BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER HEALTHCARE FORMULIN 1:10

    MDR report key: 19423605 · Received May 30, 2024

    Report

    Report Number
    19423605
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    April 17, 2024
    Report Date
    May 22, 2024
    Manufacturer
    REMEL, INC.
    Product Code
    IFP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    STAFF MEMBER NOTICED THAT A BRAND NEW FORMALIN BOX WAS WET/SOAKED IN THE FORMALIN/SPECIMEN FILLING AREA BEHIND THE CONTROL DESK. THERE WAS NOT A SPILL, BUT THE BOX WAS WET AND HAD OBVIOUSLY BEEN SEEPING INTO THE CARDBOARD SURROUNDING THE PLASTIC CONTAINER INSIDE. BOX SAFELY REMOVED FROM SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150529 FISHER HEALTHCARE FORMULIN 1:10 FORMALIN, NEUTRAL BUFFERED IFP REMEL, INC. 23-245685

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown