BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLARA

    MDR report key: 19722244 · Received July 10, 2024

    Report

    Report Number
    MW5157206
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    July 3, 2024
    Report Date
    July 8, 2024
    Manufacturer
    HILL-ROM MANUFACTURING, INC.
    Product Code
    NHJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE VERY BAD LUNGS AND I AM GOING TO LUNG THERAPY AND USING THIS VOLARA MACHINE. WEDNESDAY, I USED IT AND WOKE UP IN THE NIGHT WITH HORRIBLE PAIN ON MY LEFT SIDE. IT IS A BROKEN RIB. I DIDN'T FALL OR DO ANYTHING THAT WOULD CAUSE THIS. SO, I'M THINKING THE LUNG EXPANSION FROM THIS MACHINE MAY HAVE CAUSED THIS. I HAD X-RAYS BUT MY LUNGS ARE SO BAD THEY COULDN'T TELL MUCH. I HAVE SARCOIDOSIS AND ASTHMA. I JUST WANTED TO LET YOU KNOW. THANK YOU! (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2386361 VOLARA DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT NHJ HILL-ROM MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Other ALBUTEROL.| TRELEGY.