BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWMETER, CM

    MDR report key: 22344897 · Received June 27, 2025

    Report

    Report Number
    2020813-2025-00004
    Event Type
    Injury
    Date Received
    June 27, 2025
    Date of Event
    June 4, 2025
    Report Date
    June 27, 2025
    Manufacturer
    ACCUTRON INC.
    Product Code
    BSZ
    UDI-DI
    00813830021141
    PMA / PMN Number
    K970163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FLOWMETER WAS RETURNED TO MANUFACTURER. MANUFACTURER COULD NOT DUPLICATE REPORTED PROBLEM. FLOWMETER MEETS SPECIFICATIONS.

    Description of Event or Problem · 0

    REPORT OF PATIENT GETTING SICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1814306 FLOWMETER, CM FLOWMETER BSZ ACCUTRON INC. 31970 00813830021141

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other