BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE AC/DC SUCTION MACHINE

    MDR report key: 16689225 · Received April 6, 2023

    Report

    Report Number
    3006446479-2023-00001
    Event Type
    Malfunction
    Date Received
    April 6, 2023
    Report Date
    March 13, 2023
    Manufacturer
    VEGA TECHNOLOGIES / DICKSON ASIA GROUP, LTD.
    Product Code
    LRQ
    UDI-DI
    00848530088965
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT REPORTED ONE UNIT OF SU100DC THAT STARTED SMOKING WHILE USING THE UNIT. NO REPORT OF INJURY WAS RECEIVED. EVIDENCE SHOWS THAT THE UNIT BURNT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1853618 PORTABLE AC/DC SUCTION MACHINE SUCTION MACHINE LRQ VEGA TECHNOLOGIES / DICKSON ASIA GROUP, LTD. SU100DC 00848530088965

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown