BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDOTRACHEAL TUBE HOLDER

    MDR report key: 2503895 · Received March 21, 2012

    Report

    Report Number
    2523148-2012-00001
    Event Type
    Other
    Date Received
    March 21, 2012
    Manufacturer
    PRECISION MEDICAL, INC.
    Product Code
    CBH
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PT WAS TRANSFERRED FROM (B)(6) HOSP TO (B)(6) HOSP WITH THE DEVICE IN PLACE. THE PT WAS CHECKED 4 HOURS AFTER BEING ADMITTED INTO (B)(6), AND THE BLISTER WAS FOUND. COMMENTS FROM (B)(6) STATES THAT UNK HOW LONG THE DEVICE WAS IN PLACE WITHOUT BEING CHECKED, BEFORE (B)(6) ARRIVAL. APPEARS TO BE A FAILURE TO ADJUST AND EVALUATE THE PT WHILE WEARING THE ENDOTRACHEAL TUBE HOLDER. NOT A DEVICE PROBLEM.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTRACHEAL TUBE HOLDER ENDOTRACHEAL TUBE HOLDER CBH PRECISION MEDICAL, INC. PM1110 ADCDCABB

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR