BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK

    MDR report key: 22512833 · Received July 15, 2025

    Report

    Report Number
    8043817-2025-00003
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Report Date
    July 15, 2025
    Manufacturer
    MICROTEK MEDICAL LLC
    Product Code
    PUI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE POBE COVER HAD HOLES. NO PATIENT INJURIES, INFECTIONS OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146346 MICROTEK PROBE COVER INTRAOPERATIVE PUI MICROTEK MEDICAL LLC PC1308N 2053LR0300

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown