BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRRISEPT ANTIMICROBIAL WOUND LAVAGE

    MDR report key: 16495009 · Received March 7, 2023

    Report

    Report Number
    16495009
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    February 8, 2023
    Report Date
    February 15, 2023
    Manufacturer
    IRRIMAX CORPORATION
    Product Code
    FQH
    UDI-DI
    00842351190005
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BOTTLE LEAKING PRIOR TO OPENING, THIS WAS FOUND PRIOR TO OPENING, BOTTLE NOT USED OR PRESENTED TO STERILE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139782 IRRISEPT ANTIMICROBIAL WOUND LAVAGE LAVAGE, JET FQH IRRIMAX CORPORATION ISEPT-450-USA 22K 00842351190005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown