BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN EXTERNAL DRAINAGE SYSTEM III

    MDR report key: 1730290 · Received June 18, 2010

    Report

    Report Number
    1226348-2010-00197
    Event Type
    Injury
    Date Received
    June 18, 2010
    Date of Event
    May 24, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC. MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K954021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT A CRACK WAS FOUND ON THE PROXIMAL LUNER LOCK AREA. ADDITIONALLY, DURING THE PROCEDURE OF CONNECTING THE ICP, AIR BUBBLES WAS ALSO FOUND IN THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN EXTERNAL DRAINAGE SYSTEM III SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. MEDOS S.A. NA CLFBB8

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention