BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE

    MDR report key: 16459336 · Received March 1, 2023

    Report

    Report Number
    16459336
    Event Type
    Malfunction
    Date Received
    March 1, 2023
    Date of Event
    January 26, 2023
    Report Date
    February 7, 2023
    Manufacturer
    OWENS & MINOR DISTRIBUTION, INC.
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    INSTANT COLD PACK ACTIVATED FOR COLD THERAPY, UPON ACTIVATION COLD PACK STARTED LEAKING ON RN'S HANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844754 MEDICHOICE GENERAL SURGERY TRAY LRO OWENS & MINOR DISTRIBUTION, INC. CWP903 2210RA03A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown