BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYVASO INHALATION SYSTEM

    MDR report key: 3111711 · Received May 9, 2013

    Report

    Report Number
    MW5030134
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    May 2, 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

    ON AN UNK DATE, THE BATTERY SMELLED AND THEN LOOKED MELTED WITH SOMETHING LEAKING FROM IT. A REPLACEMENT BATTERY WAS SENT THE SAME DAY. THE OUTCOME WAS UNK. DEVICE MFR DATE: 11/2010. DATE REC'D BY MFR: (B)(4) 2013. (B)(4). INITIAL RPTR: CONSUMER, RPTR DETAILS WITHHELD, USA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204865 TYVASO INHALATION SYSTEM NEBULIZER CAF UT GMBH ON-100HPA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TYVASO