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

Model Number ISEPT-450-USA

Device Problems Fluid/Blood Leak (1250); Device Difficult to Setup or Prepare (1487)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2023

Event Type  malfunction  

Event 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
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): IRRIMAX CORPORATION; 1665 lakes parkway; suite 102; lawrenceville GA 30043
• MDR Report Key: 16495009
• MDR Text Key: 310804794
• Report Number: 16495009
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00842351190005
• UDI-Public: (01)00842351190005(17)241130(10)22K
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Date Report Sent to FDA: 02/15/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1