BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M ASEPTEX MOLDED SURGICAL MASK, 1800+NL

    MDR report key: 2042061 · Received March 29, 2011

    Report

    Report Number
    2110898-2011-00032
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 1, 2011
    Manufacturer
    3M HEALTH CARE
    Product Code
    FXX
    PMA / PMN Number
    K881618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT AVAILABLE. CONCLUSIONS - NO EVALUATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    3M RECEIVED INFORMATION FROM A NURSE WITH NO HISTORY OF REACTION TO OTHER MASKS, REPORTED THAT HER FACE FEELS LIKE IT IS ON FIRE AFTER USING THE 3M ASEPTEX MOLDED SURGICAL MASK. SHE DEVELOPS REDNESS AND BLOTCHINESS EVERYWHERE UNDER THE MASK, AS WELL AS EXPERIENCING THE SAME SYMPTOMS UNDER THE STRAP. REPORTEDLY, SHE HAS BEEN TO THE EMERGENCY ROOM SEVEN TIMES FOR TACHYCARDIA AND SHORTNESS OF BREATH. SHE HAS ALSO HAD ELECTROCARDIOGRAMS TAKEN AND HAS RECEIVED NO TREATMENT. SHE HAS SEEN A CARDIOLOGIST AND THEY HAVE ISOLATED HER SYMPTOMS TO THE MASK. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE EXPIRATION DATE CANNOT BE DETERMINED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M ASEPTEX MOLDED SURGICAL MASK, 1800+NL NONE FXX 3M HEALTH CARE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention