BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRRISEPT

    MDR report key: 7096620 · Received December 7, 2017

    Report

    Report Number
    3005706359-2017-00002
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    August 14, 2017
    Report Date
    December 4, 2017
    Manufacturer
    IRRIMAX CORPORATION
    Product Code
    FQH
    UDI-DI
    10842351100032
    PMA / PMN Number
    K090779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 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.

    Description of Event or Problem · 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873964 IRRISEPT WOUND CLEANSER FQH IRRIMAX CORPORATION 403 SEE SECTION 10 BELOW 10842351100032

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention