| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | IRRISEPT | WOUND CLEANSER | IRRIMAX CORPORATION | FQH | 403 | IRRISEPT 403 | SEE SECTION 10 BELOW | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-12-07 | 0 | 1. R |
Patient 1
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.
Patient 1
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.