BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLAR CARE CUBE

    MDR report key: 9727684 · Received February 19, 2020

    Report

    Report Number
    2028253-2020-00001
    Event Type
    Injury
    Date Received
    February 19, 2020
    Report Date
    February 12, 2020
    Manufacturer
    BREG, INC
    Product Code
    ILO
    UDI-DI
    00672736017647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION, NOR LOT NUMBER PROVIDED. A REVIEW OF INTERNAL FILES FROM DATE OF INCIDENT TO DATE IDENTIFIED NO OTHER REPORTS OF THIS ALLEGED INCIDENT.

    Description of Event or Problem · 1

    THROUGH LEGAL NOTICE BREG, INC. RECEIVED A REPORT OF AN ALLEGED INCIDENT INVOLVING A POLAR CARE CUBE. THE COURT DOCUMENT ALLEGES THAT IN 2018, THE PLAINTIFF SUFFERED "FOCAL NECROSIS, MUSCLE WASTING, AND COMPLEX REGIONAL PAIN SYNDROME, WHICH IS A FORM OF HYPER-SENSITIVE NERVE DAMAGE THAT IS IRREVERSIBLE, DISABLING, AND EXTREMELY PAINFUL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190780 POLAR CARE CUBE POLAR CARE CUBE ILO BREG, INC 10701 00672736017647

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability