BEUDAMED
    FDA Adverse Event Other Summary report: N

    MASK SURG TIE SECURE BILL SECURE GARD

    MDR report key: 1616829 · Received February 9, 2010

    Report

    Report Number
    1423507-2010-00010
    Event Type
    Other
    Date Received
    February 9, 2010
    Date of Event
    January 12, 2010
    Report Date
    February 9, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FXX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBERS REPORTED BT THE CUSTOMERS ARE: 09073H25 (03/2007 MFR, 03/2012 EXPIRE), 09LCH323 (11/2009 MFR, 11/2014 EXPIRE), 09MCH338 (12/2009 MFR, 12/2014 EXPIRE), 09ECH138 (05/2009 MFR, 05/2014 EXPIRE). THE COMPLAINT WAS FORWARDED TO THE MANUFACTURING FACILITY FOR INVESTIGATION. A F/U REPORT WILL BE FILED ONCE THEIR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING NUMEROUS COMPLAINTS FROM THE STAFF THAT THE MASK FEELS "FUZZY" AROUND THE NOSE (LIKE FIBERS ARE STICKING OUT OF THE MASK) CAUSING ITCHING AND REDNESS OF SKIN ON FACE. APPARENTLY THREE EMPLOYEES WENT TO EMPLOYEE HEALTH FOR TREATMENT. THE EMPLOYEES WERE SWITCHED TO A DIFFERENT MASK AND THEIR SYMPTOMS SUBSIDED. THIS IS ALL THE INFO THE CUSTOMER HAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MASK SURG TIE SECURE BILL SECURE GARD SURGICAL MASK FXX CARDINAL HEALTH 09073H25

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other