BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTIVIRAL FACEMASK

    MDR report key: 6551280 · Received May 8, 2017

    Report

    Report Number
    1417592-2017-00028
    Event Type
    Injury
    Date Received
    May 8, 2017
    Report Date
    May 8, 2017
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    OUK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE END-USER DEVELOPED AN ASTHMA ATTACK AFTER WEARING AN ANTIVIRAL FACE MASK. END-USER HAS A KNOWN HISTORY OF PNEUMONIA AND ASTHMA AND WAS INSTRUCTED TO WEAR A FACE MASK IN PUBLIC DUE TO LOW IMMUNITY RELATED TO PNEUMONIA. END-USER WORE THE ANTIVIRAL MASK ONE TIME WITH NO ISSUE, WHEN SHE WORE A MASK A SECOND TIME SHE DEVELOPED AN ASTHMATIC RESPONSE. END-USER WENT TO THE LOCAL EMERGENCY DEPARTMENT AND WAS TREATED WITH INHALED BREATHING TREATMENTS AND INTRAVENOUS MAGNESIUM. THE SYMPTOMS SUBSIDED AND END-USER WAS DISCHARGED HOME FROM THE EMERGENCY DEPARTMENT. END-USER DISCARDED THE FACE MASKS AND A SAMPLE WAS NOT RETURNED. A ROOT CAUSE CANNOT BE DETERMINED. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION THIS MEDWATCH IS BEING FILED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT DEVELOPED AN ALLERGIC REACTION AFTER WEARING ANTIVIRAL FACEMASK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332283 ANTIVIRAL FACEMASK OUK MEDLINE INDUSTRIES INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention