BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFESKIN PFE

    MDR report key: 564234 · Received December 12, 2004

    Report

    Report Number
    MW1034257
    Event Type
    Injury
    Date Received
    December 12, 2004
    Date of Event
    December 3, 2003
    Report Date
    December 12, 2004
    Manufacturer
    KIMBERLY-CLARK
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    3 PM EXPOSED TO PF LATEX EXAM GLOVES BY KIMBERLY-CLARK DURING SURGICAL FOLLOWUP EXAM. NURSE AND DR. HAD NOTED RECORDS AND CONTINUOUSLY HAD BEEN TOLD OF SEVERE ALLERGY TO LATEX. PT WAS PUT IN AN EXAM ROOM WHERE NRL GLOVES WERE PRESENT. PT EXITED ROOM AS SOON AS THEY REALIZED NRL GLOVES WERE THERE. DR MOVED PT TO ANOTER EXAM ROOM AND COMPLETED EXAM. PT STARTED EXPERIENCING SYMPTOMS OF ALLERGIC REACTION. SELF MEDICATED, AND PT ASKED DR. TO NOTE EXPOSURE IN CHART. HE STATED HE DOESN'T USE NRL ONLY NITRILE GLOVES THIS IS THE FIRST TIME PT HAS ENCOUNTERED NRL IN HIS OFFICE. PT WENT TO MEMBERS SERVICE IN SAME BUILDING TO REPORT EXPOSURE. PT THEN STARTED HAVING CHEST PRESSURE, THE SECRETARY CALLED A CODE 1. PT WAS TAKEN TO ER BY WHEELCHAIR. PT WAS TREATED FOR ANAPHYLACTIC ALLERGIC REACTION TO LATEX WITH EPINEPHRINE, ZANTAC, AND BENADRYL. NO STEROIDS BECAUSE PT HAD JUST COMPLETED LONG TERM DOSAGE. PT LEFT ER FOR HOME 6 HOURS LATER 9 PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFESKIN PFE EXAM GLOVES LYY KIMBERLY-CLARK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R