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

Model Number	ISEPT-450-USA
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Bottle leaking prior to opening, this was found prior to opening, bottle not used or presented to sterile field.

• Brand Name: IRRISEPT ANTIMICROBIAL WOUND LAVAGE
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): IRRIMAX CORPORATION; 1665 lakes parkway; suite 102; lawrenceville GA 30043
• MDR Report Key: 16495009
• Report Number: 16495009
• Device Sequence Number: 6366395
• Product Code: FQH
• UDI-Device Identifier: 00842351190005
• UDI-Public: (01)00842351190005(17)241130(10)22K
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2023
• Report Date (Section F): 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ISEPT-450-USA
• Device Catalogue Number: 9000
• Device Lot Number: 22K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/15/2023