BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOSERT UVC INSERTION TRAY

    MDR report key: 216837 · Received April 1, 1999

    Report

    Report Number
    1314412-1999-00010
    Event Type
    Injury
    Date Received
    April 1, 1999
    Report Date
    March 5, 1999
    Manufacturer
    SHERWOOD DAVIS AND GECK
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS, A DR WAS ATTEMPTING TO PLACE A UVC IN A BABY, WHEN THE HEMOSTATS SHREDDED THE BABIES UMBILICUS. THEY WERE ABLE TO SALVAGE THE PROCEDURE BY USING OTHER HEMOSTATS AVAILABLE ON THE FLOOR. THE DR REPORTED THE HEMOSTATS WERE IN A KIT MARKED "NEW AND IMPROVED". HE STATED, HE HAD TO USE TWO HANDS JUST TO GET THEM OPEN. AND THEN THEY INJURED THE UMBILICUS. THE BABY IS REPORTED TO BE STABLE. AGE OF PT IS 34 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOSERT UVC INSERTION TRAY UVC INSERTION KIT DQO SHERWOOD DAVIS AND GECK NA 985570

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention