BEUDAMED
    FDA Adverse Event Other Summary report: N

    FACE MASK, EAR LOOP

    MDR report key: 511264 · Received February 12, 2004

    Report

    Report Number
    1423507-2004-00013
    Event Type
    Other
    Date Received
    February 12, 2004
    Report Date
    January 28, 2004
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FXX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    END USER CUSTOMER REPORTED TO PLACE OF PURCHASE (PHARMACY): WHILE MOVING OUT OF THEIR MOLD INFESTED APARTMENT CUSTOMER DONNED THE SECURE GUARD MASK AND IMMEDIATELY HAD SWELLING TO THEIR MOUTH AND FACE AND HAD DIFFICULTY BREATHING. END USER WAS SEEN AND RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FACE MASK, EAR LOOP FACE MASK, EAR LOOP FXX CARDINAL HEALTH AT7511 3093-021

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other