BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE REGULAR SET

    MDR report key: 7916384 · Received September 27, 2018

    Report

    Report Number
    8020994-2018-00001
    Event Type
    Injury
    Date Received
    September 27, 2018
    Date of Event
    August 24, 2018
    Report Date
    September 27, 2018
    Manufacturer
    KERR ITALIA S.R.L.
    Product Code
    EJK
    PMA / PMN Number
    K150559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY THE COMPLAINANT THAT LIFE BASE WAS USED AS A PRESSURE INDICATION PASTE TO IDENTIFY AREAS OF OVER EXTENSION ON AN ACRYLIC DENTURE COMPLAINANT IS AWARE THAT THIS IS NOT THE STANDARD APPLICATION. NO PATIENT INFORMATION WAS PROVIDED IN REGARDS TO WEIGHT, ETHNICITY, AND RACE.

    Description of Event or Problem · 1

    A COMPLAINANT ALLEGED THAT PATIENT EXPERIENCED THROBBING AND TIGHTNESS PARTICULARLY ON THE LEFT ANTERIOR MAXILLA. PATIENT NOTICED SWELLING OF THE UPPER AND LOWER LIP AS WELL AS TONGUE. PATIENT ALSO HAD A LEFT EAR ACHE. THE PAIN EXTENDED TO THE INFRAORBITAL REGION AND THERE WAS SOME MILD PERIORBITAL SWELLING AS WELL AS WATERING OF THE EYE. THIS CONTINUED TO PROGRESS TO A SORE THROAT. PATIENT WENT TO THE HOSPITAL DUE TO THE CONTINUED SYMPTOMS. PATIENT WAS DIAGNOSED WITH EXPERIENCING AN ALLERGIC REACTION, BUT NO TREATMENT WAS REQUIRED. THE SWELLING STARTED TO REDUCE, HOWEVER THERE ARE TWO AREAS OF ULCERATION PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755753 LIFE REGULAR SET LIFE FAST SET, LIFE REGULAR SET EJK KERR ITALIA S.R.L. 6456795

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other