BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 2915075 · Received December 20, 2012

    Report

    Report Number
    3003701944-2012-00090
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, NO ABNORMALITIES WERE FOUND, AND THE PRODUCT MET RELEASE CRITERIA. THE SHUNT'S INNER LUMEN WAS FOUND TO BE PARTIALLY BLOCKED. THE COMPLAINANT STATEMENT "NO FLOW" WAS CONFIRMED. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT A SHUNT WAS REMOVED DURING SURGERY, AS NO AQUEOUS HUMOR WAS RELEASED AFTER INSERTION. ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL, WHO INDICATED THE SHUNT WAS EXCHANGED FOR A NEW ONE DURING THE SAME SURGICAL PROCEDURE. THERE WAS NO IMPACT TO THE PT POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50PL 122512

    Patients

    Seq Age Sex Outcome Treatment
    1