BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORMALIN

    MDR report key: 17660474 · Received August 31, 2023

    Report

    Report Number
    17660474
    Event Type
    Malfunction
    Date Received
    August 31, 2023
    Date of Event
    March 29, 2023
    Report Date
    August 11, 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

    SPECIMEN JAR IN THE PROCEDURE ROOM WAS NOTED TO HAVE A BLACK PARTICLE FLOATING IN IT. THE JAR WAS REMOVED FROM THE STOCK AND APSM NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190793 FORMALIN FORMALIN, NEUTRAL BUFFERED IFP E K INDUSTRIES, INC. 24499-100X60ML 2236109

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown