MAUDE Adverse Event Report: IRRIMAX CORPORATION IRRISEPT; WOUND CLEANSER

Model Number	ISEPT-450-USA
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Damage to Ligament(s) (1952); Muscle Weakness/Atrophy (1967); Loss of Range of Motion (2032); Joint Dislocation (2374); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Irrimax is submitting this report in accordance with 21 cfr 803.This report is based upon information provided to irrimax.Irrimax will continue to contact reporting physician and other sources as necessary for the purpose of obtaining additional information and will, as necessary, file a follow-up 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.
Event or Problem Description
Right knee internal dehiscence of arthrotomy repair.
Additional Manufacturer Narrative
Irrimax is submitting this report in accordance with 21 cfr § 803.This report is based upon information provided to irrimax.Blank fields indicate that the information was not provided by physician reporting the event, was not available, or was not applicable.Irrimax has made multiple requests for medical records and has not received a response.Irrimax will continue to reach out and will file an additional follow-up report if new information is provided.This report does not constitute an admission to or conclusion by fda, irrimax, or its employees or agents that the device, irrimax, 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.
Event or Problem Description
Right knee internal dehiscence of arthrotomy repair.

• Brand Name: IRRISEPT
• Common Device Name: WOUND CLEANSER
• Manufacturer (Section D): IRRIMAX CORPORATION; 1665 lakes parkway; suite 102; lawrenceville GA 30043
• MDR Report Key: 11287802
• Report Number: 3005706359-2021-00003
• Device Sequence Number: 3440616
• Product Code: FRO
• UDI-Device Identifier: 10842351190002
• UDI-Public: 10842351190002
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K202222
• 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,Followup
• Report Date (Section B): 02/04/2021

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 Catalogue Number: 9000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 03/08/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 54