BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREFILLED FORMALIN CONTAINER 60 ML FILL IN 120 ML (4 OZ.)

    MDR report key: 15191758 · Received August 9, 2022

    Report

    Report Number
    15191758
    Event Type
    Malfunction
    Date Received
    August 9, 2022
    Date of Event
    June 15, 2022
    Report Date
    July 5, 2022
    Manufacturer
    E K INDUSTRIES, INC.
    Product Code
    IFP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UNPACKING NEW FORMALIN BOX AND NOTICED EMPTY FORMALIN BOTTLE, WHICH WAS CRACKED BUT BOX WAS DRY BOTTOM. LOT NUMBER 2207503. EXPIRY: YEAR 2024. BRAND EKI 120ML BOTTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1989228 PREFILLED FORMALIN CONTAINER 60 ML FILL IN 120 ML (4 OZ.) FORMALIN, NEUTRAL BUFFERED IFP E K INDUSTRIES, INC. 24499-100X120ML 2207503

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown