BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXCEL 23KHZ CEM NOSECONE BOX6

    MDR report key: 1565483 · Received December 16, 2009

    Report

    Report Number
    2648988-2009-00051
    Event Type
    Other
    Date Received
    December 16, 2009
    Date of Event
    November 2, 2009
    Report Date
    December 15, 2009
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    EFB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE BUTTON ON TOP OF THE NOSECONE REMAINED DEPRESSED WHEN IT WAS PRESSED. THE PT RECEIVED A DIATHEMY BURN. INTEGRA HAS REQUESTED ADD'L INFO FROM THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCEL 23KHZ CEM NOSECONE BOX6 ULTRASONIC SURGICAL PRODUCTS EFB INTEGRA NEUROSCIENCES PR 0000001084683

    Patients

    Seq Age Sex Outcome Treatment
    1 Other