BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 18100973 · Received November 9, 2023

    Report

    Report Number
    9616096-2023-00085
    Event Type
    Injury
    Date Received
    November 9, 2023
    Report Date
    January 4, 2024
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FXX
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. 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.

    Description of Event or Problem · 0

    THE CUSTOMER INDICATED THAT THEY PURCHASED O&M HALYARD MASKS AND RECENTLY RECEIVED A RECALL NOTICE. THE CUSTOMER USED SOME OF THE MASKS AND "GOT COVID SHORTLY BEFORE RECEIVING THE NOTICE." THE CUSTOMER DID NOT PROVIDE A PRODUCT CODE OR A LOT NUMBER FOR THIS INCIDENT. NO ADDITIONAL INFORMATION PROVIDED. O&M HALYARD REACHED OUT TO THE CUSTOMER ON OCTOBER 13, 17, AND 19TH IN AN ATTEMPT TO ACQUIRE ADDITIONAL DETAILS REGARDING THE ALLEGED COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1803592 UNKNOWN UNKNOWN FXX O&M HALYARD, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other