BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISITEC

    MDR report key: 2780923 · Received September 26, 2012

    Report

    Report Number
    2780923
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    August 23, 2012
    Report Date
    September 10, 2012
    Manufacturer
    BEAVER VISITEC
    Product Code
    HMX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FRONTALIS SUSPENSION SET WAS PUT IN PLACE IN PATIENT'S LEFT EYELID. ONE DAY LATER, DURING FOLLOW UP, DOCTOR NOTED THE SLING HAD FAILED AND PATIENT WAS SCHEDULED FOR AN ADDITIONAL PROCEDURE TO REPLACE THE IMPLANT. ONE WEEK LATER, THE PATIENT HAD THE SECOND PROCEDURE USING A DIFFERENT IMPLANT. WHEN THE ORIGINAL IMPLANT WAS REMOVED, IT WAS NOTED TO BE BROKEN IN HALF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISITEC CANNULA, OPHTHALMIC HMX BEAVER VISITEC * 3029566

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO