BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK

    MDR report key: 19019028 · Received April 2, 2024

    Report

    Report Number
    8043817-2024-00007
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Date of Event
    March 5, 2024
    Report Date
    April 2, 2024
    Manufacturer
    ECOLAB/MICROTEK INC
    Product Code
    PUI
    UDI-DI
    00748426107360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE "THE LITTLE STICKER ON THE ADHESIVE STRIP CANNOT BE REMOVED. THE SMALL ADHESIVE SQUARE ON THE WHITE ADHESIVE STRIP (ADHESIVE STRIP LABELED MICROTEK ECOLAB ADHESION ) THE SECOND DRAWING ON THE COVER UNABLE TO REMOVE ADHESIVE FROM SURFACE". NO PATIENT INJURY, INFECTIONS OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051555 MICROTEK ADHESIVE GENERAL PURPOSE PROBE COVER PUI ECOLAB/MICROTEK INC APC1289 3303LR9200 00748426107360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown