BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOTEK

    MDR report key: 2112877 · Received May 27, 2011

    Report

    Report Number
    MW5020788
    Event Type
    Injury
    Date Received
    May 27, 2011
    Date of Event
    February 3, 2009
    Report Date
    May 27, 2011
    Product Code
    ILO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ARTHROSCOPIC KNEE SURGERY PT WAS INSTRUCTED TO USE COLD THERAPY MACHINE, IDENTIFIED AS A NANOTHERM THERAPY DEVICE, MANUFACTURED BY THERMOTEK AND DISTRIBUTED BY TEAM MAKENA. AFTER ABOUT 10 DAYS OF PHYSICIAN MONITORED USE, PT DEVELOPED 4TH DEGREE FROSTBITE OVER THE KNEE CAP. NANOTHERM USED FROM (B)(4) 2009. DIAGNOSIS OR REASON FOR USE: SWELLING REDUCTION AND ANALGESIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOTEK NANOTHERM ILO

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R