BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK

    MDR report key: 19706508 · Received July 9, 2024

    Report

    Report Number
    8043817-2024-00013
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Report Date
    July 9, 2024
    Manufacturer
    ECOLAB/MICROTEK INC
    Product Code
    PUI
    UDI-DI
    00748426107384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A MATEROVIGILANCE REPORT INDICATED THAT A CUSTOMER ENCOUNTERED THE SAME PROBLEM WITH REFERENCE (B)(4). IT WAS FROM THE SAME BATCH AS THE INCIDENT REPORTED IN APRIL COMP-(B)(4). THE ADHESIVE REMAINS ON THE LABEL INSTEAD OF ON THE PROBE COVER. TEST ON THREE DEVICES FROM THE SAME BATCH: SAME FINDING. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545810 MICROTEK ADHESION¿ GENERAL PURPOSE PROBE COVER PUI ECOLAB/MICROTEK INC APC1291 3253LR5700 00748426107384

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown