BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRRISEPT ANTIMICROBIAL WOUND LAVAGE

    MDR report key: 23486730 · Received November 6, 2025

    Report

    Report Number
    3005706359-2025-00005
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    October 2, 2025
    Report Date
    November 5, 2025
    Manufacturer
    IRRIMAX CORPORATION
    Product Code
    FQH
    PMA / PMN Number
    K210536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGH ADDITIONAL EFFORTS, NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE REGARDING THE REPORTED EVENT OR IDENTIFICATION OF THE SPECIFIC PRODUCT/LOT NUMBER TO ALLOW FURTHER INVESTIGATION. 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

    PHYSICIAN REPORTED THAT, AFTER DISCHARGE FROM THE HOSPITAL, A PATIENTS EXPERIENCED UPPER BODY RASH SPREADING FROM THE SURGICAL WOUND SITE. THE PHYSICIAN BELIEVES THE RASH MAY HAVE BEEN CAUSED BY THE USE OF EITHER ISEPT-500-INT OR ISEPT-150-INT DURING THE PROCEDURE.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED THAT, AFTER DISCHARGE FROM THE HOSPITAL, A PATIENT EXPERIENCED UPPER BODY RASH SPREADING FROM THE SURGICAL WOUND SITE. THE PHYSICIAN BELIEVES THE RASH MAY HAVE BEEN CAUSED BY THE USE OF EITHER ON ISEPT-450-USA OR ISEPT-150-USA DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2637848 IRRISEPT ANTIMICROBIAL WOUND LAVAGE JET LAVAGE FQH IRRIMAX CORPORATION ISEPT-500-INT/ ISEPT-150-INT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention