BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 10764048 · Received October 30, 2020

    Report

    Report Number
    1523658-2020-00011
    Event Type
    Malfunction
    Date Received
    October 30, 2020
    Report Date
    November 11, 2020
    Manufacturer
    BATTELLE MEMORIAL INSTITUTE
    Product Code
    QKY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION OF PRODUCT CODE FROM QLA TO QKY BASED ON FDA FEEDBACK.

    Additional Manufacturer Narrative · 1

    ALTHOUGH NO MALFUNCTION OR SERIOUS INJURY OF THE DECONTAMINATED RESPIRATOR HAS BEEN CONFIRMED, THIS REPORT IS REQUIRED UNDER THE TERMS OF THE EUA. CCDS STAFF HAS BEEN IN CONTACT WITH HCP, EXPLAINING THE DECONTAMINATION PROCESS, THE CHEMICALS USED (SDSS), AND PROVIDED A LINK TO FAQS FOR HCPS AS WELL AS SUGGESTING AIRING OUT THE MASKS PRIOR TO USE. 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 SIGNIFICANT COUGH, SORE THROAT, BURNING IN CHEST AND ESOPHAGUS, CHEST TIGHTNESS. THE MASK ASSOCIATED WITH THIS EVENT WAS DECONTAMINATED WITH THE BATTELLE CCDS "CLOSED SYSTEM" PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229770 NA RESPIRATOR, DECONTAMINATED QKY BATTELLE MEMORIAL INSTITUTE

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other