BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRRISEPT ANTIMICROBIAL WOUND LAVAGE

    MDR report key: 21469171 · Received February 26, 2025

    Report

    Report Number
    3005706359-2025-00002
    Event Type
    Injury
    Date Received
    February 26, 2025
    Date of Event
    February 10, 2024
    Report Date
    February 17, 2025
    Manufacturer
    IRRIMAX CORPORATION
    Product Code
    FQH
    UDI-DI
    10842351190002
    PMA / PMN Number
    K210536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FEB 2024 EVENT WAS REPORTED TO THE MANUFACTURER ON 28JAN2025. CONTACT WITH THE PHYSICIAN FOUND THAT THE PRODUCT HAS BEEN USED CONSISTENTLY FOR APPROXIMATELY 2 YEARS. WHILE THE REPORTED PATIENT CONDITION CAN DEVELOP AFTER THIS PROCEDURE AND NO DIRECT CORRELATION TO THE DEVICE HAS BEEN IDENTIFIED, THE EVENT IS BEING INVESTIGATED AND REPORTED FOR COMPLETENESS. THE PHYSICIAN CONTINUES TO USE THE PRODUCT. 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

    ACCORDING TO THE INFORMATION AVAILABLE, ON APPROXIMATELY (B)(6) 2024 AND AFTER HAVING BEEN ASSESSED FOR OVER A DECADE, THE INVOLVED PATIENT UNDERWENT MICROVASCULAR DECOMPRESSION FOR TRIGEMINAL NEURALGIA. THE PRODUCT WAS USED FOR IRRIGATION. POST-PROCEDURE, THE PATIENT DEVELOPED HYDROCEPHALUS AND REQUIRED A VP SHUNT. BASED UPON THE INFORMATION PROVIDED, SYMPTOM MANAGEMENT IS BEING ACHIEVED, AND THE SHUNT SHOULD BE ABLE TO BE TURNED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659145 IRRISEPT ANTIMICROBIAL WOUND LAVAGE JET LAVAGE FQH IRRIMAX CORPORATION ISEPT-450-USA UNKNOWN 10842351190002

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Required Intervention| H