BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREG INC. POLARCARE 500

    MDR report key: 2048282 · Received April 5, 2011

    Report

    Report Number
    MW5020183
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 5, 2011
    Manufacturer
    BREG, INC.
    Product Code
    ILO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POLARCARE 500 - HOSE NOT FUNCTIONING. NOT COOLING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREG INC. POLARCARE 500 POLARCARE 500 ILO BREG, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA