BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLASSVAN®

    MDR report key: 7241951 · Received February 5, 2018

    Report

    Report Number
    8040409-2018-00001
    Event Type
    Malfunction
    Date Received
    February 5, 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
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 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
    86636 GLASSVAN® BLADE GES NIRAJ INDUSTRIES PVT LTD. 2001T-15 171008AC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown