BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYMPHAZURIN 1% BLUE DYE

    MDR report key: 2971272 · Received April 18, 2007

    Report

    Report Number
    1219930-2007-00884
    Event Type
    Injury
    Date Received
    April 18, 2007
    Date of Event
    March 27, 2007
    Report Date
    April 5, 2007
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY, THE PT CALLED THAT SHE HAD REACTION TO THE PRODUCT AND THAT HER BLOOD PRESSURE DROPPED TO APPROXIMATELY 50/40 OR 40/50... SHE WAS NOT SURE. THE PT STATED SHE WAS ADMINISTERED A DOSAGE OF 5CC AND STATED SHE WAS TREATED WITH BENADRYL. NO OTHER INFORMATION WAS PROVIDED. PROCEDURE: UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYMPHAZURIN 1% BLUE DYE NONE GDW COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention