BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRRISEPT

    MDR report key: 11475186 · Received March 12, 2021

    Report

    Report Number
    3005706359-2021-00007
    Event Type
    Injury
    Date Received
    March 12, 2021
    Date of Event
    January 29, 2021
    Report Date
    March 12, 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. IRRIMAX WILL CONTINUE TO CONTACT REPORTING PHYSICIAN AND OTHER SOURCES AS NECESSARY FOR THE PURPOSE OF OBTAINING ADDITIONAL INFORMATION AND WILL, IF NECESSARY, FILE A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    RIGHT KNEE (INTERNAL DEHISCENCE OF ARTHROTOMY REPAIR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373790 IRRISEPT WOUND CLEANSER FRO IRRIMAX CORPORATION ISEPT-450-USA 10842351190002

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other