BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREENSPEC FO HANDLE SMALL

    MDR report key: 4780539 · Received May 18, 2015

    Report

    Report Number
    1044475-2015-00163
    Event Type
    Malfunction
    Date Received
    May 18, 2015
    Date of Event
    April 17, 2015
    Report Date
    April 27, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NEVER RETURNED FOR EVALUATION; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. IF THE SAMPLE IS RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE HANDLE WOULD NOT LIGHT UP DURING PRE-TESTING. NO REPORT OF PT INJURY.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE HANDLE WOULD NOT LIGHT UP DURING PRE-TESTING. NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324051 RUSCH GREENSPEC FO HANDLE SMALL LARYNGOSCOPE HANDLE CCW TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1