BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLASSVAN®

    MDR report key: 7375137 · Received March 27, 2018

    Report

    Report Number
    1058382-2018-00003
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Date of Event
    February 27, 2018
    Report Date
    March 27, 2018
    Manufacturer
    NIRAJ INDUSTRIES PVT LTD.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING SECTIONS REFERENCED BELOW WERE CORRECTED: THE 'DATE OF EVENT' WAS INADVERTENTLY RECORDED INCORRECTLY ON THE INITIAL REPORT OF THIS MDR. THE DATE WAS CHANGED FROM (B)(6) 2018 TO THE CORRECT DATE OF (B)(6) 2018 (AS REFLECTED IN THIS FOLLOW-UP REPORT). PROVIDING INFORMATION ABOUT THE 'OPERATOR OF DEVICE; PHYSICIAN SELECTED. THE INITIAL REPORTER OF THIS EVENT TO THE IMPORTER DID NOT PROVIDED WHETHER THEY REPORTED THIS EVENT BEING DISCUSSED TO THE FDA; THEREFORE, 'UNKNOWN' WAS SELECTED IN THIS SECTION. PROVIDING CLARIFICATION OF THE DATE THE 'REPORT SENT TO MANUFACTURER'; DATE CHANGED FROM 03/27/2018 TO THE CORRECT DATE OF 03/29/2018 (AS REFLECTED IN THIS FOLLOW-UP REPORT). THIS MDR WILL BE UPDATED AS PERTINENT INFORMATION IS RECEIVED ABOUT THIS EVENT.

    Description of Event or Problem · 1

    BLADE BROKE OFF IN PATIENT, WAS ABLE TO RECOVER.

    Description of Event or Problem · 1

    BLADE BROKE OFF IN PATIENT, WAS ABLE TO RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216305 GLASSVAN® BLADE GES NIRAJ INDUSTRIES PVT LTD. 2001T-10 160908AC

    Patients

    Seq Age Sex Outcome Treatment
    1