BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRRISEPT

    MDR report key: 11287802 · Received February 5, 2021

    Report

    Report Number
    3005706359-2021-00003
    Event Type
    Injury
    Date Received
    February 5, 2021
    Report Date
    February 4, 2021
    Manufacturer
    IRRIMAX CORPORATION
    Product Code
    FRO
    UDI-DI
    10842351190002
    PMA / PMN Number
    K202222
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IRRIMAX IS SUBMITTING THIS REPORT IN ACCORDANCE WITH 21 CFR § 803. THIS REPORT IS BASED UPON INFORMATION PROVIDED TO IRRIMAX. BLANK FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED BY PHYSICIAN REPORTING THE EVENT, WAS NOT AVAILABLE, OR WAS NOT APPLICABLE. IRRIMAX HAS MADE MULTIPLE REQUESTS FOR MEDICAL RECORDS AND HAS NOT RECEIVED A RESPONSE. IRRIMAX WILL CONTINUE TO REACH OUT AND WILL FILE AN ADDITIONAL FOLLOW-UP REPORT IF NEW INFORMATION IS PROVIDED. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION TO OR CONCLUSION BY FDA, IRRIMAX, OR ITS EMPLOYEES OR AGENTS THAT THE DEVICE, IRRIMAX, OR ITS EMPLOYEES OR AGENTS CAUSED, CONTRIBUTED IN ANY WAY TO, OR ANY WAY IS CONNECTED WITH THE EVENT(S) DESCRIBED IN THIS 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.

    Description of Event or Problem · 0

    RIGHT KNEE INTERNAL DEHISCENCE OF ARTHROTOMY REPAIR.

    Additional Manufacturer Narrative · 1

    IRRIMAX IS SUBMITTING THIS REPORT IN ACCORDANCE WITH 21 CFR 803. THIS REPORT IS BASED UPON INFORMATION PROVIDED TO IRRIMAX. 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.

    Description of Event or Problem · 1

    RIGHT KNEE INTERNAL DEHISCENCE OF ARTHROTOMY REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183468 IRRISEPT WOUND CLEANSER FRO IRRIMAX CORPORATION ISEPT-450-USA 10842351190002

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| R