BEUDAMED
    FDA Adverse Event Other Summary report: N

    AEROLITE

    MDR report key: 78286 · Received March 21, 1997

    Report

    Report Number
    1931654-1997-00001
    Event Type
    Other
    Date Received
    March 21, 1997
    Date of Event
    February 17, 1997
    Report Date
    March 17, 1997
    Manufacturer
    MEDICAL INDUSTRIES AMERICA, INC.
    Product Code
    CAF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PER FOLLOW-UP TELEPHONE CONVERSATIONS WITH THE REPORTER, THE SUBJECT DEVICE, A 4003 PORTABLE COMPRESSOR NEBULIZER, BEGAN TO MELT DURING A TREATMENT AND THE PT ALLEGEDLY INHALED "TOXIC FUMES". NO OTHER INFO WAS MADE AVAILABLE AT THIS TIME CONCERNING THE PT. ACCORDING TO THE REPORTER, HIS CLIENT WENT TO THE ER AFTER HIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEROLITE PORTABLE COMPRESSOR NEBULIZER CAF MEDICAL INDUSTRIES AMERICA, INC. 4003 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other