BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SICAT OPTIMOTION

    MDR report key: 11131483 · Received January 7, 2021

    Report

    Report Number
    3006098230-2021-00001
    Event Type
    Injury
    Date Received
    January 7, 2021
    Date of Event
    July 30, 2020
    Report Date
    March 5, 2021
    Manufacturer
    SICAT GMBH & CO. KG
    Product Code
    MQC
    PMA / PMN Number
    K143655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    A PATIENT EXPERIENCED REGULAR ALLERGIC REACTIONS (ANGIOEDEMA IN THE ORAL CAVITY) WHEN USING SICAT OPTIMOTION ORAL APPLIANCE. IN LATE (B)(6) 2020, HE ALSO WENT INTO RESPIRATORY DISTRESS AND HAD TO USE AN EPINEPHRINE AUTO-INJECTOR. FOLLOWING THIS EVENT THE GENERAL PRACTIONER CAME TO THE CONCLUSION THAT THE SICAT OPTIMOTION MIGHT BE CAUSING THE ALLEGIC REACTIONS. SICAT HAS BEEN MADE AWARE OF THE EVENT BY THE PATIENTS DENTIST ON (B)(6) 2020. EVALUATION REPORT / REPORT OF ANALYSIS IS ATTACHED (MDR-REPORT OF ANALYSIS-EVENT- ((B)(6)- (B)(6) 2020.PDF).

    Additional Manufacturer Narrative · 1

    A PATIENT EXPERIENCED REGULAR ALLERGIC REACTIONS (ANGIOEDEMA IN THE ORAL CAVITY) WHEN USING SICAT OPTIMOTION ORAL APPLIANCE. IN LATE (B)(6) 2020, HE ALSO WENT INTO RESPIRATORY DISTRESS AND HAD TO USE AN EPINEPHRINE AUTO-INJECTOR. FOLLOWING THIS EVENT THE GENERAL PRACTIONER CAME TO THE CONCLUSION THAT THE SICAT OPTIMOTION MIGHT BE CAUSING THE ALLEGIC REACTIONS. SICAT HAS BEEN MADE AWARE OF THE EVENT BY THE PATIENTS DENTIST ON 2020-12-11.

    Description of Event or Problem · 1

    A PATIENT EXPERIENCED REGULAR ALLERGIC REACTIONS (ANGIOEDEMA IN THE ORAL CAVITY) WHEN USING SICAT OPTIMOTION ORAL APPLIANCE. IN LATE (B)(6) 2020, HE ALSO WENT INTO RESPIRATORY DISTRESS AND HAD TO USE AN EPINEPHRINE AUTO-INJECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26532 SICAT OPTIMOTION ORAL APPLIANCE MQC SICAT GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening