BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCOURAGE DEVICE

    MDR report key: 11671692 · Received April 15, 2021

    Report

    Report Number
    3004961434-2021-00004
    Event Type
    Injury
    Date Received
    April 15, 2021
    Date of Event
    March 19, 2021
    Report Date
    August 6, 2021
    Manufacturer
    RESPIRATORY TECHNOLOGIES INC.
    Product Code
    BYI
    UDI-DI
    00841561102785
    PMA / PMN Number
    K051383
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN INCOURAGE DEVICE ALLEGEDLY CAUSED A HERNIA. REPEATED ATTEMPTS TO HAVE THE DEVICE RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN INCOURAGE DEVICE CAUSED A HERNIA. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569480 INCOURAGE DEVICE PERCUSSOR, POWERED-ELECTRIC BYI RESPIRATORY TECHNOLOGIES INC. R500055-000 00841561102785

    Patients

    Seq Age Sex Outcome Treatment
    1 Other