BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 2172647 · Received June 24, 2011

    Report

    Report Number
    3003701944-2011-00019
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Report Date
    May 11, 2011
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO A SHUNT NOT RELEASING WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO OPTONOL'S ACCEPTANCE CRITERIA. 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 VIA MAIL ON (B)(4) 2011. AT THIS TIME ADD'L INFO HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED, THE SHUNT WOULD NOT RELEASE. PT IMPACT REMAINS UNK. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL 103910

    Patients

    Seq Age Sex Outcome Treatment
    1 NI