BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 10777581 · Received November 3, 2020

    Report

    Report Number
    1523658-2020-00015
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Report Date
    November 2, 2020
    Manufacturer
    BATTELLE MEMORIAL INSTITUTE
    Product Code
    QLA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION INITIALLY RECEIVED THROUGH FDA MEDWATCH (MW5094220) PER CCDS TICKET (B)(4). DEVICE NOT RETURNED FOR EVALUATION. ALL INFORMATION KNOWN OR REASONABLY KNOWN TO BATTELLE HAS BEEN INCLUDED IN THIS SUBMISSION. ANY BLANK FIELDS INDICATE THAT INFORMATION WAS UNAVAILABLE. REVIEW OF THE PROCESS AND DATA BY BATTELLE AND 3M SUPPORTS THE INVESTIGATION FINDING, THAT THERE ARE NO KNOWN ADVERSE EFFECTS WITH USING THE H202 BATTELLE DECONTAMINATION PROCESS WITHIN THE GUIDELINES OF THE APPROVED PROCEDURES. ALTHOUGH NO MALFUNCTION OR SERIOUS INJURY OF THE DECONTAMINATED RESPIRATOR HAS BEEN CONFIRMED, THIS REPORT IS REQUIRED UNDER THE TERMS OF THE EUA.

    Description of Event or Problem · 1

    USER REPORTED N95 MASKS WERE NOT SEALING PROPERLY AND SHORTNESS OF BREATH. THE MASKS ASSOCIATED WITH THIS EVENT WERE PART OF THE BATTELLE CCDS "CLOSED SYSTEM" PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247169 NA RESPIRATOR, DECONTAMINATED QLA BATTELLE MEMORIAL INSTITUTE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other