BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIPHONGUARD, CSF FLD CONTRL DV

    MDR report key: 1652768 · Received April 6, 2010

    Report

    Report Number
    1226348-2010-00103
    Event Type
    Injury
    Date Received
    April 6, 2010
    Date of Event
    February 15, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    992173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED AFTER EXPLORATION OF THE DEVICE RESULTING FROM ADVERSE PT SYMPTOMS, IT WAS FOUND THAT THE ANTI SIPHON DEVICE WAS TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIPHONGUARD, CSF FLD CONTRL DV SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention