BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORMALIN CONTAINER

    MDR report key: 17236722 · Received June 30, 2023

    Report

    Report Number
    17236722
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    February 14, 2023
    Report Date
    June 21, 2023
    Manufacturer
    E K INDUSTRIES, INC.
    Product Code
    IFP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EKI 10% FORMALIN FIXATIVE 60ML, LOT# 2236109, EXP# [REDACTED DATE] UNUSED BOTTLE HAD THINGS IN THE FORMALIN BOTTLE. MANUFACTURER RESPONSE FOR FORMALIN CONTAINER, FORMALIN CONTAINER (PER SITE REPORTER). ONGOING ISSUE AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750013 FORMALIN CONTAINER FORMALIN, NEUTRAL BUFFERED IFP E K INDUSTRIES, INC. 4499100X60ML 2236109

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown