BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 772874 · Received October 24, 2006

    Report

    Report Number
    2936999-2006-00832
    Event Type
    Injury
    Date Received
    October 24, 2006
    Date of Event
    October 1, 2006
    Report Date
    October 4, 2006
    Manufacturer
    JUAREZ HENEQUEN
    Product Code
    KAC
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS REPORT IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    ON 10/04/06, NELLCOR REC'D A REPORT WHERE IT WAS CLAIMED "LEAKAGE BETWEEN INNER AND OUTER CANNULA" WHILE IN USE ON A PT. REPLACEMENT OF THE TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY LARYNGECTOMY KAC JUAREZ HENEQUEN LGT 0308000359

    Patients

    Seq Age Sex Outcome Treatment
    1 *