BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECOLAB HUSH SLUSH 2.0 SLUSH & WARMER DISC-DRAPE

    MDR report key: 23084857 · Received September 18, 2025

    Report

    Report Number
    MW5176236
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    August 18, 2025
    Report Date
    September 15, 2025
    Manufacturer
    MICROTEK MEDICAL LLC
    Product Code
    PUI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AT THE END OF THE PROCEDURE WE NOTICED FLUID COLLECTION ON THE WARMER SIDE OF THE DRAPE. UPON INSPECTION OF THE DRAPE WE NOTICED THERE WAS A PORTION OF DRAPE THAT LOOKED LIKE IT HAD MELTED/THINNED OUT. WAS NOT NOTICED WHEN WE SETUP FOR THE CASE AT THE BEGINNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317588 ECOLAB HUSH SLUSH 2.0 SLUSH & WARMER DISC-DRAPE DRAPE, SURGICAL, EXEMPT PUI MICROTEK MEDICAL LLC 1484LA0100

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male