BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N95 1860

    MDR report key: 11146551 · Received January 11, 2021

    Report

    Report Number
    11146551
    Event Type
    Malfunction
    Date Received
    January 11, 2021
    Date of Event
    December 11, 2020
    Report Date
    January 8, 2021
    Manufacturer
    3M COMPANY
    Product Code
    MSH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IN (B)(6), NURSES BEGAN REPORTING CONCERNS ABOUT THE WAY THEIR N95'S FIT AND FELT. THEY DESCRIBED THE MASKS AS FEELING THINNER, STRAPS FELT LOOSE, AND WERE UNABLE TO OBTAIN A SEAL AND IN GENERAL "DID NOT FEEL RIGHT". THESE MASKS WERE DISTRIBUTED TO THE HOSPITAL BY 3M FROM AN OUTSIDE VENDOR. 3M WAS NOT THE MANUFACTURER OF THESE MASKS. SUPPLY CHAIN INFORMED 3M OF THIS ISSUE. ALL MASKS WITH THE LOT NUMBERS LISTED WERE IMMEDIATELY PULLED FROM THE HOSPITAL SHELVES AND RETURNED TO 3M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44582 N95 1860 RESPIRATOR, SURGICAL MSH 3M COMPANY B20016/B20522

    Patients

    Seq Age Sex Outcome Treatment
    1