BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 10785931 · Received November 4, 2020

    Report

    Report Number
    1523658-2020-00057
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    May 13, 2020
    Report Date
    November 3, 2020
    Manufacturer
    BATTELLE MEMORIAL INSTITUTE
    Product Code
    QKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THE DECON SITES ARE NOT THE SOURCE OF MAKE-UP / GENERAL SOILING, THE HCP SHOULD NOT BE SENDING THESE TO US. MASK STRAPS AND LOOSE FIT ISSUES ARE DUE TO FACTORS SUCH AS WEAR OVER TIME AND MASKS BEING USED ON DIFFERENT USERS (AS CONFIRMED BY MARION GENERAL THE MASKS DO NOT GO BACK TO THE ORIGINAL USER). GENERAL REPEATED HANDING WHILE IN USE, DONNING, DOFFING, SHIPPING TO DECONS SITES, LOADING, UNLOADING, RETURN SHIPMENT AND UNPACKING AT THE HCP ARE ALL FACTORS OF PROPER FIT. FACT SHEETS ARE SENT TO THE HCP TO DISCARD ANY SOILED OR DAMAGED MASK PRIOR TO SENDING FOR DECON. 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 MAKEUP ON MASK. 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
    1251001 NA RESPIRATOR, DECONTAMINATED QKY BATTELLE MEMORIAL INSTITUTE

    Patients

    Seq Age Sex Outcome Treatment
    1