BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYVASO INHALATION SYSTEM

    MDR report key: 3022796 · Received March 26, 2013

    Report

    Report Number
    MW5029478
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    March 6, 2013
    Manufacturer
    UT GMBH
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS CASE IS A SOLICITED REPORT FROM THE UNITED STATES REGARDING A REPORT RECEIVED FROM CONSUMER VIA A SPECIALTY PHARMACY. THE PT WAS A (B)(6) FEMALE WHO FIRST RECEIVED TYVASO (TREPROSTINIL) ON (B)(6) 2012 FOR PRIMARY PULMONARY HYPERTENSION. INHALED TREPROSTINIL DOSAGE WAS 18 TO 54 MICROGRAMS (MCG) (3 TO 9 BREATHS) WHEN THE PT REPORTED THAT, ON AN UNSPECIFIED DATE, SHE WAS MISSING A BAFFLE PLATE AND THAT IT PROBABLY HAD NOT BEEN IN PLACE FOR ONE WEEK. THIS CASE IS LINKED TO (B)(4) (NOT BEEN FEELING TOO WELL). MFR REPORT#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124364 TYVASO INHALATION SYSTEM NEBULIZER CAF UT GMBH ON-100/7

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other TYVASO