BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARCARE 300

    MDR report key: 519209 · Received March 18, 2004

    Report

    Report Number
    519209
    Event Type
    Malfunction
    Date Received
    March 18, 2004
    Date of Event
    February 25, 2004
    Report Date
    March 16, 2004
    Manufacturer
    BREG INC
    Product Code
    ILO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD SURGERY AND POLARCARE. PAD WAS PLACED ON KNEE OUTSIDE DRESSING PT DISCHARGED TO HOME. WHEN RETURNED TO DR FOR FOLLOW UP POST OP CARE AND DRESSING REMOVED WAS NOTED TO HAVE FROST BITE UNDER TUBING FROM PAD TO CONNECTION TO KOOLER. DR. REPORTED INCIDENT TO O.R. MANAGER AND GAVE KOOLER TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARCARE 300 KOOLING PAD & KOOLER ILO BREG INC 300 *

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other