BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROG VALVE INLINE SIPHONGUARD

    MDR report key: 1790060 · Received August 6, 2010

    Report

    Report Number
    1226348-2010-00247
    Event Type
    Injury
    Date Received
    August 6, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    K992173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION AND EXAMINATION OF THE DEVICE, IT WAS NOTED THAT THIS COMPLAINT HAS BEEN CONFIRMED. IT WAS DETERMINED THAT BIOLOGICAL DEBRIS WITHIN THE DEVICE LIKELY CAUSED THE DIFFICULTY EXPERIENCED BY THE CUSTOMER. THIS BIOLOGICAL DEBRIS WAS THE LIKELY ROOT CAUSE OF THE PRESSURE TEST FAILURE. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE VALVE MET SPECIFICATIONS WHEN RELEASED TO STOCK. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT IT WAS FOUND THAT THE VENTRICLES OF THE PT'S BRAIN BECAME TOO LARGE. AS A RESULT THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM PROG VALVE INLINE SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. NA CFKCNZ

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention