BEUDAMED
    FDA Adverse Event Other Summary report: N

    EDM VENTRICULAR DRAINAGE KIT

    MDR report key: 33413 · Received June 13, 1996

    Report

    Report Number
    MW1009294
    Event Type
    Other
    Date Received
    June 13, 1996
    Date of Event
    May 18, 1996
    Report Date
    June 6, 1996
    Manufacturer
    PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
    Product Code
    HCA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BREAK IN CLOSED, STERILE CSF EXTERNAL DRAINAGE AND MONITORING (EDM) SYSTEM WAS APPARENT WHEN NURSE WAS EMPTYING FROM ONE RESERVOIR TO ANOTHER (RESERVOIR #1 TO #2), AND FLUID WAS OBSERVED LEAKING FROM RESERVOIR #1. THE EDM WAS NOT PATENT. A COMPLETE STERILE CHANGE OF SYSTEM WAS PERFORMED BY PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDM VENTRICULAR DRAINAGE KIT CSF EXTERNAL DRAINAGE AND MONITORING SYSTEM HCA PUDENZ-SCHULTE MEDICAL RESEARCH CORP. J2087

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other