BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STATLAB SPECIMEN TRANSPORT CONTAINER

    MDR report key: 18392471 · Received December 22, 2023

    Report

    Report Number
    MW5149505
    Event Type
    Injury
    Date Received
    December 22, 2023
    Date of Event
    August 1, 2023
    Report Date
    December 20, 2023
    Manufacturer
    STATLAB MEDICAL PRODUCTS/SLMP LLC (STATLAB MEDICAL PRODUCTS)
    Product Code
    IFP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SEVERAL INSTANCES OF THE FLUID INSIDE THE CUP LEAKING OUT AFTER CLOSING. THE CUP LID "CLICKS" WHEN CLOSING TO INDICATE IT HAS SEALED. DISCOVERED MULTIPLE CUPS NOT CLICKING WHEN CLOSING. NOT ALL THE CUPS THAT DID NOT "CLICK" WHEN CLOSED LEAKED, BUT ALL THE CUPS THAT LEAKED DID NOT "CLICK". REFERENCE REPORT: MW5149506.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2292785 STATLAB SPECIMEN TRANSPORT CONTAINER FORMALIN, NEUTRAL BUFFERED IFP STATLAB MEDICAL PRODUCTS/SLMP LLC (STATLAB MEDICAL PRODUCTS) CH60NBFBJC

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Prefer Not To Disclose Required Intervention