BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 3843591 · Received March 25, 2014

    Report

    Report Number
    3003701944-2014-00039
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    February 25, 2014
    Report Date
    February 26, 2014
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS. 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. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS TO GATHER ADD'L INFO HAVE BEEN UNSUCCESSFUL. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING A GLAUCOMA FILTERING SHUNT PROCEDURE THE SHUNT WOULD NOT RELEASE FROM THE DELIVERY SYSTEM. THE SURGERY WAS COMPLETED WITH A TRABECULECTOMY PROCEDURE. THERE WAS NO HARM TO THE PT. ADD'L INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174003 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL 132702

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK