BEUDAMED
    FDA Adverse Event Other Summary report: N

    3-M DUCKBILL SURGICAL MASK

    MDR report key: 144827 · Received January 16, 1998

    Report

    Report Number
    144827
    Event Type
    Other
    Date Received
    January 16, 1998
    Date of Event
    July 15, 1997
    Report Date
    January 14, 1998
    Manufacturer
    3-M CORP
    Product Code
    FXX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY TWELVE NURSES EXPERIENCED FACIAL DERMATITIS WHILE USING THE 3-M DUCKBILL SURGICAL MASKS. WHEN EMPLOYEES QUIT USING THE MASK THE DERMATITIS RAPIDLY CLEARED UP WITH THE EXCEPTION OF ONE NURSE. SHE FILED FOR WORKER'S COMPENSATION AND CONTINUED TO HAVE THE DERMATITIS FOR ABOUT ONE MONTH. THE MASKS WRE REMOVED FROM INVENTORY AND 3-M REPRESENTIVE WAS NOTIFIED OF THE PROBLEM. ORIGINALLY HOSP THOUGHT THAT THEIR HOSP WAS THE ONLY HOSPITAL WHO WAS EXPERIENCING THE PROBLEM. LATER, THEY DISCOVERED THAT OTHER HOSPITALS WERE EXPERIENCING THE SAME PROBLEM. 3-M HAS SINCE DISCOVERED THAT THERE WERE PROBLEMS ASSOCIATED WITH THE THREE FOLLOWING LOT NUMBERS: 2002-06CZ, 2002-07CW & 2002-07DC. THESE MASKS WERE DISCOVERED TO HAVE AN EXCESS OF FUZZY MATERIAL ALONG THE EDGES. THEY ARE INVESTIGATING THE MFG PROCESS IN AN EFFORT TO ELIMINATE THIS PROBLEM. BECAUSE THIS INCIDENT WAS NOT CONSIDERED A SERIOUS INJURY A WRITTEN REPORT WAS NOT FILED WITH THE MFR AND FDA AT THE TIME OF OCCURRENCE. AFTER SPEAKING WITH A REPRESENTATIVE FROM THE FDA ABOUT THE SITUATION, HOSP FELT THAT IT WOULD BE WORTH WHILE TO FILE A WRITTEN REPORT IN CASE THERE NEEDED TO BE A RECALL OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3-M DUCKBILL SURGICAL MASK SURGICAL MASK FXX 3-M CORP 3-M 1838 FILTRON SURGICAL MASK 2002-6CZ,2002-07CW,2002-07DC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other