BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREENSPEC STUBBY HANDLE

    MDR report key: 2901493 · Received January 3, 2013

    Report

    Report Number
    1044475-2013-00003
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 8, 2012
    Report Date
    December 10, 2012
    Manufacturer
    TELEFLEX
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    COMPLAINT IS REPORTED AS: WHEN BATTERIES ARE INSTALLED INTO THE HANDLE THE UNIT BEGINS TO OVERHEAT. NO PATIENT INVOLVEMENT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2812 RUSCH GREENSPEC STUBBY HANDLE GREENSPEC STUBBY HANDLE CCW TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1