BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK

    MDR report key: 19176386 · Received April 24, 2024

    Report

    Report Number
    3012811961-2024-00007
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    March 26, 2024
    Report Date
    April 24, 2024
    Manufacturer
    ECOLAB/MICROTEK INC
    Product Code
    PUI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DRAPE HAS HOLE, LEAKED. NO PATIENT INJURIES, INFECTIONS OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427647 MICROTEK SLUSH + WARMER PLATE-DRAPE¿ PUI ECOLAB/MICROTEK INC ORS-331 3153LA6100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown