BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 22077806 · Received May 23, 2025

    Report

    Report Number
    2020813-2025-00003
    Event Type
    Injury
    Date Received
    May 23, 2025
    Date of Event
    March 27, 2025
    Report Date
    May 23, 2025
    Manufacturer
    ACCUTRON INC.
    Product Code
    BSZ
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE NOT RETURNED TO MANUFACTURER. DEVICE MODEL NUMBER AND SERIAL NUMBER NOT PROVIDED TO MANUFACTURER. ADVERSE EVENT CAUSE COULD NOT BE ESTABLISHED DUE TO LACK OF INFORMATION AND DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    DISTRIBUTOR REPORTED THAT A PATIENT WAS BURNED. UPPER LIP, CHEEK AND EYEBROW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2260973 UNKNOWN FLOWMETER BSZ ACCUTRON INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Other