BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVENT SLEEP THERAPY

    MDR report key: 6534628 · Received May 1, 2017

    Report

    Report Number
    3011683122-2017-00001
    Event Type
    Malfunction
    Date Received
    May 1, 2017
    Date of Event
    May 1, 2016
    Report Date
    May 1, 2017
    Manufacturer
    PROVENT SLEEP THERAPY, LLC
    Product Code
    OHP
    PMA / PMN Number
    K102404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS MANUFACTURED TO SPECIFICATION. NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    USER NOTICED THE VALVE FLAPS MISSING FROM THE DEVICE UPON WAKING IN THE MORNING. IT IS UNKNOWN WHETHER THE DEVICE WAS DEFECTIVE BEFORE USE OR IF THE FLAPS DETACHED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314664 PROVENT SLEEP THERAPY PROVENT 30 NIGHT STARTER KIT OHP PROVENT SLEEP THERAPY, LLC CAT1114 34061-S07

    Patients

    Seq Age Sex Outcome Treatment
    1