BEUDAMED
    FDA Adverse Event Summary report: N

    COLLODION 11

    MDR report key: 2613797 · Received June 8, 2012

    Report

    Report Number
    2613797
    Date Received
    June 8, 2012
    Date of Event
    May 31, 2012
    Report Date
    June 8, 2012
    Manufacturer
    MAVIDON
    Product Code
    IAW
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT HAD A 24-HOUR EEG LEADS PLACED USING COLLODION AND WAS SENT HOME. THE PATIENT BEGAN TO FEEL VERY HOT, SWEATING, ITCHING AND WITH RED COLOR SPOTS ON HER HEAD. SHE WAS SEND TO THE ED (EMERGENCY DEPARTMENT). IN THE ED, THE PATIENT WAS NOTED HAVING AN ALLERGIC REACTION WITH SHORTNESS OF BREATH, THROAT SWELLING, HIVES, DIZZINESS, TACHYCARDIA, AND EXPIRATORY WHEEZES. OXYGEN WAS APPLIED; ALBUTEROL VIA NEBULIZER AND EPINEPHRINE SUBCUTANEOUS WAS ADMINISTERED. THE PATIENT'S HEAD WAS SHAVED TO REMOVE ALL TRACES OF GLUE BELIEVED TO BE CAUSING THE REACTION. PATIENT WAS STABILIZED AND DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLODION 11 COLLODION 11, ETHER FREE IAW MAVIDON * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR