BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUIDSHIELD FOG-FREE PROCEDURE MASK WITH SO SOFT LINING AND EARLOOPS ORANGE

    MDR report key: 18171838 · Received November 20, 2023

    Report

    Report Number
    9616096-2023-00086
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Report Date
    January 16, 2024
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FXX
    UDI-DI
    30680651471070
    PMA / PMN Number
    K110455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THIS COMPLAINT WAS NOT RETURNED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. H3 OTHER TEXT : DEVICE NOT RETURNED

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALATION. THE INVESTIGATION WAS PERFORMED PER INFORMATION PROVIDED BY THE CUSTOMER. A SAMPLE, PHOTO OR LOT NUMBER WAS NOT AVAILABLE TO PERFORM AN EVALUATION. WE WERE UNABLE TO REVIEW THE DEVICE HISTORY RECORD FOR THIS COMPLAINT GIVEN THE REPORTER DID NOT PROVIDE A COMPLAINT LOT NUMBER. WE REACHED OUT TO THE CUSTOMER FOR ADDITIONAL INFORMATION AND THE REPORTER HAS NOT RESPONDED. BASED ON THE INFORMATION AVAILABLE AND INVESTIGATION PERFORMED, A ROOT CAUSE WAS NOT IDENTIFIED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    THE CUSTOMER STATED IT IS DIFFICULT TO BREATHE IN BECAUSE OF THE 3 LAYER THICKNESS. ADDITIONAL INFORMATION WAS REQUESTED ABOUT THIS INCIDENT BUT NOT RECEIVED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2165694 FLUIDSHIELD FOG-FREE PROCEDURE MASK WITH SO SOFT LINING AND EARLOOPS ORANGE ICP FACIAL PROTECTION FXX O&M HALYARD, INC. 47107 UNKNOWN 30680651471070

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown