BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROG VALVE INLINE SIPHONGUARD

    MDR report key: 1971568 · Received January 24, 2011

    Report

    Report Number
    1226348-2011-00023
    Event Type
    Injury
    Date Received
    January 24, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC., MEDOS S.A.
    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

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS OT AVAILABLE FOR EVAL. WITHOUT THE DEVICE, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE THREE POSSIBLE LOT NUMBERS (CLLBG7, CLLDFP, AND CLMC05) HAVE BEEN PROVIDED, A REVIEW OF THE MFG RECORDS HAVE BEEN REVIEWED AND THEY REVEALED THAT ALL THREE DEVICES CONFIRMED TO ALL MFG AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO BEING RELEASED TO STOCK. IF AT SOME POINT THE DEVICE IS RETURNED FOR EVALUATION, THIS COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. BASED ON THIS EVAL, NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT INSUFFICIENT FLOW WAS FOUND DURING IMPLANTATION. AS A RESULT, THE DEVICE WAS FLUSHED USING A SYRINGE AND SUFFICIENT FLOW WAS CONFIRMED. IN ADDITION, AS A RESULT OF A BLOCKAGE, THE DEVICE WAS REVISED. IT WAS NOTED THAT TISSUE WAS FOUND IN THE REVISED VALVE.

    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., MEDOS S.A. NA CLLBG7

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention