BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREEN RUSCHLIE DISP MTL MILL 4

    MDR report key: 4617404 · Received March 18, 2015

    Report

    Report Number
    1044475-2015-00118
    Event Type
    Malfunction
    Date Received
    March 18, 2015
    Date of Event
    February 19, 2015
    Report Date
    February 19, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(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 CLEAR PLASTIC PIECE ON THE END OF THE GRL WAS CRACKED AND CAME APART DURING THE PROCESS OF INTUBATION. NO PATIENT ISSUES REPORTED. NO INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185195 RUSCH GREEN RUSCHLIE DISP MTL MILL 4 CCW TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1