MAUDE Adverse Event Report: IRRIMAX CORPORATION IRRISEPT; WOUND CLEANSER

Model Number	403
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthralgia (2355); Joint Swelling (2356)
Date of Event	08/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Irrimax is submitting this report in accordance with 21 cfr § 803.Irrimax identified and evaluated possible lot #s and found no issues.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.
Event or Problem Description
Physician reported that patient underwent a primary left total knee arthroplasty (tka) 22 years ago.Physician reported that patient underwent a revision for the left tka for implant loosening on (b)(6) 2017.Irrisept was used.Physician reported that patient underwent a tka revision including poly exchange on (b)(6) 2017 to address swelling.Irrisept was used and the physician reported that there was no infection.Physician reported that patient underwent another tka revision with synovectomy on (b)(6) 2017 including poly exchange and that patient had a reaction to chrloraprep (chlorhexidine) skin prep prior to incision.Physician reported irrisept was used for irrigation.Physician reported that patient received standard treatment with antibiotics 24 hours post-operatively.Physician reported patient underwent left knee scope with synovectomy on (b)(6) 2017 to address swelling and pain.Physician reported that patient was prepped with povidone iodine, that irrisept was not used, and that there were no signs of infection.Physician reported that patient likely developed hypersensitivity to chg in all forms and concentrations.

• Brand Name: IRRISEPT
• Common Device Name: WOUND CLEANSER
• Manufacturer (Section D): IRRIMAX CORPORATION; 1665 lakes parkway; suite 102; lawrenceville GA 30043
• MDR Report Key: 7096620
• Report Number: 3005706359-2017-00002
• Device Sequence Number: 1483438
• Product Code: FQH
• UDI-Device Identifier: 10842351100032
• UDI-Public: 10842351100032
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K090779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2017

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: 403
• Device Catalogue Number: IRRISEPT 403
• Device Lot Number: SEE SECTION 10 BELOW
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 104