BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTANT COLD PACK

    MDR report key: 336894 · Received June 13, 2001

    Report

    Report Number
    1423507-2001-00169
    Event Type
    Injury
    Date Received
    June 13, 2001
    Report Date
    June 13, 2001
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP
    Product Code
    IMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EMPLOYEE SUSTAINED INJURY, USED ICE PACK & TOOK ICE PACK HOME. THE EMPLOYEE THEN REFROZE AND APPLIED TO RIGHT CALF AFTER SUSTAINING ANOTHER INJURY. THE PACK FELL DOWN TO ANKLE AREA AND THE EMPLOYEE SUSTAINED 3" X 4" MAROON DISCOLORATION TO SKIN. THE EMPLOYER RECOMMENDED THE EMPLOYEE SEEK MEDICAL ATTENTION REGARDING MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27114 INSTANT COLD PACK COLD PACK IMF ALLEGIANCE HEALTHCARE CORP 10104 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other