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	Muscle Weakness/Atrophy (1967); Loss of Range of Motion (2032); Joint Dislocation (2374); Impaired Healing (2378)
Date of Event	12/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Irrimax is submitting this report in accordance with 21 cfr § 803.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
Left 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: 11367204
• Report Number: 3005706359-2021-00005
• Device Sequence Number: 16956008
• 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: K20222
• 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): 02/23/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Weight: 95