BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH EQUIPLITE MTL. DISP. MACINTOSCH BLADE, 2

    MDR report key: 3020713 · Received March 18, 2013

    Report

    Report Number
    1044475-2013-00039
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 25, 2013
    Manufacturer
    TELEFLEX
    Product Code
    CAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED BY THE MANUFACTURER, BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE LARYNGOSCOPE BLADE IS NOT MAKING A SOLID CONNECTION WITH THE HANDLE AND IT WAS NOT SEATING PROPERLY ON THE HANDLE. THE BLADE WAS LOOSE AND WOULD NOT STAY SEATED. THE ALLEGED ISSUE DETECTED DURING TESTING. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111738 RUSCH EQUIPLITE MTL. DISP. MACINTOSCH BLADE, 2 LARYNGOSCOPE BLADE CAL TELEFLEX 1210722

    Patients

    Seq Age Sex Outcome Treatment
    1