BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRRISEPT

    MDR report key: 11309374 · Received February 10, 2021

    Report

    Report Number
    3005706359-2021-00004
    Event Type
    Injury
    Date Received
    February 10, 2021
    Report Date
    February 10, 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 · 1

    IRRIMAX IS SUBMITTING THIS REPORT IN ACCORDANCE WITH 21 CFR § 803. THIS REPORT IS BASED UPON INFORMATION PROVIDED TO IRRIMAX. THE NUMBER OF PATIENTS IS NOT KNOWN BY THE REPORTING PHYSICIAN. 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

    ACCORDING TO THE PHYSICIAN, THE WOUNDS OF SEVERAL PATIENTS APPEARED INFLAMED ALONG THE INCISIONAL LINE AND WERE RED, SOMEWHAT RAISED, AND HAD SMALL ANGIOMATOUS TYPE VESSELS GROWING FROM THE WOUND OUTWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203920 IRRISEPT WOUND CLEANSER FRO IRRIMAX CORPORATION ISEPT-450-USA 10842351190002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other