BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYVASO INHALATION SYSTEM

    MDR report key: 2732659 · Received September 6, 2012

    Report

    Report Number
    MW5026803
    Event Type
    Malfunction
    Date Received
    September 6, 2012
    Report Date
    August 28, 2012
    Manufacturer
    UT GMBH
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CONSUMER REPORTED THROUGH THE US SPECIALTY PHARMACY ((B)(4)) THAT THE BATTERY SPARKED WHEN PLUGGED IN. MFR DATE: 08/2010.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other