BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPREDIA

    MDR report key: 24268549 · Received February 5, 2026

    Report

    Report Number
    24268549
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    January 8, 2026
    Report Date
    January 30, 2026
    Manufacturer
    RICHARD-ALLAN SCIENTIFIC COMPANY
    Product Code
    IFP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    CRACKED LID ON THE FORMALIN CONTAINER. THIS WAS FOUND IN THE FORMALIN BIN IN THE CSC OPERATING ROOM [COMPREHENSIVE STROKE CENTER OPERATING ROOM] CORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29558 EPREDIA FORMALIN, NEUTRAL BUFFERED IFP RICHARD-ALLAN SCIENTIFIC COMPANY 10% NEUTRAL BUFFERED FORMALIN PREFILLED CONTAINER

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown