BEUDAMED
    FDA Adverse Event Other Summary report: N

    MYPURMIST

    MDR report key: 3805775 · Received May 6, 2014

    Report

    Report Number
    MW5036018
    Event Type
    Other
    Date Received
    May 6, 2014
    Date of Event
    November 1, 2013
    Report Date
    May 6, 2014
    Manufacturer
    VAPORE, LLC
    Product Code
    KFZ
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HAZARDOUS INCIDENT. MY PURMIST, HANDHELD STEAM INHALER REGISTERED TRADEMARKS AS FOLLOW, OWNED BY VAPORE, LLC. (B)(4). OTHER PATENTS PENDING WORLDWIDE. DESIGNED BY VAPORE IN (B)(4), ASSEMBLED IN (B)(4). THERE HAVE BEEN 5 UNITS. PURCHASED FROM: (B)(6) STORE. ONE OF 5 FAILED UNITS. PRODUCT WAS NOT DAMAGED. REPAIRED OR MODIFIED BEFORE THE INCIDENT. PLEASE NOTE VAPORE, LLC HAS 1 UNIT AND HAS NOT REFUNDED MONEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271139 MYPURMIST STEAM INHALER KFZ VAPORE, LLC CFV 100

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR MYPURFIL