BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAVER-VISITEC

    MDR report key: 17367401 · Received July 20, 2023

    Report

    Report Number
    3014527682-2023-00008
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    June 29, 2023
    Report Date
    July 20, 2023
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL INC
    Product Code
    HOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A FOREIGN SUBSTANCE NOTED IN SURGICAL FIELD. SURGEONS BELIEVE IT IS COMING OFF THE EYE SPEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1715923 BEAVER-VISITEC EYE SPEARS 10PK HOZ BEAVER-VISITEC INTERNATIONAL INC 0008686 22E1727;22H2631

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown