BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRACARE

    MDR report key: 157752 · Received March 19, 1998

    Report

    Report Number
    MW1013221
    Event Type
    Other
    Date Received
    March 19, 1998
    Date of Event
    January 1, 1997
    Report Date
    March 19, 1998
    Manufacturer
    TILLOTSON HEALTHCARE CORP.
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE RPTR, SHE BEGAN EXPERIENCING SYMPTOMS IN 1997. THE RPTR HAD SLOUGHING OF THE SKIN ON HER LIPS. APPROX ONE MO AGO, THE RPTR TOUCHED HER EYE AFTER WEARING LATEX EXAM GLOVES. AS A RESULT, SHE IMMEDIATELY EXPERIENCED SWELLING/PRESSURE IN THE PERIORBITAL AREA AS WELL AS "BLISTER LIKE" SKIN ON ONE EYE LID. THIS REACTION WAS HER FIRST. SHE NOW HAS HAD A TOTAL OF 3 REACTIONS. THE RPTR ALSO FEELS HER ASTHMA HAS BEEN EXACERBATED BY THE LATEX ALLERGY. SHE WAS HOSPITALIZED RECENTLY FOR 4 DAYS DUE TO HER ASTHMA AND BRONCHITIS. THE ONLY OTHER SYMPTOM REPORTED WAS ITCHY ARMS WHEN HER SURGICAL GLOVES CONTACT HER ARM. THE RPTR HAS BEEN IN THE HEALTH CARE PROFESSION FOR 28 YRS AS A DENTAL ASSISTANT AND AN RN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACARE LATEX EXAM GLOVES LYY TILLOTSON HEALTHCARE CORP. NA R2B15127

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other