL FACILITY REPORT WAS MADE. REPORTEDLY, THE PT. WAS SUBSEQUENTLY TRACHED AND IS AGAIN ON A VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOOTHETTE ORAL CARE SUCTION SWAB SYSTEM SUCTION SWAB JOL SAGE PRODUCTS, INC. 6550 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| S