BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK

    MDR report key: 22856716 · Received August 20, 2025

    Report

    Report Number
    8043817-2025-00005
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Report Date
    August 20, 2025
    Manufacturer
    MICROTEK MEDICAL LLC
    Product Code
    PUI
    UDI-DI
    00748426107407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    ADHESIVE ISSUES WERE REPORTED IN THE PROBE COVERS. THEY ARE PARTIALLY STICKY AND CAUSE A TEAR IN THE PROBE COVER. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1727095 MICROTEK PROBE CVR GEN PURP 6X96IN ADHESION PUI MICROTEK MEDICAL LLC APC1292 3135LRP800 00748426107407

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown