BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORMALIN

    MDR report key: 14205561 · Received April 26, 2022

    Report

    Report Number
    14205561
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Date of Event
    April 13, 2022
    Report Date
    April 18, 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 20ML FORMALIN CONTAINER LID CRACKED TISSUE PRESENT IN CONTAINER AND TEST WAS ABLE TO RUN. MANUFACTURER RESPONSE FOR FORMALIN CONTAINER, (BRAND NOT PROVIDED) (PER SITE REPORTER). WE HAVE FILED MULTIPLE COMPLAINTS TO MEDSUN AND TO THE MANUFACTURER. WE HAVE PROVIDED THEM A SAMPLE OF THE CRACKED LIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027169 FORMALIN FORMALIN, NEUTRAL BUFFERED IFP SLMP LLC (STATLAB MEDICAL PRODUCTS)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown