BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 10794956 · Received November 5, 2020

    Report

    Report Number
    1523658-2020-00128
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    June 25, 2020
    Report Date
    November 4, 2020
    Manufacturer
    BATTELLE MEMORIAL INSTITUTE
    Product Code
    QKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. CCDS STAFF EXPLAINED THAT UNPACKING, LOADING AND UNLOADING OF THE MASK INTO AND OUT OF THE CHAMBER THEN REPACKING INTO THE BAGS CAN HAVE AN EFFECT ON THE FIT QUALITY. ALL INFORMATION KNOWN OR REASONABLY KNOWN TO BATTELLE HAS BEEN INCLUDED IN THIS SUBMISSION.

    Description of Event or Problem · 1

    USER REPORTED MASKS DO NOT KEEP THE SHAPE OR RIGID INTEGRITY. 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
    1257295 NA RESPIRATOR, DECONTAMINATED QKY BATTELLE MEMORIAL INSTITUTE

    Patients

    Seq Age Sex Outcome Treatment
    1