BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCOURAGE DEVICE

    MDR report key: 16709721 · Received April 10, 2023

    Report

    Report Number
    3004961434-2023-00001
    Event Type
    Injury
    Date Received
    April 10, 2023
    Date of Event
    March 16, 2023
    Report Date
    May 23, 2023
    Manufacturer
    RESPIRATORY TECHNOLOGIES, INC.
    Product Code
    BYI
    PMA / PMN Number
    K051383
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED THE INCOURAGE DEVICE ALLEGEDLY BROKE A PATIENT'S RIBS IN OCTOBER AND THE PATIENT HAS DISCONTINUED THERAPY. THERE WAS NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION CONTAMINATION WAS OBSERVED AND THE DEVICE WAS SCRAPPED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE INCOURAGE DEVICE BROKE A PATIENT'S RIBS IN OCTOBER AND THE PATIENT HAS DISCONTINUED THERAPY. THERE WAS NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED. 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
    1852517 INCOURAGE DEVICE PERCUSSOR, POWERED-ELECTRIC BYI RESPIRATORY TECHNOLOGIES, INC. R500055-000

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other