BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOZEE

    MDR report key: 22059369 · Received May 21, 2025

    Report

    Report Number
    3010168054-2025-00003
    Event Type
    Injury
    Date Received
    May 21, 2025
    Date of Event
    April 17, 2025
    Report Date
    May 21, 2025
    Manufacturer
    JIANGMEN DACHENG MEDICAL EQUIPMENT CO., LTD.
    Product Code
    DWJ
    UDI-DI
    06951013002649
    PMA / PMN Number
    K231596
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GENTHERM MEDICAL, LLC., IS REPRESENTING THE MANUFACTURER AND IS SUBMITTING THIS REPORT ON THEIR BEHALF. COMPLAINT #(B)(4) RECEIVED BY GENTHERM MEDICAL, LLC., ON (B)(6) 2025.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS A BURN TO THE PATIENT'S SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885453 KOZEE KOZEE DWJ JIANGMEN DACHENG MEDICAL EQUIPMENT CO., LTD. M21507 06951013002649

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other