BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIONICS

    MDR report key: 213749 · Received March 8, 1999

    Report

    Report Number
    1219140-1999-00002
    Event Type
    Injury
    Date Received
    March 8, 1999
    Date of Event
    September 14, 1998
    Report Date
    March 4, 1999
    Manufacturer
    RADIONICS, INC.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE PT, ONE MONTH AFTER THE USE OF RADIONICS MEDIUM PRESSURE SYSTEM, HAS DEVELOPED SUBDURAL BILATERAL HEMATOMA. RADIONICS CONTOUR-FLEX INSTRUCTIONS FOR USE REFERENCES THESE POSSIBLE COMPLICATIONS. REPORTED 01/25/1999 TO RADIONICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIONICS Implant CONTOUR-FLEX SHUNT, REGULAR, MEDIUM JXG RADIONICS, INC. 11855 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R