BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NON STERILE ULTRA CARE NATURAL RUBBER LATEX EXAMINATION

    MDR report key: 148218 · Received February 11, 1998

    Report

    Report Number
    1221893-1998-00001
    Event Type
    Injury
    Date Received
    February 11, 1998
    Date of Event
    December 22, 1997
    Report Date
    February 10, 1998
    Manufacturer
    TILLOTSON HEALTHCARE CORP.
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RN WORE GLOVES FOR FIRST TIME FOR APPROXIMATELY 20 MINUTES AND WAS FINE. RN AND REPORTER NOTICED RESIDUE ON HANDS AFTER REMOVING GLOVES. RN HAD EYE IRRITATION CAUSING ITCH WITHIN 10-20 MINUTES OF GLOVE REMOVAL. TOUCHED FACE; LIPS SWELLED, EYES ITCHED, EXPERIENCED HIVES ON FACE ONLY, AND STARTED SNEEZING. RN CANNOT REMEMBER WASHING HANDS BEFORE TOUCHING FACE. WENT TO ER AND WAS GIVEN PREDNISONE, EYE DROPS AND BENADRYL. CONTINUED WITH PREDNISONE AND HAD "EYE GRITS" FOR 4 DAYS AFTER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON STERILE ULTRA CARE NATURAL RUBBER LATEX EXAMINATION MEDICAL EXAMINATION GLOVE LYY TILLOTSON HEALTHCARE CORP. NA R6A04117

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening| R