BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRRISEPT ANTIMICROBIAL WOUND LAVAGE

    MDR report key: 21756123 · Received April 2, 2025

    Report

    Report Number
    3005706359-2025-00003
    Event Type
    Injury
    Date Received
    April 2, 2025
    Date of Event
    January 1, 2022
    Report Date
    April 1, 2025
    Manufacturer
    IRRIMAX CORPORATION
    Product Code
    FQH
    UDI-DI
    10842351190002
    PMA / PMN Number
    K210536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS REPORTED TO THE MANUFACTURER ON 04MAR2025 (EVENT OCCURRENCE WAS DURING YEAR 2022 - EXACT DATE UNKNOWN). CONTACT WITH THE OR DIRECTOR FOUND THAT THE PRODUCT HAS BEEN USED CONSISTENTLY FOR APPROXIMATELY 3 YEARS. WHILE THE REPORTED PATIENT CONDITION CAN DEVELOP WITH CARDIAC PROCEDURES AND NO DIRECT CORRELATION TO THE PRODUCT HAS BEEN IDENTIFIED, THE EVENT WAS ASSESSED TO QUALIFY AS A REPORTABLE EVENT AND IS LODGED FOR COMPLETENESS. THIS REPORT IS BASED UPON INFORMATION PROVIDED TO THE MANUFACTURER. BLANK FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED BY PHYSICIAN REPORTING THE EVENT, WAS NOT AVAILABLE, OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION TO OR CONCLUSION BY FDA, THE MANUFACTURER, OR ITS EMPLOYEES OR AGENTS THAT THE DEVICE, THE MANUFACTURER, OR ITS EMPLOYEES OR AGENTS CAUSED, CONTRIBUTED IN ANY WAY TO, OR ANY WAY IS CONNECTED WITH THE EVENT(S) DESCRIBED IN THIS REPORT. THE PREVIOUS PARAGRAPH SHALL BE INCLUDED IN ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC INCLUDING INFORMATION OR REPORTS PROVIDED UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    ON (B)(6) 2025, IT WAS REPORTED THAT A PATIENT UNDERWENT CARDIAC SURGERY WHERE IRRISEPT WAS USED FOR IRRIGATION. ACCORDING TO THE EVENT INFORMATION PROVIDED, THE PRODUCT WAS USED IN THE PROCEDURE AND DUE TO THE SURGICAL CONDITIONS PRESENT, THE FLUID WAS BELIEVED TO HAVE COME INTO CONTACT WITH THE PATIENT INTRAVASCULARLY. THE PATIENT PRESENTED INCREASED VALUES OF LACTIC ACID WHICH WAS TREATED AND RESOLVED. IT WAS ALSO STATED THAT THESE ISSUES DATE BACK TO 2022. NO ADDITIONAL PATIENT HARM OR INTERVENTION WAS REQUIRED OR REPORTED. NO OTHER INFORMATION ABOUT THE PATIENT WAS PROVIDED. IRRIMAX ADVISED THAT IRRISEPT SHOULD NOT BE USED WHEN POTENTIAL FOR INTRAVASCULAR INJECTION IS POSSIBLE AS THE PRODUCT LABELING STATES "NOT FOR INJECTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2334152 IRRISEPT ANTIMICROBIAL WOUND LAVAGE JET LAVAGE FQH IRRIMAX CORPORATION ISEPT-450-USA UNKNOWN 10842351190002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention