BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUADIS 56

    MDR report key: 22673837 · Received July 31, 2025

    Report

    Report Number
    9616031-2025-0000006
    Event Type
    Injury
    Date Received
    July 31, 2025
    Date of Event
    July 16, 2025
    Report Date
    April 3, 2026
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    UDI-DI
    07340153710351
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    GETINGE HAS BEEN AWARE ABOUT A CHEMICAL ODOR FROM WASHER DISINFECTOR AQUADIS 56-SERIES, MODEL NAME 56M. THE ODOR LED TO HEALTH SYMPTOMS REPORTED BY STAFF INCLUDING COUGHING, SORE THROAT, AND BREATHING ISSUES. SEVERAL INDIVIDUALS REQUIRED MEDICAL TESTING AND TREATMENT. IN RESPONSE, THE UNIT WAS TAKEN OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514465 AQUADIS 56 DISINFECTOR, MEDICAL DEVICES MEC GETINGE DISINFECTION AB 56M 07340153710351

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other