BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOLDEX MASK

    MDR report key: 10634590 · Received October 5, 2020

    Report

    Report Number
    MW5097094
    Event Type
    Injury
    Date Received
    October 5, 2020
    Date of Event
    September 22, 2020
    Report Date
    October 2, 2020
    Manufacturer
    MOLDEX/METRIC, INC.
    Product Code
    MSH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FACIAL SWELLING, EYE SWELLING, BURNING EYES, ITCHING LIPS, BURNING LIPS, SNEEZING, COUGHING, BURNING IN CHEST. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090109 MOLDEX MASK RESPIRATOR, SURGICAL MSH MOLDEX/METRIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR