BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAM STATION AUTO CPAP

    MDR report key: 12066737 · Received June 24, 2021

    Report

    Report Number
    MW5102141
    Event Type
    Injury
    Date Received
    June 24, 2021
    Date of Event
    April 14, 2021
    Report Date
    June 22, 2021
    Manufacturer
    PHILLIPS / RESPIRONICS INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DEVELOPED CHRONIC URTICARIA IN (B)(6) 2021 THAT CONTINUES AT THIS WRITING. CURRENTLY SEEING DERMATOLOGIST WHO HAS, AFTER OTHER FAILED MEDICATIONS TO CONTROL THIS ILLNESS, PRESCRIBE MYCOPHENOLATE AT MAXIMUM DOSAGE TWICE A DAY AND REFERRED ME TO SPECIALIST FOR CONSULT WHICH IS STILL PENDING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954210 DREAM STATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS / RESPIRONICS INC. DSX500H11C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other| S