BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK

    MDR report key: 18935770 · Received March 19, 2024

    Report

    Report Number
    8043817-2024-00006
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Report Date
    March 19, 2024
    Manufacturer
    ECOLAB/MICROTEK INC
    Product Code
    PUI
    UDI-DI
    00748426090204
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROBE COVER WAS PIERCED. NO PATIENT INJURY, INFECTIONS OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471737 MICROTEK GENERAL PURPOSE PROBE COVER PUI ECOLAB/MICROTEK INC GPC396EU D221041A 00748426090204

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown