BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK MEDICAL INC.

    MDR report key: 12623961 · Received October 13, 2021

    Report

    Report Number
    8043817-2021-00005
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    April 19, 2021
    Report Date
    October 13, 2021
    Manufacturer
    ECOLAB/MICROTEK MEDICAL INC.
    Product Code
    PUI
    UDI-DI
    50748426053952
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE PROBE COVER SHREDDED WHEN IT WAS REMOVED FROM THE PACKAGE AND A HOLE WAS OBSERVED WHEN ATTEMPTING TO APPLY IT ON THE PROBE. NO INFECTION OR PATIENT INJURY OR INFECTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1521700 MICROTEK MEDICAL INC. PROBE COVER PUI ECOLAB/MICROTEK MEDICAL INC. PC0906NS D181691 50748426053952

    Patients

    Seq Age Sex Outcome Treatment
    1