BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRRISEPT

    MDR report key: 10918973 · Received November 30, 2020

    Report

    Report Number
    10918973
    Event Type
    Malfunction
    Date Received
    November 30, 2020
    Date of Event
    October 1, 2020
    Report Date
    October 26, 2020
    Manufacturer
    IRRIMAX CORPORATION
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CONTAINERS INSIDE THE SEALED, UNDAMAGED PACKAGES WERE LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382550 IRRISEPT LAVAGE, JET FQH IRRIMAX CORPORATION ISEPT-450-USA

    Patients

    Seq Age Sex Outcome Treatment
    1