BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREEN RUSCHLITE DISP MTL MAC 3

    MDR report key: 4342721 · Received December 2, 2014

    Report

    Report Number
    1044475-2014-00360
    Event Type
    Malfunction
    Date Received
    December 2, 2014
    Date of Event
    October 1, 2014
    Report Date
    November 20, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE GRL BLADE DID NOT WORK OUT OF THE PACKAGE. A CLEAR PLASTIC SECTION AT THE BASE WAS MISSING. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776290 RUSCH GREEN RUSCHLITE DISP MTL MAC 3 LARYNGOSCOPE BLADE CCW TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1