BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 20036555 · Received August 22, 2024

    Report

    Report Number
    2411236-2024-00014
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    April 1, 2024
    Report Date
    August 21, 2024
    Manufacturer
    HARTALEGA NGC SDN. BHD.
    Product Code
    LZA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A 53-YEAR-OLD FEMALE DOCTOR HAS BEEN PERFORMING RESTORATIVE DENTAL PROCEDURES SINCE APRIL OF THIS YEAR WHILE USING THESE GLOVES. THEY'VE BEEN EXPERIENCING SYMPTOMS SUCH AS ITCHING, BURNING, SWELLING AND HAVE BEEN SCRATCHING THEIR HANDS DUE TO THEM FEELING OVERHEATED. THEY HAD AN APPOINTMENT SCHEDULED WITH THEIR DERMATOLOGIST THE WEEK STARTING (B)(6) 2024 AS A REFERRAL WAS SENT BY THEIR PRIMARY CARE PHYSICIAN. THEY HAVE HAD TO COVER THEIR HANDS WITH COTTON MATERIAL BEFORE USING THE GLOVES. IN THE INTERIM, THEY HAVE ALSO BEEN USING A PRESCRIPTION OINTMENT TO RELIEVE THEIR ITCHING AND SWELLING. THE DOCTOR IS THE ONLY ONE USING THE GLOVES AT THE OFFICE. THE PRODUCT IS STORED IN THEIR CABINET. THIS IS THE FIRST TIME THIS HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29809 HENRY SCHEIN CRITERION NITRILE N300 GLOVES MEDIUM LZA HARTALEGA NGC SDN. BHD.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Other