BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCOURAGE DEVICE

    MDR report key: 14955045 · Received July 8, 2022

    Report

    Report Number
    3004961434-2022-00004
    Event Type
    Injury
    Date Received
    July 8, 2022
    Date of Event
    June 13, 2022
    Report Date
    March 31, 2023
    Manufacturer
    RESPIRATORY TECHNOLOGIES, INC.
    Product Code
    BYI
    PMA / PMN Number
    K051383
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN INCOURAGE DEVICE ALLEGEDLY CAUSED A PATIENT'S FUSION IN NECK TO HAVE BOTTOM SCREWS LOOSENED. THE PHYSICIAN INSTRUCTED THE PATIENT TO DISCONTINUE USE OF THE DEVICE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION. THE THIRD PARTY SERVICE CENTER FOUND THE DEVICE TO HAVE AN INTERMITTENT FUNCTIONAL ISSUE AND THE DEVICE WOULD AUTOMATICALLY RESTART. THE DEVICE WAS SCRAPPED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN INCOURAGE DEVICE CAUSED A PATIENT'S FUSION IN NECK TO HAVE BOTTOM SCREWS LOOSENED. THE PHYSICIAN INSTRUCTED THE PATIENT TO DISCONTINUE USE OF THE DEVICE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. 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
    1504333 INCOURAGE DEVICE PERCUSSOR, POWERED-ELECTRIC BYI RESPIRATORY TECHNOLOGIES, INC. R500055-000

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other