BEUDAMED
    FDA Adverse Event Other Summary report: N

    AERONEB CO

    MDR report key: 562572 · Received December 28, 2004

    Report

    Report Number
    1931654-2004-00001
    Event Type
    Other
    Date Received
    December 28, 2004
    Date of Event
    November 5, 2004
    Report Date
    November 29, 2004
    Manufacturer
    MEDICAL INDUSTRIES AMERICA, INC.
    Product Code
    CAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 11/04, CONTACT OF THE SHIPPING DEPARTMENT FOR HOME OXYGEN CONTACTED MEDICAL INDUSTRIES AMERICA'S CUSTOMER CARE SPECIALIST. UPON QUESTIONING, CONTACT STATED THAT A CUSTOMER HAD BEEN AT A STORE WHEN THEY FELT THE ONSET OF SOME SORT OF ATTACK. CONTACT THOUGHT THAT THE AERONEB GO MAY HAVE FAILED WHEN THE CUSTOMER HAD TRIED TO USE IT. CONTACT INDICATED THAT THE CUSTOMER HAD GONE TO THE HOSP. IN 12/04 CO RECEIVED ADDITIONAL INFO FROM THE HOME OXYGEN CO CONCERNING THE UNIT IN QUESTION. HOME OXYGEN CO IDENTIFIED THE DEVICE WITH THEIR S/N. THE DEVICE HAD ABC PACKAGING LOT NUMBER 092904, ASSEMBLY LOT NUMBER 040520 AND MICROPUMP S/N. DESPITE NUMEROUS ATTEMPTS CO HAS NOT BEEN ABLE TO RECEIVE ANY ADDITIONAL INFO FROM HOME OXYGEN CO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AERONEB CO MICROPUMP NEBULIZER CAF MEDICAL INDUSTRIES AMERICA, INC. 7000 092904

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization