BEUDAMED
    FDA Adverse Event Other Summary report: N

    HENRY SCHEIN EARLOOP FACE MASKS

    MDR report key: 1872646 · Received October 5, 2010

    Report

    Report Number
    9680179-2010-00002
    Event Type
    Other
    Date Received
    October 5, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 15, 2010
    Manufacturer
    A.R. MEDICOM, INC.
    Product Code
    FXX
    PMA / PMN Number
    K051291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INNER LAYER OF THIS MASK IS THE SAME MATERIAL DENSITY (25GSM) AND COMING FROM THE SAME RAW MATERIAL SUPPLIER AS ON THE ORIGINAL 510K APPLICATION. CYTOTOXICITY, DERMAL SENSITIZATION AND SKIN IRRITATION STUDIES WERE CONDUCTED IN 2005 AND SHOWED NO ABNORMALITIES OR REACTION. THE CURRENT COMPLAINT ON SKIN REACTION WAS LOGGED AT AR MEDICOM (B)(4). TEN (10) MASKS COMING FROM THE SAME BOX AS THE COMPLAINT SAMPLE WAS TRIED BY TEN (10) VOLUNTEERS AT MEDICOM (B)(4) AS WELL AS THE SAME TEN (10) VOLUNTEERS WORN MASKS COMING FROM THE SAME LOT RESERVED SAMPLES AND NO SKIN IRRITATIONS WERE OBSERVED. THE MANUFACTURING BATCH RECORD WAS REVIEWED AND NOTHING PARTICULAR WAS FOUND AND PRODUCT WAS RELEASED WITHOUT ANY REMARKS. (B)(4). SINCE THOSE REACTIONS HAPPENED ON LESS THAN 0.001% OF MASKS SOLD IN USA AND NO SERIOUS INJURY WERE REPORTED TO MEDICOM; IT WAS DECIDED, FOR THE MOMENT, TO STILL CONTINUING MONITORING COMPLAINTS. CONCLUSION: THE INNER LAYER MATERIAL WITH THE PRODUCT LOT NO. 940038 COULD BE ACCEPTED BY THE WEARING TEST VOLUNTEERS. FOR THIS COMPLAINT, IT COULD BE PERSONNEL PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT A (B)(6) FEMALE 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 Other