BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESOURCE LACERATION TRAY

    MDR report key: 23053734 · Received September 15, 2025

    Report

    Report Number
    MW5176071
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    September 8, 2025
    Report Date
    September 10, 2025
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    OJV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE OMFS RESIDENT WAS FINISHING REPAIRING A LACERATION INSIDE THE PATIENT'S CHEEK, THE NEEDLE HOLDER FELL APART. THE PATIENT WAS NOT OTHERWISE INJURED FROM THE PRODUCT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2681443 PRESOURCE LACERATION TRAY SINGLE USE INSTRUMENT TRAY OJV CARDINAL HEALTH 200, LLC 555407

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Female