BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 3142998 · Received May 30, 2013

    Report

    Report Number
    3003701944-2013-00041
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    January 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO SAMPLE WAS RETURNED, THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED AND VISUAL INSPECTION CANNOT BE PERFORMED. BECAUSE A SAMPLE WAS NOT RETURNED, THE ROOT CAUSE CANNOT BE DETERMINED AND NO ACTIONS ARE TAKEN. BECAUSE A SAMPLE WAS NOT RETURNED, THE ROOT CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY RECORD (DHR) FOR THE BATCH WAS REVIEWED. NO ABNORMALITIES WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO RELEASE CRITERIA. THE ROOT CAUSE CANNOT BE DETERMINED. NO OTHER COMPLAINTS REPORTED IN THE LOT. ADD'L INFO WAS REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGICAL COORDINATOR REPORTED THAT AFTER A GLAUCOMA FILTRATION DEVICE IMPLANTATION, THAT THE DEVICE WAS NOT FUNCTIONING AS EXPECTED. THE GLAUCOMA FILTRATION DEVICE WAS EXPLANTED. ADD'L INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239684 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL 113108

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention