BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIMAX

    MDR report key: 15272615 · Received August 23, 2022

    Report

    Report Number
    2518417-2022-00001
    Event Type
    Injury
    Date Received
    August 23, 2022
    Report Date
    August 22, 2022
    Manufacturer
    BOEHRINGER LABORATORIES, LLC
    Product Code
    FCZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A USER FACILITY WAS UNHAPPY WITH BOEHRINGER LABORATORIES VISIMAX AFTER EXPERIENCE IN ONE CASE WHERE VISIMAX WAS IN USE AND A SURGERY WAS CONVERTED FROM LAPAROSCOPIC TO OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2494098 VISIMAX SURGICAL SMOKE REMOVAL SYSTEM FCZ BOEHRINGER LABORATORIES, LLC 5700 21J

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization