BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M¿

    MDR report key: 12922839 · Received December 3, 2021

    Report

    Report Number
    12922839
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    October 21, 2021
    Report Date
    November 18, 2021
    Manufacturer
    3M COMPANY
    Product Code
    FXX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A FELLOW MD FROM THE MEDICAL TEAM AT THE SHOCK TRAUMA INTENSIVE CARE UNIT EXPERIENCED AN INCIDENT WITH A 3M¿ HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK 1860S N95. STAFF MEMBER PLACED MASK ON CORRECTLY, INHALED FIBERS/DUST FROM MASK UPON DONNING. THE BOX OF 1860S N-95 MASK WERE NOT OPENED (LOT # B20756).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825543 3M¿ MASK, SURGICAL FXX 3M COMPANY 1860S B20756

    Patients

    Seq Age Sex Outcome Treatment
    1 Male