BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCOURAGE DEVICE

    MDR report key: 11706015 · Received April 22, 2021

    Report

    Report Number
    3004961434-2021-00005
    Event Type
    Injury
    Date Received
    April 22, 2021
    Date of Event
    March 13, 2021
    Report Date
    May 14, 2021
    Manufacturer
    RESPIRATORY TECHNOLOGIES INC.
    Product Code
    BYI
    UDI-DI
    00841561102785
    PMA / PMN Number
    K051383
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN ENCOURAGE DEVICE CAUSED DEBILITATING CRAMPING. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED. THE DEVICE PASSED ALL TESTING AND OPERATED AS DESIGNED.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN INCOURAGE DEVICE CAUSED DEBILITATING CRAMPING. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. 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
    606932 INCOURAGE DEVICE PERCUSSOR, POWERED-ELECTRIC BYI RESPIRATORY TECHNOLOGIES INC. R500055-000 00841561102785

    Patients

    Seq Age Sex Outcome Treatment
    1 Other