BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    18081

    MDR report key: 20585205 · Received November 1, 2024

    Report

    Report Number
    3003188183-2024-90005
    Event Type
    Malfunction
    Date Received
    November 1, 2024
    Manufacturer
    VEGA TECHNOLOGIES INC.
    Product Code
    CAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    VEGA FOUND THE MDR REPORT ON THE FDA WEBSITE AS ATTACHMENT 1 MDR NO. (B)(4). MDR REPORT CONTENTS. IMMEDIATELY PULLED THE POWER CORD AND THREW THE NEBULIZER OUT THE DOOR." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE. NG QTY: (B)(4) PCS.

    Description of Event or Problem · 0

    VEGA FOUND THE MDR REPORT ON THE FDA WEBSITE AS ATTACHMENT 1 MDR NO. 2438477-2022-00069 MDR REPORT CONTENTS[?]IMMEDIATELY PULLED THE POWER CORD AND THREW THE NEBULIZER OUT THE DOOR." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENTASSOCIATED WITH THE COMPLAINT. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILEAN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE. NG Q'TY:1PCS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1930017 18081 NEBULIZER CAF VEGA TECHNOLOGIES INC. 18081

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown