BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM INLINE PROGRAMMABLE VALVE SG

    MDR report key: 1161278 · Received September 15, 2008

    Report

    Report Number
    1226348-2008-00240
    Event Type
    Injury
    Date Received
    September 15, 2008
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THIS COMPLAINT HAS BEEN CONFIRMED. THE SILICONE HOUSING WAS TORN AND THE SIPHON GUARD WAS SEPARATED FROM THE VALVE. THE CAUSE(S) OF THE SILICONE HOUSING DAMAGE COULD NOT BE DETERMINED. HOWEVER, IT SHOULD BE NOTED THAT ALL VALVES ARE TESTED FOR LEAKAGE DURING THE MFG PROCESS AND NO LEAKAGE WAS VERIFIED FOR THIS VALVE. A NEW MOLD WAS IMPLEMENTED DURING OCTOBER 2007. A WALL THICKNESS WAS ADDED IN THE STRESSED SECTION OF THE HOUSING, WHICH SHOULD REDUCE THE LIKELIHOOD OF PROPAGATION OF ANY SMALL DAMAGES TO THE SILICONE MATERIAL. THIS VALVE WAS MFG BEFORE THIS NEW MOLD IMPLEMENTATION. A REVIEW OF THE DEVICE HISTORY RECORDS WAS CONDUCTED AND THEY VERIFIED THAT THIS VALVE CONFORMED TO THE REQUIRED SPECIFICATIONS WHEN RELEASED TO STOCK. BASED ON THE RESULTS OF THIS INVESTIGATION, 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

    CUSTOMER REPORTS THAT: "SIPHONGUARD BROKE AWAY FROM VALVE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM INLINE PROGRAMMABLE VALVE SG SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC./MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention