BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA-CARE LATEX GLOVE

    MDR report key: 86791 · Received April 28, 1997

    Report

    Report Number
    MW1011220
    Event Type
    Injury
    Date Received
    April 28, 1997
    Date of Event
    April 25, 1997
    Report Date
    April 28, 1997
    Manufacturer
    TILLOTSON HEALTHCARE CORP.
    Product Code
    LYY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    USER IN OR WITH OTHERS USING NON-STERILE GLOVES, ASSUMING THEY WERE POWDER-FREE. USER'S EXPOSED AREAS BECAME RED, HOT, ITCHY, AND BURNING. USER'S EYE LIDS SWELLED AND BECAME PAINFUL AND THE USER ALSO HAD A SORE THROAT. HIVES ON THE FACE WERE ALSO EXPERIENCED. USER CALLED THE 1-800 ON THE GLOVE BOX AND THE MFR CLAIMED THAT THERE WAS POWDER ON THE GLOVE. THE BOX LABELING CLEARLY STATED THERE WAS NO DONNING POWDER. A SECOND BOX (SAME TYPE) STATED POWDER FREE POLYMER INTERIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-CARE LATEX GLOVE LATEX GLOVE LYY TILLOTSON HEALTHCARE CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR