BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN INC.

    MDR report key: 8552255 · Received April 25, 2019

    Report

    Report Number
    2411236-2019-00003
    Event Type
    Injury
    Date Received
    April 25, 2019
    Date of Event
    April 3, 2019
    Report Date
    April 3, 2019
    Manufacturer
    KOSSAN LATEX INDUSTRIES (M) SDN BHD
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    A FEMALE DENTAL ASSISTANT WAS WEARING LATEX GLOVES WHEN SHE STARTED HAVING DIFFICULTY BREATHING AND HER THROAT STARTED TO FEEL AS IF IT WAS SWELLING. THE ASSISTANT STATED SHE BELIEVES SHE HAS AN ALLERGY TO RUBBER, ELASTIC AND LATEX FROM YEARS OF WEARING THESE MATERIALS. THE ASSISTANT DID NOT SEEK ANY MEDICAL ATTENTION AND WAS NOT PRESCRIBED ANY MEDICATION, NOR DID SHE TAKE ANY OTC MEDICATIONS TO TREAT THE REACTION. THE SWELLING WAS REPORTED TO SUBSIDE ON ITS OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342691 HENRY SCHEIN INC. LATEX PATIENT EXAMINATION GLOVE LYY KOSSAN LATEX INDUSTRIES (M) SDN BHD K10048407

    Patients

    Seq Age Sex Outcome Treatment
    1 Other