BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORMALIN

    MDR report key: 14083799 · Received April 12, 2022

    Report

    Report Number
    14083799
    Event Type
    Malfunction
    Date Received
    April 12, 2022
    Date of Event
    March 15, 2022
    Report Date
    March 31, 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

    20 ML STATLAB FORMALIN CONTAINER LID CRACKED. CONTAINER DELIVERED FROM WESTERLY UROLOGY TO WESTERLY HOSPITAL HISTOLOGY DEPARTMENT. SPECIMEN PRESENT IN CONTAINER AND TEST ABLE TO BE RUN ON SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190311 FORMALIN FORMALIN, NEUTRAL BUFFERED IFP SLMP LLC (STATLAB MEDICAL PRODUCTS)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown