BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK

    MDR report key: 18916385 · Received March 15, 2024

    Report

    Report Number
    8043817-2024-00005
    Event Type
    Malfunction
    Date Received
    March 15, 2024
    Date of Event
    February 13, 2024
    Report Date
    March 15, 2024
    Manufacturer
    ECOLAB/MICROTEK INC
    Product Code
    PUI
    UDI-DI
    00748426107407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COVERS WERE STUCK TOGETHER AND BROKE WHEN USED. NO PATIENT INJURY, INFECTIONS OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130928 MICROTEK ADHESION GENERAL PURPOSE PROBE COVER PUI ECOLAB/MICROTEK INC APC1292 1482LRE200 00748426107407

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown