BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRRISEPT

    MDR report key: 7861330 · Received September 10, 2018

    Report

    Report Number
    3005706359-2018-00001
    Event Type
    Injury
    Date Received
    September 10, 2018
    Date of Event
    July 26, 2018
    Report Date
    September 6, 2018
    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. 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 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

    PATIENT EXPERIENCED EKG CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703598 IRRISEPT WOUND CLEANSER FQH IRRIMAX CORPORATION 403 10842351100032

    Patients

    Seq Age Sex Outcome Treatment
    1 Other