BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACE INSTANT COLD COMPRESS

    MDR report key: 1082218 · Received July 25, 2008

    Report

    Report Number
    2243072-2008-00046
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 24, 2008
    Manufacturer
    BECTON DICKINSON
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RECEIVED TO DATE, IF PRODUCT IS RETURNED, ANALYSIS WILL BE CONDUCTED. UNABLE TO RUN COMPLAINT HISTORY CHECK OR DEVICE HISTORY REVIEW AS LOT NUMBER IS UNK. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.

    Description of Event or Problem · 1

    CONSUMER REPORTED AFTER ACTIVATING INSTANT COLD COMPRESS AND BECAME COLD, SHE APPLIED IT ON HER BACK BELOW THE SHOULDER FOR ABOUT (20) MINUTES. IN ABOUT ONE (1) HOUR CONSUMER NOTICED THAT SHE HAS DEVELOPED A BLISTER THE SIZE OF THE COMPRESS. MEDICAL ATTENTION WAS SOUGHT AND SHE WAS TOLD THAT SHE HAD A BURN. CONSUMER WAS ADVISED TO APPLY NEOSPORIN AND VITAMIN E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACE INSTANT COLD COMPRESS INSTANT COLD COMPRESS IMD BECTON DICKINSON NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention