BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCOURAGE SYSTEM

    MDR report key: 8116948 · Received November 29, 2018

    Report

    Report Number
    3004961434-2018-00003
    Event Type
    Injury
    Date Received
    November 29, 2018
    Date of Event
    November 3, 2018
    Report Date
    November 4, 2018
    Manufacturer
    RESPIRATORY TECHNOLOGIES INC.
    Product Code
    BYI
    PMA / PMN Number
    K051383
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    117

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED PERSISTENT ABDOMINAL DISCOMFORT. CT SCAN NOTED LARGE ABDOMINAL RECTUS SHEATH HEMATOMA. ATTENDING PHYSICIAN STATED THE PATIENT WAS VERY FRAIL AND BELIEVES THAT THE COMBINATION OF BLOOD THINNERS AND THE VIBRATIONS FROM THE VEST MAY HAVE BEEN THE CONTRIBUTING CAUSES OF THE HEMATOMA. PATIENT HAD NO LONG TERM NEGATIVE CONSEQUENCES FROM THE HEMATOMA AND IT IS LEFT TO RESOLVE ON ITS OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954464 INCOURAGE SYSTEM PULSATING VEST THERAPY BYI RESPIRATORY TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization