BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAUCH LARYNGOSCOPE

    MDR report key: 724227 · Received May 18, 2006

    Report

    Report Number
    MW1039265
    Event Type
    Injury
    Date Received
    May 18, 2006
    Date of Event
    January 19, 2006
    Report Date
    May 18, 2006
    Manufacturer
    RAUCH
    Product Code
    CCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    BIOMED SERVICE TECHNICIAN REPORTED FAILURE TO RAUCH LARYNGOSCOPE HANDLE IN HOSP OR. OR STAFF REPORTED RED HOT HANDLE AND HAD TO DROP UNITS TO PREVENT SERIOUS BURNS. IMPACTED PT CARE. ISSUE: RAUCH 004413300 STUBBY HANDLE, LOT # 045106-1-2 AA BATTERY VERSION- PROBLEM: RED HOT HANDLE. HAD TO DROP OR RISK SERIOUS BURN FOR LARYNGOSCOPES OVERHEAT. ALERTED RECALL REP AT HOSP WHO CALLED IN SALESMAN OF TELEFLEX MEDICAL. CONTACTED RAUCH CO VIA A CONFERENCE CALL WITH RAUCH MANUFACTURING ON OR ABOUT 01/24/06.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAUCH LARYNGOSCOPE LARYNGOSCOPE CCW RAUCH 004413300 045106-1

    Patients

    Seq Age Sex Outcome Treatment
    1 * Disability