BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK COLD PACK

    MDR report key: 588592 · Received April 7, 2005

    Report

    Report Number
    1423507-2005-00050
    Event Type
    Other
    Date Received
    April 7, 2005
    Date of Event
    March 8, 2005
    Report Date
    April 7, 2005
    Manufacturer
    CARDINAL HEALTH
    Product Code
    ILO
    Removal / Correction Number
    X
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ATTORNEY SPOKE TO A CARDINAL EMPLOYEE AT THE CARDINAL FACILITY ASKING FOR A COPY OF THE DIRECTIONS FOR USE FOR AN INSULATED 4 X 6 GEL PACK. PART NUMBER WAS NOT KNOWN. HE SAID HE WAS REPRESENTING A CHLROPRACTOR WHO HAD APPLIED THE GEL PACK DIRECTLY FROM THE FREEZER ONTO THE PT'S BARE BACK AND THE PT IS SUING THE CHLROPRACTOR BECAUSE THEY RECEIVED A BURN FROM THE GEL PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK COLD PACK COLD PACK ILO CARDINAL HEALTH UNKCOLDPK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other