BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M N95 MASK

    MDR report key: 10983210 · Received December 9, 2020

    Report

    Report Number
    MW5098290
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    April 12, 2020
    Report Date
    July 12, 2020
    Manufacturer
    3M COMPANY
    Product Code
    FXX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A 3M SMALL (1860S) N95 MASKS RECEIVED FROM MANUFACTURER DEFECTIVE, MISSING ONE OF THE 2 STRAPS. LOT #210190. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438460 3M N95 MASK MASK, SURGICAL FXX 3M COMPANY 1860S 210190

    Patients

    Seq Age Sex Outcome Treatment
    1