BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLASSVAN®

    MDR report key: 7209865 · Received January 22, 2018

    Report

    Report Number
    1058382-2018-00001
    Event Type
    Malfunction
    Date Received
    January 22, 2018
    Date of Event
    December 20, 2017
    Report Date
    January 22, 2018
    Manufacturer
    NIRAJ INDUSTRIES PVT LTD.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BLADES HAVE BEEN BREAKING, AND IN SOME CASES, BREAKING INSIDE THE PATIENT WHILE BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52714 GLASSVAN® BLADE GES NIRAJ INDUSTRIES PVT LTD. 2001T-15 171008AC

    Patients

    Seq Age Sex Outcome Treatment
    1