BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRRISEPT ANTIMICROBIAL WOUND LAVAGE

    MDR report key: 12438312 · Received September 8, 2021

    Report

    Report Number
    12438312
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Date of Event
    August 25, 2021
    Report Date
    August 25, 2021
    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

    Narratives

    Description of Event or Problem · 1

    CIRCULATOR OPENED IRRISEPT PACKAGE ASEPTICALLY TO SCRUB TECH. SCRUB TECH OPENED OUTER WRAP AND HAIR WAS NOTED ON THE PROTECTIVE RING. SCRUB TECH PASSED IT BACK TO CIRCULATOR AND CHANGED OUTER GLOVES. HAIR SECURED TO PROTECTIVE RING WITH TAPE WHERE FOUND TO PREVENT LOSS. PACKAGING AND PRODUCT WITH HAIR SAVED FOR OR QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337917 IRRISEPT ANTIMICROBIAL WOUND LAVAGE LAVAGE, JET FQH IRRIMAX CORPORATION ISEPT-450-USA 21EDB762 00842351190005

    Patients

    Seq Age Sex Outcome Treatment
    1