BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AHMED GLAUCOMA VALVE

    MDR report key: 3853483 · Received May 29, 2014

    Report

    Report Number
    1000125279-2014-00002
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 29, 2014
    Manufacturer
    NEW WORLD MEDICAL, INC.
    Product Code
    KYF
    PMA / PMN Number
    K925636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE AWAITING FURTHER INFORMATION FROM THE DOCTOR. THE RESULTS OF THE INVESTIGATION ARE PENDING. THE EXPLANTED VALVE WAS REPLACED. THE PATIENT IS DOING FINE WITH NO REPORTED COMPLICATIONS.

    Description of Event or Problem · 1

    DOCTOR HAD VALVES SITTING ON THE SHELF IN AN OUT OF (B)(6) FOR YEARS. HE IMPLANTED ON E (FP7 W/PC CLIP) THAT EXPIRES IN 2015 IN A NEOVASCULAR GLAUCOMA PATIENT. THE VALVE WAS PRIMED BUT WAS HARD TO PRIME. IOP WAS IN 40'S 2 WEEKS AFTER SURGERY. THE VALVE WAS EXPLANTED THE WEEK OF (B)(6). WE ARE AWAITING THE RETURN OF THE EXPLANTED VALVE. THE EXPLANTED VALVE WAS REPLACED BY AN AHMED GLAUCOMA VALVE FP7. THE PATIENT IS DOING WELL AFTER THE REPLACEMENT SURGERY WITH NO REPORTED COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315674 AHMED GLAUCOMA VALVE GLAUCOMA SHUNT KYF NEW WORLD MEDICAL, INC. PC7 NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention