BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROAIR HFA

    MDR report key: 7171436 · Received January 5, 2018

    Report

    Report Number
    MW5074435
    Event Type
    Injury
    Date Received
    January 5, 2018
    Date of Event
    January 4, 2018
    Report Date
    January 5, 2018
    Manufacturer
    TEVA PHARMACEUTICAL
    Product Code
    KCO
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES THAT THE PROAIR PUMP WAS UNABLE TO DELIVER TREATMENT AS EXPECTED WHEN A (HER) CHILD WENT INTO RESPIRATORY DISTRESS YESTERDAY. ACCORDING TO REPORTER, SHE HAS USED HUNDREDS OF THIS PUMP WITH ALMOST SIMILAR MALFUNCTION WHICH MAKES HER THINK THE PRODUCT (PUMP) IS OF POOR QUALITY AND OF NO GOOD AND AS SUCH SHOULD BE TAKEN OFF THE MARKET. PER REPORTER, FDA NEEDS TO TAKE IMMEDIATE ACTION AGAINST THIS MANUFACTURER TO PREVENT WHAT HER CHILD EXPERIENCED FROM HAPPENING TO ANY OTHER CHILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14188 PROAIR HFA PUMP KCO TEVA PHARMACEUTICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening