BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRRISEPT

    MDR report key: 5945345 · Received September 13, 2016

    Report

    Report Number
    3005706359-2016-00002
    Event Type
    Injury
    Date Received
    September 13, 2016
    Date of Event
    May 25, 2016
    Report Date
    June 14, 2016
    Manufacturer
    IRRIMAX CORPORATION
    Product Code
    FQH
    PMA / PMN Number
    K080779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS NOT FILED WITHIN THIRTY (30) DAYS OF BECOMING AWARE OF INFORMATION INCLUDED HEREIN DUE TO DELAYS IN THE EMDR REGISTRATION PROCESS. THIS REPORT WAS SUBMITTED AS SOON AS EMDR REGISTRATION WAS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS NOT FILED WITHIN THIRTY (30) DAYS OF BECOMING AWARE OF INFORMATION INCLUDED HEREIN DUE TO DELAYS IN THE EMDR REGISTRATION PROCESS. THIS REPORT WAS SUBMITTED AS SOON AS EMDR REGISTRATION WAS COMPLETE. IRRIMAX IS SUBMITTING THIS REPORT IN ACCORDANCE WITH 21C.F.R. § 803. THIS REPORT IS BASED UPON INFORMATION PROVIDED TO IRRIMAX, WHICH IRRIMAX MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THIS REPORT WAS SUBMITTED. IRRIMAX WILL CONTINUE TO CONTACT THE REPORTING PHYSICIAN FOR THE PURPOSE OF OBTAINING ADDITIONAL INFORMATION, TO THE EXTENT POSSIBLE, AND WILL TAKE STEPS TO IDENTIFY OTHER MISSING INFORMATION THAT WILL, TO THE EXTENT APPLICABLE, BE INCLUDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT IT WAS THE USE OF IRRISEPT DURING A PRIMARY TOTAL KNEE REPLACEMENT THAT MAY HAVE CAUSED KNEE PAIN AND WOUND DAMAGE. IT WAS REPORTED THAT THE PATIENT RETURNED TO THE EMERGENCY ROOM POSTOPERATIVE DAY 4 AND WAS DIAGNOSED WITH CELLULITIS IT WAS REPORTED THAT THE PATIENT UNDERWENT A REOPERATION. IT WAS REPORTED THAT THE REOPERATION WAS DONE WITH WASHOUT AND NOT THE DEVICE. ACCORDING TO INFORMATION PROVIDED TO IRRIMAX, SURGEON REPORTING THIS EVENT HAD ANOTHER PATIENT WITH KNEE PAIN AND WOUND DAMAGE WHO HAD UNDERGONE A PRIMARY TOTAL KNEE REPLACEMENT VISIT THE EMERGENCY ROOM ON THE SAME DAY AS THIS PATIENT (MFR REPORT# 3005706359-2016-00001).

    Description of Event or Problem · 1

    SURGEON REPORTED THAT IT WAS THE USE OF IRRISEPT DURING A PRIMARY TOTAL KNEE REPLACEMENT THAT MAY HAVE CAUSED KNEE PAIN AND WOUND DAMAGE. IT WAS REPORTED THAT THE PATIENT RETURNED TO THE EMERGENCY ROOM POSTOPERATIVE DAY 4 AND WAS DIAGNOSED WITH CELLULITIS. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REOPERATION. IT WAS REPORTED THAT THE REOPERATION WAS DONE WITH WASHOUT AND NOT THE DEVICE. ACCORDING TO INFORMATION PROVIDED TO IRRIMAX, SURGEON REPORTING THIS EVENT HAD ANOTHER PATIENT WITH KNEE PAIN AND WOUND DAMAGE WHO HAD UNDERGONE A PRIMARY TOTAL KNEE REPLACEMENT VISIT THE EMERGENCY ROOM ON THE SAME DAY AS THIS PATIENT (MFR REPORT# 3005706359-2016-0001).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598183 IRRISEPT WOUND CLEANSER FQH IRRIMAX CORPORATION 403 5P014

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization