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

Model Number	ISEPT-450-USA
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Circulator opened irrisept package aseptically to scrub tech.Scrub tech opened outer wrap and hair was noted on the protective ring.Scrub tech passed it back to circulator and changed outer gloves.Hair secured to protective ring with tape where found to prevent loss.Packaging and product with hair saved for or quality.

• 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: 12438312
• Report Number: 12438312
• Device Sequence Number: 4892324
• Product Code: FQH
• UDI-Device Identifier: 00842351190005
• UDI-Public: (01)00842351190005(17)230531(10)21EDB762
• 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): 08/25/2021
• Report Date (Section F): 08/25/2021

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
• Operator of Device: Health Professional
• Device Model Number: ISEPT-450-USA
• Device Catalogue Number: 9000
• Device Lot Number: 21EDB762
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/25/2021