BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK

    MDR report key: 22916517 · Received August 28, 2025

    Report

    Report Number
    3012811961-2025-00008
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    July 29, 2025
    Report Date
    August 28, 2025
    Manufacturer
    MICROTEK MEDICAL LLC
    Product Code
    PUI
    UDI-DI
    00748426046362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THE PRODUCT BROKE IMMEDIATELY PRIOR TO USE. SPECIFICALLY, THE PROBE TIP DETACHED FROM THE DRAPE. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2188774 MICROTEK PROBE CVR INTRAOP 5X96IN STRT W-GEL PUI MICROTEK MEDICAL LLC PC3787 2434LA0800 00748426046362

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown