BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK

    MDR report key: 18848333 · Received March 6, 2024

    Report

    Report Number
    3012811961-2024-00004
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    January 11, 2024
    Report Date
    March 6, 2024
    Manufacturer
    ECOLAB/MICROTEK INC
    Product Code
    PUI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COMPONENT WAS DEFECTIVE, PROBE COVER BROKE DURING CASE. NO PATIENT INJURY, INFECTIONS OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145329 MICROTEK INTRAOPERATIVE PROBE COVER PUI ECOLAB/MICROTEK INC PC3787PAN D221259; 2053LA0600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown