BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTNAUTOBIPAPHUMCELL DOM

    MDR report key: 14104917 · Received April 12, 2022

    Report

    Report Number
    MW5108948
    Event Type
    Injury
    Date Received
    April 12, 2022
    Report Date
    April 10, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE EXPERIENCED THROAT IRRITATION SINCE MID 2021. IN (B)(6) 2021, MY ENT DOCTOR SCOPED MY THROAT AND REPORTED "NO CANCER" AND OFFERED NO TREATMENT. AS OF YET I HAVE NO RELIEF FROM THE ISSUE. FOR THE LAST FEW YEARS, I HAVE BEEN USING A RECALLED BIPAP DEVICE PRODUCED BY PHILIPS CORPORATIONS. I SLEPT WITH THIS OPERATING DEVICE ON A DAILY BASIS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786904 DREAMSTNAUTOBIPAPHUMCELL DOM VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Disability ASPIRIN 81 MG| B COMPLEX | BIPAP MACHINE| D3| DESVENLAFAXINE| FAMOTIDINE| LISINOPRIL | PRAZOSIN| ROSUVASTATIN | TAMSULOSIN | ZINC