BEUDAMED
    FDA Adverse Event Other Summary report: N

    REUS COLD PK MED 6X8.75

    MDR report key: 708437 · Received May 4, 2006

    Report

    Report Number
    1423507-2006-00056
    Event Type
    Other
    Date Received
    May 4, 2006
    Date of Event
    March 27, 2006
    Report Date
    May 4, 2006
    Manufacturer
    CARDINAL HEALTH
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT SHE RECEIVED A 2ND DEGREE BURN ON HER LOWERE LEG FOLLOWING THE USE OF THE JACK FROST REUSEABLE COLD PACK. IT WAS SHE 2ND USE OF THE PACK. SHE APPLIED IT DIRECTLY TO HER SKIN FOR 30 MINUTES AS DIRECTED ON THE PACK, SHE SAID. SHE SOUGHT MEICAL ATTENTION AND RECEIVED A TETANUS SHOT AND ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REUS COLD PK MED 6X8.75 COLD PACK IMD CARDINAL HEALTH 20104 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other