BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DALE STABILOCK ENDOTRACHEAL TUBE HOLDER

    MDR report key: 1355040 · Received March 24, 2009

    Report

    Report Number
    1214422-2009-00002
    Event Type
    Injury
    Date Received
    March 24, 2009
    Date of Event
    January 23, 2009
    Report Date
    March 23, 2009
    Manufacturer
    DALE MEDICAL PRODUCTS, INC.
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RISK MANAGER NOTES THAT PRIOR TO APPLYING THE DALE 270 ET HOLDER A SKIN BREAKDOWN ON THE LEFT SIDE OF THE PT'S LIP WAS NOTICED. THERE ARE CONFLICTING REPORTS WHETHER TONGUE NECROSIS WAS OBSERVED AT THIS TIME. THE ENDOTRACHEAL TUBE'S SUPPORTING TAPE WAS REMOVED AND THE DALE 270 ET HOLDER WAS USED INSTEAD. THE VENTILATOR TUBE HAD NOT BEEN SUPPORTED AND ACCORDING TO THE PT'S CHART, IT WAS NOT EVIDENT HOW OFTEN THE ET TUBE WAS REPOSITIONED. THE OUTCOME AND TREATMENT IS UNKNOWN AS THE PT WAS TRANSFERRED TO ANOTHER HOSPITAL WHERE HEART TRANSPLANTS ARE PERFORMED. DALE LABELING: CAUTION: TO PREVENT SKIN ULCERATIONS OR SKIN TEARS, ASSESS PT SKIN AND MEDICAL CONDITION PRIOR TO APPLYING. MONITOR DAILY OR MORE FREQUENTLY. REMOVAL: ADHESIVE SHOULD BE REMOVED WITH CARE TO AVOID SKIN TRAUMA. DALE MEDICAL STRONGLY RECOMMENDS SUPPORTING THE VENTILATOR TUBING TO REDUCE PRESSURE ON THE PT'S FACE. DALE MEDICAL RECOMMENDS REPOSITIONING THE ENDOTRACHEAL TUBE OFTEN TO HELP PREVENT INJURY TO THE LIPS AND UNDERLYING TISSUES DUE TO UNRELIEVED PRESSURE. REFERENCE: ACCORDING TO UPDATED GUIDELINES WRITTEN BY THE GERONTOLOGICAL NURSING AND SUMMARIZED: ICU PATIENTS WHOSE CONDITION IS UNSTABLE SHOULD BE REASSESSED EVERY SHIFT.

    Description of Event or Problem · 1

    MEDWATCH ISSUED BY A HOSPITAL RECEIVED. IN 2009. THE MEDWATCH DOCUMENT DESCRIBED THE EVENT AS: DURING ENDOTRACHEAL TUBE TAPE CHANGE & REPOSITIONING OF THE TUBE, IT WAS FOUND THE PT'S TONGUE TO BE NECROTIC WITH SKIN BREAKDOWN ALSO NOTED TO THE LEFT SIDE OF THE PATIENT'S MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DALE STABILOCK ENDOTRACHEAL TUBE HOLDER DALE 270 ET TUBE HOLDER CBH DALE MEDICAL PRODUCTS, INC. 270 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other