BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREENSPEC FO HANDLE MEDIUM

    MDR report key: 2442266 · Received January 24, 2012

    Report

    Report Number
    3004365956-2012-00024
    Event Type
    Malfunction
    Date Received
    January 24, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 11, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    EQN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MFR AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: CUSTOMER CALLED SAYING AFTER HANDLES WERE STERILIZED, BATTERIES PUT IN, THEN HANDLE OVERHEATED AND WAS TOO HOT TO TOUCH. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH GREENSPEC FO HANDLE MEDIUM LARYNGOSCOPE HANDLE EQN TELEFLEX MEDICAL 113201

    Patients

    Seq Age Sex Outcome Treatment
    1