BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXUS 2

    MDR report key: 345893 · Received August 6, 2001

    Report

    Report Number
    2024312-2001-00001
    Event Type
    Injury
    Date Received
    August 6, 2001
    Date of Event
    July 6, 2001
    Report Date
    July 6, 2001
    Manufacturer
    KERR DENTAL MATERIALS CENTER
    Product Code
    EMA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED VIA A DENTIST WHO STATED THAT A PATIENT EXPERIENCED A BURNING SENSATION ON THEIR LIP AFTER HE PERFORMED A DENTAL PROCEDURE USING NEXUSZ. THE DENTIST SAW THE PATIENT 2 WEEKS FOLLOWING THE PROCEDURE AND OBSERVED A DARK PIGMENTATION ON THEIR LIP. THE DENTIST STATED THAT IT APPEARED TO BE A SCAR AND NOT TEMPORARY IN NATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35535 NEXUS 2 LUTING CEMENT EMA KERR DENTAL MATERIALS CENTER NA 101071

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other