BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED EX

    MDR report key: 86584 · Received February 9, 1995

    Report

    Report Number
    86584
    Event Type
    Injury
    Date Received
    February 9, 1995
    Date of Event
    August 18, 1994
    Report Date
    September 7, 1994
    Manufacturer
    MED EX
    Product Code
    FMG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 8/18, LYMPHOCELE SCLEROSED WITH BETADINE AT 0800. TUBE TO BE UNCLAMPED 1 HR. AFTER INSERTION. DOCUMENTATION BY NURSE AT 1115 THAT TUBE WAS OPENED. PT DISCHARGE AT 1700. ON 8/20 PT RETURNED TO X-RAY DEPT WITH LEAKING AROUND TUBE. STOPCOCK WAS IN OFF POSITION PREVENTING ANY DRAINAGE. FLUID WAS ASPIRATED AND TUBE REATTACHED TO BAG. PT HAS BEEN SEEN ON 3 ADD'L OCCASIONS TO CHECK ON RESOLUTION OF LYMPHOCELE. TUBE WAS ORIGINALLY PLACED 8/10/94 STOP COCK IS ADDED TO THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED EX STOPCOCK FMG MED EX * *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R SENKOT| CLINDAMYCIN| MEVACOR| KCL| PROCARDIA| DOSS| LASIX| TAPROL| DARVON| DALMON