BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 1901897 · Received November 12, 2010

    Report

    Report Number
    3003701944-2010-00029
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 13, 2010
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED, THE PRODUCT MET RELEASE CRITERIA. THERE HAS BEEN ONE OTHER COMPLAINT REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 10/28/2010, 11/03/2010, AND 11/08/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A MATERIALS MANAGER REPORTED "THE POSITIONING WAS OFF" ON A GLAUCOMA SHUNT. IN A FOLLOW UP PHONE CALL WITH THE MATERIALS MANAGER, SHE REPORTED THE SURGEON WAS NOT ABLE TO COMPLETE THE PROCEDURE BECAUSE THERE WAS NO BACK UP SHUNT AVAILABLE. SHE DID NOT KNOW IF THE PROCEDURE WAS CONVERTED TO A TRADITIONAL TRABECULECTOMY OR IF ANOTHER SHUNT WAS PLACED AT A LATER DATE. PATIENT IMPACT REMAINS UNKNOWN. ADDITIONAL INFORMATION 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 101405

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention