BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAZ INC

    MDR report key: 128558 · Received October 24, 1997

    Report

    Report Number
    1314800-1997-90009
    Event Type
    Injury
    Date Received
    October 24, 1997
    Date of Event
    September 27, 1997
    Report Date
    October 23, 1997
    Manufacturer
    KAZ, INC.
    Product Code
    KFZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CO RECEIVED A CONSUMER COMPLAINT FROM PHARMACY REGARDING CUSTOMER GETTING BURNED BY THE STEM INHALER. THE CONSUMER CLAIMED THE PRODUCT "BLEW UP" IN PT'S FACE CAUSING THE WATER TO SCALD PT. DURING QUESTIONING BY THE PHARMACY IT WAS REVEALED THAT THE CONSUMER ADDED THE INHALANT TO THE WATER CONTRARY TO CO'S INSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAZ INC STEM INHALER KFZ KAZ, INC. 11SI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention