BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 10793303 · Received November 5, 2020

    Report

    Report Number
    1523658-2020-00099
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    May 27, 2020
    Report Date
    November 4, 2020
    Manufacturer
    BATTELLE MEMORIAL INSTITUTE
    Product Code
    QKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. SINCE THE TIME OF ISSUE, NO OTHER CONCERNS OR COMPLAINTS REGARDING THE MASKS HAVE BEEN REPORTED BY HOSPITAL STAFF. 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 MASK STRAP GOT A DIVOT IN THE ELASTIC AND STARTED TEARING. 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
    1258534 NA RESPIRATOR, DECONTAMINATED QKY BATTELLE MEMORIAL INSTITUTE

    Patients

    Seq Age Sex Outcome Treatment
    1