BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERACOOL COLD THERAPY

    MDR report key: 1155461 · Received September 8, 2008

    Report

    Report Number
    3026585-2008-00003
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    March 21, 2007
    Report Date
    September 8, 2008
    Manufacturer
    OSSUR AMERICAS
    Product Code
    ILO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT SUFFERED FROSTBITE INJURIES WHILE USING THE THERACOOL COLD THERAPY PRODUCT THAT WAS PRESCRIBED BY THE TREATING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERACOOL COLD THERAPY ILO OSSUR AMERICAS CTSHS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention