BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXATIVE, FORMALIN

    MDR report key: 12951899 · Received December 7, 2021

    Report

    Report Number
    12951899
    Event Type
    Malfunction
    Date Received
    December 7, 2021
    Date of Event
    November 9, 2021
    Report Date
    November 16, 2021
    Manufacturer
    E K INDUSTRIES, INC.
    Product Code
    IGG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BLACK SPECK NOTED FLOATING IN SPECIMEN CONTAINER. UPON CLOSER INSPECTION APPEARS TO BE A DEAD BUG NOTED IN 10% FORMALIN FIXATIVE SPECIMEN CONTAINER. MANUFACTURER RESPONSE FOR FORMALIN SPECIMEN CONTAINER, FIXATIVE, FORMALIN 10PCT, 60ML PREFILL (PER SITE REPORTER): (B)(4) DISTRIBUTOR IS FACILITATING THE COMMUNICATION. CLINICAL SITE FILLED OUT THE PRODUCT COMPLAINT FORM. AWAITING INSTRUCTIONS TO RETURN. PICTURES SENT TO THE REPRESENTATIVE AND ATTACHED TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1846379 FIXATIVE, FORMALIN FORMALDEHYDE (FORMALIN, FORMOL) IGG E K INDUSTRIES, INC. 24499-100X60ML 2127911

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown