BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 10504685 · Received September 8, 2020

    Report

    Report Number
    1523658-2020-00001
    Event Type
    Injury
    Date Received
    September 8, 2020
    Date of Event
    August 7, 2020
    Report Date
    August 19, 2021
    Manufacturer
    BATTELLE MEMORIAL INSTITUTE
    Product Code
    QKY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION OF PRODUCT CODE FROM QLA TO QKY BASED ON FDA FEEDBACK. CORRECTED RESUSE AND REPROCESSOR INFORMATION.

    Additional Manufacturer Narrative · 0

    ALTHOUGH NO MALFUNCTION OR SERIOUS INJURY OF THE DECONTAMINATED RESPIRATOR HAS BEEN CONFIRMED, THIS REPORT IS REQUIRED, AS A FOLLOW-UP TO A PREVIOUSLY REPORTED EVENT, UNDER THE TERMS OF THE EUA.

    Description of Event or Problem · 0

    USER REPORTED REDNESS AND IRRITATION FROM A DECONTAMINATED MASK AT THE BEGINNING OF THE WEEK AND THAT THE IRRITATION PROGRESSED TO A CHEMICAL BURN BY THE END OF THE WEEK. USER HAS WORN REPROCESSED MASKS PREVIOUSLY WITH NO ISSUES. THE MASKS ASSOCIATED WITH THIS EVENT WERE DECONTAMINATED WITH THE BATTELLE CCDS "CLOSED SYSTEM" PROCESS.

    Description of Event or Problem · 0

    BATTELLE IS SUBMITTING THIS FOLLOW UP REPORT TO PROVIDE ADDITIONAL INFORMATION ABOUT A PREVIOUSLY REPORTED EVENT. BATTELLE PREVIOUSLY REPORTED, TO THE FDA, THAT A HEALTH CARE PERSONNEL (HCP) REPORTED REDNESS AND IRRITATION FROM A DECONTAMINATED RESPIRATOR AT THE BEGINNING OF THE WEEK AND THAT THE IRRITATION PROGRESSED TO A CHEMICAL BURN BY THE END OF THE WEEK. BATTELLE ALSO REPORTED THAT THE HCP HAD WORN DECONTAMINATED RESPIRATORS PREVIOUSLY WITH NO ISSUES. BATTELLE HAS SINCE OBTAINED NEW INFORMATION ABOUT THIS EVENT. THE NEW INFORMATION IS BASED ON ALLEGATIONS IN A FILED LAWSUIT. WHILE UNSUBSTANTIATED, PLAINTIFF ALLEGES EXPERIENCING CAUSTIC BURN, LESIONS, CHRONIC HEADACHES, HYPERPIGMENTATION, ERYTHEMA, SPIDER VEINS, CHEMICAL GAS INHALATION, AND RESPIRATORY DISTRESS IN ASSOCIATION WITH USE OF A DECONTAMINATED RESPIRATOR. PLAINTIFF ALLEGES THAT THE RESPIRATOR ASSOCIATED WITH THIS EVENT WAS DECONTAMINATED WITH THE BATTELLE CCDS. BATTELLE PREVIOUSLY FOLLOWED UP FOUR TIMES WITH THE HEALTH CARE FACILITY (HCF) THAT INITIALLY REPORTED THE ISSUE. BATTELLE FOLLOWED UP BY PHONE AND BY EMAIL TO OBTAIN ADDITIONAL INFORMATION, INCLUDING REQUESTING THE DECONTAMINATED RESPIRATOR AT ISSUE. THE HCF REPORTED 2 DECONTAMINATION RUN NUMBERS THAT THIS RESPIRATOR COULD HAVE BEEN PROCESSED UNDER, BUT THE HCF COULD NOT CONFIRM THAT THESE RUN NUMBERS WERE IN FACT CORRECT. BATTELLE QA RETRIEVED THE DECONTAMINATION PROCESS RUN DATA AND REVIEWED AND FOUND NO ISSUES NOTED DURING THESE RUN CYCLES. WITH THE INFORMATION AVAILABLE, A ROOT CAUSE OF THE EVENT COULD NOT BE IDENTIFIED. SINCE THIS IS CURRENTLY A LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO BATTELLE LEGAL COUNSEL AND FURTHER INFORMATION OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER ATTORNEY-CLIENT OR ATTORNEY WORK-PRODUCT PRIVILEGE. BATTELLE WILL SUPPLEMENT THIS REPORT IF IT BECOMES AWARE OF ADDITIONAL INFORMATION REQUIRED TO BE REPORTED UNDER 21 C.F.R. PART 803, AS APPROPRIATE.

    Description of Event or Problem · 1

    USER REPORTED REDNESS AND IRRITATION FROM A DECONTAMINATED MASK AT THE BEGINNING OF THE WEEK AND THAT THE IRRITATION PROGRESSED TO A CHEMICAL BURN BY THE END OF THE WEEK. USER HAS WORN REPROCESSED MASKS PREVIOUSLY WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964864 N/A RESPIRATOR, DECONTAMINATED QKY BATTELLE MEMORIAL INSTITUTE

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Disability