BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUVEIN AV500

    MDR report key: 14236335 · Received April 27, 2022

    Report

    Report Number
    MW5109410
    Event Type
    Malfunction
    Date Received
    April 27, 2022
    Report Date
    April 26, 2022
    Manufacturer
    ACCUVEIN INC.
    Product Code
    KZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE DEVICE CLAIMS TO SEE VEINS AT 10MM DEPTH WITHOUT SUPPORTING DATA. THE DEVICE MAKES A CLAIM THAT ISN'T SUPPORTED BY DATA. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109756 ACCUVEIN AV500 DEVICE, VEIN LOCATION, LIQUID CRYSTAL KZA ACCUVEIN INC. AV500

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose