BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTICMED

    MDR report key: 22886305 · Received August 25, 2025

    Report

    Report Number
    22886305
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    July 16, 2025
    Report Date
    August 18, 2025
    Manufacturer
    ATLANTIC TRADING LLC
    Product Code
    MPO
    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

    HEEL WARMERS DEFECTIVE, NOT ABLE TO ACTIVATE WARMING DISC. DID NOT REACH THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553068 ATLANTICMED INFANT HEEL WARMER (CHEMICAL HEAT PACK) MPO ATLANTIC TRADING LLC ATL-IFW-0305 C0012212-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown