BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENVER SHUNT

    MDR report key: 2978466 · Received February 19, 2013

    Report

    Report Number
    MW5029075
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 19, 2013
    Manufacturer
    CAREFUSION CORPORATION/DRAINAGE
    Product Code
    KPM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS THE SECOND TIME SHE HAS COME IN WITH PLUG BLOCKING HER DENVER SHUNT IN LESS THAN 2 WEEKS. BOTH TIMES IT HAS CLEARED EASILY. WE ARE ACTIVELY WORKING WITH CAREFUSION AND SENT THEM BLINDED IMAGES TO PREVENT A REOCCURRENCE. CONTACT NAME - (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72453 DENVER SHUNT DENVER SHUNT KPM CAREFUSION CORPORATION/DRAINAGE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention