BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 15964 · Received July 18, 1994

    Report

    Report Number
    15964
    Event Type
    Injury
    Date Received
    July 18, 1994
    Date of Event
    April 18, 1994
    Report Date
    April 21, 1994
    Manufacturer
    UNKNOWN
    Product Code
    LID
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAVING INCREASING NUMBER OF HEADACHES. TESTS REVEALED UP SHUNT NOT WORKING AND SEVERE HYDROCEPHALUS. DEVICE REMOVED IN OR ON 4/18/94. A SMALL PLASTIC TUBE APPEARS TO HAVE BROKEN LOOSE FROM THE SHUNT. DEVICE WAS APPARENTLY IMPLANTED IN A HOSPITAL IN COLUMBUS, OHIO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN Implant VENTRICULOPERITONEAL SHUNT LID UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 29 * Hospitalization| O| R