BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREENSPEC FO HANDLE SMALL

    MDR report key: 4240157 · Received October 29, 2014

    Report

    Report Number
    1044475-2014-00297
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 10, 2014
    Manufacturer
    TELEFLEX
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE BLADE WILL NOT FIT PROPERLY ON THE HANDLE (LOOSE). THE ISSUE WAS DETECTED DURING PRE-TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693218 RUSCH GREENSPEC FO HANDLE SMALL LARYNGOSCOPE HANDLE CCW TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1