BEUDAMED
    FDA Adverse Event Death Summary report: N

    FOCS BLADES, STANDARD HANDLE

    MDR report key: 214885 · Received March 16, 1999

    Report

    Report Number
    2429473-1999-00013
    Event Type
    Death
    Date Received
    March 16, 1999
    Date of Event
    February 20, 1999
    Report Date
    March 15, 1999
    Manufacturer
    RUSCH INC.
    Product Code
    EQN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING USE, BLADES GAVE INTERMITTANT LIGHT. IT WAS FURTHER REPORTED THAT THE ALLEGED PRODUCT WAS USED ON A TRAUMA PT, WHO THE HEALTHCARE PROFESSIONAL TERMED AS "NOT VIABLE; ABOUT DEAD ON ARRIVAL." IT WAS REPORTED THAT THE PT DEATH WAS NOT DUE TO THE ALLEGED DEFECTIVE PRODUCT BUT RATHER DUE TO THE TRAUMA SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOCS BLADES, STANDARD HANDLE LARYNGOSCOPE BLADES AND HANDLES EQN RUSCH INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death