BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLAR CARE CUBE

    MDR report key: 7024342 · Received November 13, 2017

    Report

    Report Number
    7024342
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 27, 2017
    Report Date
    November 7, 2017
    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

    PATIENT WAS DISCONNECTING THEIR COOLER PACK AT HOME POST-TOTAL KNEE ARTHROPLASTY AND NOTED THE ELECTRICAL (MALE) CONNECTOR BROKE OFF OF THE ELECTRICAL CORD INTO THE FEMALE RECEPTACLE OF THE COOLER ITSELF RENDERING IT ALL UNUSABLE. NO HARM TO PATIENT AND THEY BROUGHT THE COMPLETE COOLER BACK TO THE HOSPITAL FOR A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804945 POLAR CARE CUBE PACK, HOT OR COLD, WATER CIRCULATING ILO BREG, INC. 272206494

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR