BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCOURAGE DEVICE

    MDR report key: 15879480 · Received November 29, 2022

    Report

    Report Number
    3004961434-2022-00007
    Event Type
    Injury
    Date Received
    November 29, 2022
    Date of Event
    October 31, 2022
    Report Date
    November 29, 2022
    Manufacturer
    RESPIRATORY TECHNOLOGIES, INC.
    Product Code
    BYI
    UDI-DI
    00841561102785
    PMA / PMN Number
    K051383
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN INCOURAGE DEVICE CAUSED THE PATIENT TO HAVE PAIN IN HER RIGHT SIDE. THERE WAS NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2535985 INCOURAGE DEVICE PERCUSSOR, POWERED-ELECTRIC BYI RESPIRATORY TECHNOLOGIES, INC. 500055-000 00841561102785

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other