MAUDE Adverse Event Report: IRRIMAX CORPORATION IRRISEPT ANTIMICROBIAL WOUND LAVAGE; JET LAVAGE

Model Number	ISEPT-450-USA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	02/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: IRRISEPT ANTIMICROBIAL WOUND LAVAGE
• Common Device Name: JET LAVAGE
• Manufacturer (Section D): IRRIMAX CORPORATION; 1665 lakes parkway, suite 102; lawrenceville GA 30043 5879
• Manufacturer (Section G): MEDLINE INDUSTRIES (MUNDELEIN PACKAGING); 1 medline place; mundelein IL 60060
• Manufacturer Contact: rick holecek ; 1665 lakes parkway, suite 102; lawrenceville, GA 30043-5879 ; 7708078445
• MDR Report Key: 21469171
• Report Number: 3005706359-2025-00002
• Device Sequence Number: 3492247
• Product Code: FQH
• UDI-Device Identifier: 10842351190002
• UDI-Public: 10842351190002
• Combination Product (Y/N): Y
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K210536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ISEPT-450-USA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 38 YR
• Patient Sex: Male