BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROG VALVE INLINE SIPHONGUARD

    MDR report key: 1161275 · Received September 15, 2008

    Report

    Report Number
    1226348-2008-00237
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HISTORICALLY FOR COMPLAINTS OF THIS NATURE, VISUAL EXAMINATIONS OF THE RETURNED VALVES HAVE FOUND CUTS OR TEARS IN THE SILICONE HOUSING CAUSED BY CONTACT WITH SHARP INSTRUMENTS DURING A SURGICAL PROCEDURE OR BENDING OF THE SILICONE HOUSING DURING AN IMPLANT OR EX-PLANT PROCEDURE. REVIEWS OF THE DEVICE HISTORY RECORDS HAVE FOUND NO DISCREPANCIES. THE INSTRUCTIONS FOR USE, WHICH ACCOMPANY THE VALVES CAUTION THAT CARE SHOULD BE TAKEN IN HANDLING THE VALVES AS SILICONE HAS A LOW CUT AND TEAR RESISTANCE. A CORRECTION ACTION WAS PUT IN PLACE BY DEVELOPING A NEW MOLD HOUSING, WHICH WAS DESIGNED TO ADD A THICKER WALL RESISTANCE. BY CREATING THE MOLD HOUSING IT SHOULD HELP TO REDUCE PROPAGATION OF SMALL CUTS AND TEARS. A FOLLOW UP REPORT WILL BE FILED IF THE INVESTIGATION OF THIS DEVICE REVEALS A RESULT DIFFERENT FROM THAT WHICH IS STATED ABOVE OR IF ANY FURTHER INFO REGARDING THE CAUSE OR MODE OF FAILURE IS MADE AVAILABLE. OTHERWISE, THE COMPLAINT IS CONSIDERED CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT: "VALVE HAD TO BE EXPLANTED DUE TO CUT OR CRACK IN THE VALVE'S HOUSING".

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR