BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORMALIN CONTAINER 60ML

    MDR report key: 18169633 · Received November 20, 2023

    Report

    Report Number
    18169633
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    July 3, 2023
    Report Date
    September 26, 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

    FORMALIN CONTAINER FOUND WITH BROKEN LID. ALMOST ENTIRE PLASTIC CIRCLE IN CENTER OF LID BROKEN. MANUFACTURER RESPONSE FOR 60ML CONTAINER, 60ML CONTAINER (PER SITE REPORTER). MFG ACKNOWLEDGED THEY WOULD LOOK INTO IT AND FIX, FAILED TO FIX. WE ARE CONVERTING TO A MEDLINE PRODUCT DUE TO ONGOING ISSUES SINCE [REDACTED DATE].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1577878 FORMALIN CONTAINER 60ML FORMALIN, NEUTRAL BUFFERED IFP E K INDUSTRIES, INC. 24499-100X60ML 2215441

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown