BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLAR CARE GLACIER

    MDR report key: 8741820 · Received June 27, 2019

    Report

    Report Number
    2028253-2019-00002
    Event Type
    Injury
    Date Received
    June 27, 2019
    Report Date
    February 28, 2023
    Manufacturer
    BREG, INC.
    Product Code
    ILO
    UDI-DI
    00672736021699
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON FEBRUARY 2, 2023, THE DEVICE HISTORY RECORD FOR LOT NUMBER 262119126 WAS REVIEWED AFTER BREG WAS MADE AWARE OF THE LOT NUMBER ASSOCIATED WITH MDR: 2028253-2019-00002. POLAR GLACIER DEVICE FROM LOT NUMBER 262119126 WAS MANUFACTURED ON DECEMBER 21, 2016. A DEVICE HISTORY FOR THE LOT INVOLVED #262119126 WAS REVIEWED. THERE WERE NO NON-CONFORMANCES REPORTS OR DEVIATIONS ISSUED DURING THE MANUFACTURING OF THE PRODUCT. NO CHANGES ON MATERIALS OR MANUFACTURING PROCESSES WERE MADE. ALL IN PROCESS INSPECTIONS PASSED, NO ANOMALIES WERE IDENTIFIED DURING THE MANUFACTURING OF THE LOT. FINAL INSPECTION REQUIREMENTS WERE MET PRIOR TO RELEASE.

    Description of Event or Problem · 0

    ON FEBRUARY 2, 2023, THE DEVICE HISTORY RECORD FOR LOT NUMBER 262119126 WAS REVIEWED AFTER BREG WAS MADE AWARE OF THE LOT NUMBER ASSOCIATED WITH MDR: 2028253-2019-00002.

    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 FOR 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 GLACIER. THE COURT DOCUMENT ALLEGES THAT ON OR BEFORE (B)(6) 2017, A PLAINTIFF, "SUSTAINED A NON-FREEZING COLD INJURY RESULTING IN HER PERMANENT DISFIGUREMENT AND DISABILITY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535804 POLAR CARE GLACIER POLAR CARE GLACIER ILO BREG, INC. 10901 262119126 00672736021699

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention