BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROYALMED (T.B.C. PRODUCTS)

    MDR report key: 211654 · Received February 25, 1999

    Report

    Report Number
    2126208-1999-00004
    Event Type
    Injury
    Date Received
    February 25, 1999
    Date of Event
    February 17, 1999
    Report Date
    February 25, 1999
    Manufacturer
    EVERGRADE HEALTHCARE PRODUCTS SDN. BHD.
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN EMPLOYEE EXPERIENCED SEVERE ALLERGIC REACTIONS AFTER PUTTING ON POWDER-FREE LATEX GLOVES. SHE SUFFERED WATERY, SWOLLEN EYES AND SHORTNESS OF BREATH. THE INITIAL REPORTER OF THIS EVENT FELT THAT THERE WAS POWDER IN THE GLOVES. THE EMPLOYEE LEFT WORK TO GO TO THE DOCTOR. THE FACILITY WAS LATER FAXED A REPORT STATING THAT BENADRYL HAD BEEN PRESCRIBED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROYALMED (T.B.C. PRODUCTS) POWDER-FREE LATEX GLOVES LYY EVERGRADE HEALTHCARE PRODUCTS SDN. BHD. 20121300 *

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention