BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAZIC

    MDR report key: 18353295 · Received December 19, 2023

    Report

    Report Number
    8010890-2023-00001
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    February 9, 2023
    Report Date
    May 22, 2023
    Manufacturer
    PETER LAZIC GMBH MICROSURGICAL INNOVATIONS
    Product Code
    KAG
    UDI-DI
    04250603738718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE INCIDENT HAPPENED ON (B)(6) 2023. FEEDBACK THAT THE INCIDENT OCCURRED WAS RECEIVED BY PETER LAZIC GMBH ON (B)(6) 2023. THE INCIDENT HAPPENED IN A HOSPITAL IN GERMANY. THE HOSPITAL STATES THAT THE SPECULUM WAS INSERTED INTO THE RIGHT SIDE OF THE NOSE AND SPREAD OPEN. AFTER COMPLETION OF THE PROCEDURE, THE SPREADER COULD NOT BE TWISTED BACK TOGETHER, SO IT HAD TO BE REMOVED IN A WIDE OPEN STATE. THE HOSPITAL STATES THAT IT COULD HAVE LED TO A SERIOUS DETERIORATION OF THE PATIENT'S HEALTH. THE INVESTIGATION OF THE CAUSE IS ON-GOING. NO PATIENT DATA OR FURTHER DATA ON THE PROCEDURE ARE KNOWN. INTERNAL IDENTIFICATION NUMBER (B)(4) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2302226 LAZIC CUSHING-LANDOLT SPECULA KAG PETER LAZIC GMBH MICROSURGICAL INNOVATIONS 70.581.01 U043613 04250603738718

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown