BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 10896352 · Received November 24, 2020

    Report

    Report Number
    1523658-2020-00213
    Event Type
    Injury
    Date Received
    November 24, 2020
    Date of Event
    November 11, 2020
    Report Date
    November 23, 2020
    Manufacturer
    BATTELLE MEMORIAL INSTITUTE
    Product Code
    QKY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WAITING FOR MASK TO BE RETURNED FOR EVALUATION. CCDS STAFF HAS BEEN IN CONTACT WITH HCP, AND PROVIDED SDSS REQUESTED. ALTHOUGH NO MALFUNCTION OR SERIOUS INJURY OF THE DECONTAMINATED RESPIRATOR HAS BEEN CONFIRMED, THIS REPORT IS REQUIRED UNDER THE TERMS OF THE EUA. ALL INFORMATION KNOWN OR REASONABLY KNOWN TO BATTELLE HAS BEEN INCLUDED IN THIS SUBMISSION. ANY BLANK FIELDS INDICATE THAT INFORMATION WAS UNAVAILABLE.

    Description of Event or Problem · 1

    USER REPORTED ASTHMA ATTACK. THE MASKS ASSOCIATED WITH THIS EVENT WERE DECONTAMINATED WITH THE BATTELLE CCDS "CLOSED SYSTEM" PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360824 NA RESPIRATOR, DECONTAMINATED QKY BATTELLE MEMORIAL INSTITUTE

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other