BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORMALIN

    MDR report key: 14083549 · Received April 12, 2022

    Report

    Report Number
    14083549
    Event Type
    Malfunction
    Date Received
    April 12, 2022
    Date of Event
    February 14, 2022
    Report Date
    April 5, 2022
    Manufacturer
    SLMP LLC (STATLAB MEDICAL PRODUCTS)
    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

    STATLAB 20 ML FORMALIN CONTAINERS HAVE A CRACK IN THE LID FOR TWO SEPARATE PATIENTS. PATHOLOGY TESTS WERE ABLE TO BE PERFORMED AND NO HARM TO PATIENTS OCCURRED. I DO NOT KNOW IF IT WAS PRODUCT RELATED OR USER CLOSED THE LID TOO TIGHT. SPECIMEN PART A SMALL BOWEL BIOPSY SPECIMEN PART D GASTRIC POLYP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322680 FORMALIN FORMALIN, NEUTRAL BUFFERED IFP SLMP LLC (STATLAB MEDICAL PRODUCTS)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown