BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRICUT® STRAIGHT SHAFT 4MM 11CM LONG

    MDR report key: 7142538 · Received December 22, 2017

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    Report

    Report Number
    1045254-2017-00485
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    November 28, 2017
    Report Date
    December 22, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    UDI-DI
    20681490047450
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE BLADE BROKE AS SOON AS IT WAS TURNED ON. IT WAS NEVER USED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923101 TRICUT® STRAIGHT SHAFT 4MM 11CM LONG BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884004 0214148516 20681490047450

    Patients

    Seq Age Sex Outcome Treatment
    1