BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 3810792 · Received March 21, 2014

    Report

    Report Number
    3003701944-2014-00031
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 20, 2014
    Report Date
    February 20, 2014
    Manufacturer
    OPTONOL LTD.
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REC'D BY A COMPANY REP AND IS IN TRANSIT TO THE MFG SITE FOR INVESTIGATION. INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. ADD'L INFO WAS REQUESTED AND REC'D. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THREE FILTRATION DEVICES HAD TO BE REMOVED DURING SURGERY BECAUSE THEY WERE NOT DRAINING. A FOURTH DEVICE WAS IMPLANTED ON THE PT DURING THE SAME SURGERY. ADD'L INFO WAS REQUESTED AND REC'D. THIS IS ONE OF THREE MEDICAL DEVICE REPORTS BEING FILED FOR THIS EVENT. THIS REPORT IS FOR THE FIRST DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169831 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL LTD. UNK 132009

    Patients

    Seq Age Sex Outcome Treatment
    1