BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIAMOND GRIP PLUS

    MDR report key: 225886 · Received June 8, 1999

    Report

    Report Number
    2939513-1999-00001
    Event Type
    Other
    Date Received
    June 8, 1999
    Date of Event
    May 19, 1999
    Report Date
    May 27, 1999
    Manufacturer
    OMNIGRACE (THAILAND) LTD
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 5/27/99 THE INITIAL REPORTER, CORPORATE SAFETY OFFICER, INDICATED THE FOLLOWING: INDIVIDUAL, PHLEBOTOMIST, WORKING IN THE BLOOD DRAWING AREA, NOTICED THAT UPON REMOVAL OF THE LATEX GLOVES HIS HANDS BECAME VERY RED, FOLLOWED BY HIS EYES BEGINNING TO SWELL AND HE BEGAN TO EXPERIENCE DIFFICULTY BREATHING. THE INDIVIDUAL WAS TRANSPORTED TO A LOCAL ER FACILITY WHERE HE WAS GIVEN BENADRYL. HE REMAINED AT THE ER FACILITY FOR SEVERAL HOURS UNDER OBSERVATION, AND ONCE HE WAS CONSIDERED TO BE STABLE HE WAS GIVEN A SECOND DOSE OF BENADRYL AND ALLOWED TO GO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMOND GRIP PLUS LATEX EXAMINATION GLOVE LYY OMNIGRACE (THAILAND) LTD DGP-350 811025418

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other