BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET-EASE

    MDR report key: 24708599 · Received March 30, 2026

    Report

    Report Number
    24708599
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    February 3, 2026
    Report Date
    March 11, 2026
    Manufacturer
    INTERNATIONAL BIOMEDICAL, LTD.
    Product Code
    KYX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MOLD WAS DISCOVERED FLOATING IN A CONTAINER OF SWEET-EASE. ABOUT 0.1 -0.2ML OF SWEET EASE WAS ADMINISTERED PRIOR TO DISCOVERY. THERE WAS NO OBVIOUS PUNCTURES OR HOLES IN THE PRODUCT BUT UPON CLOSE INSPECTION AFTER DISCOVERY THE FOIL ON TO MAY NOT HAVE BEEN FULLY APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234745 SWEET-EASE SUCROSE SOLUTION KYX INTERNATIONAL BIOMEDICAL, LTD. 99044 25275

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other