BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIVIEW

    MDR report key: 9206083 · Received October 18, 2019

    Report

    Report Number
    8031023-2019-00002
    Event Type
    Injury
    Date Received
    October 18, 2019
    Report Date
    October 17, 2019
    Manufacturer
    KERR HAWE S.A
    Product Code
    EIG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT EXPERIENCED SYMPTOMS OF PAIN, BURNING DISCOMFORT, SWOLLEN LIPS. PATIENT WAS RECOMMENDED TO THE EMERGENCY ROOM AND RECEIVED ORAL STEROID AS WELL AS ANTIHISTAMINE. AFTER ONE WEEK, SWELLING DISAPPEARED. SPECIFIC PATIENT INFORMATION WITH REGARDS TO ETHNICITY, RACE AND WEIGHT WAS NOT PROVIDED. NO LOT NUMBER WAS PROVIDED THEREFORE MANUFACTURE DATE CANNOT BE DETERMINED. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A COMPLAINANT ALLEGED THAT TWO (2) PATIENTS EXPERIENCED AN ALLERGIC REACTION RESULTING IN SWELLINGS, BURNING AND PAIN IN LIPS. THIS IS THE SECOND OF TWO REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000788 OPTIVIEW LIP AND CHEEK RETRACTOR EIG KERR HAWE S.A

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other| R