BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 10796498 · Received November 5, 2020

    Report

    Report Number
    1523658-2020-00144
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Report Date
    November 5, 2020
    Manufacturer
    BATTELLE MEMORIAL INSTITUTE
    Product Code
    QKY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. CCDS STAFF HAVE PROVIDED ADDITIONAL INFORMATION CONCERNING THE DECONTAMINATION PROCESS AS WELL AS SDSS FOR THE CHEMICALS USED. 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.

    Description of Event or Problem · 1

    USER REPORTED LIGHTHEADEDNESS. 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
    1255482 NA RESPIRATOR, DECONTAMINATED QKY BATTELLE MEMORIAL INSTITUTE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other