BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AHMED GLAUCOMA VALVE

    MDR report key: 3178082 · Received May 20, 2013

    Report

    Report Number
    1000125279-2013-00001
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    March 5, 2013
    Report Date
    May 20, 2013
    Manufacturer
    NEW WORLD MEDICAL, INC.
    Product Code
    KYF
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, WE RECEIVED A LETTER FROM FDA CONTAINING A REPORTED MALFUNCTION OF THE AHMED VALVE. ON (B)(4), WE TRY TO CONTACTED MS. (B)(6). SHE RETURNED THE CALL ON (B)(6), ASKING TO E-MAIL HER ON REFERENCE TO THIS REPORT. I ALSO ASKED HER IF THE PRODUCT WAS USED TO TREAT THE PT AND IF IT WILL BE RETURNED TO NEW WORLD MEDICAL, INC. WE GOT HER ANSWER THE NEXT DAY INDICATING THAT THE PRODUCT WAS NOT USED ON THE PT AND THE PLAN IS TO RETURN THE DEVICE. AS OF TODAY, (B)(4) 2013, PRODUCT HAS NOT BEEN RETURNED TO NEW WORLD MEDICAL, INC. FOR EVAL. PRIOR TO RELEASE TO MARKET ALL DOCUMENTS INDICATED THE PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR DISTRIBUTION.

    Description of Event or Problem · 1

    FILE: XXXXXX. EVENT DESC: THE VALVE IS ALWAYS PRIMED BY SURGEON, PRIOR TO INSERTION. THE SURGEON WAS UNABLE TO PRIME THE VALVE. A NEW AHMED VALVE WAS OBTAINED AND WORKED PROPERLY. WHAT WAS THE ORIGINAL PROCEDURE: AHMED VALVE PLACEMENT LEFT EYE. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223049 AHMED GLAUCOMA VALVE GLAUCOMA SHUNT KYF NEW WORLD MEDICAL, INC. FP7 L0111

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR NONE INDICATED