BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN EARLOOP FACE MASKS

    MDR report key: 1821445 · Received August 25, 2010

    Report

    Report Number
    2411236-2010-00003
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 15, 2010
    Manufacturer
    A.R. MEDICOM, INC.
    Product Code
    FXX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT A (B)(6) FEMALE DENTAL ASSISTANT IN (B)(6), EXPERIENCED A SKIN IRRITATION, RASH, BLISTERS, REDNESS, AND SWELLING TO HER FACE FROM THE FACEMASKS. THE ASSISTANT HAD TO SEEK MEDICAL ATTENTION AND WAS PRESCRIBED A CORTISONE INJECTION AND CORTISONE SALVE ALONG WITH DRUGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HENRY SCHEIN EARLOOP FACE MASKS EARLOOP FACE MASKS FXX A.R. MEDICOM, INC. 940038

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR