BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROG VALVE INLINE SIPHONGUARD

    MDR report key: 996916 · Received February 12, 2008

    Report

    Report Number
    1226348-2008-00031
    Event Type
    Injury
    Date Received
    February 12, 2008
    Date of Event
    January 17, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC./MECOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K992173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CODMAN HAS REQUESTED THE VALVE BE RETURNED FOR EVAL. UPON COMPLETION OF THE INVESTIGATION, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    SALES REP REPORTS PT HAD SURGERY FOR SHUNT PLACEMENT 7 YRS AGO AND HAD IMPROVEMENT BUT POSSIBLE "LOW PRESSURE" HEADACHES PER THE SURGEON. IN 2008, PT HAD SHUNT REVISION. WHILE ATTEMPTING TO DISCONNECT VALVE FROM DISTAL CATHETER THE SHUNT SILICONE HOUSING BROKE AND SIPHONGUARD CAME OUT OF HOUSING. SHUNT WAS REPLACED WITH CHPV.

    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./MECOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention