BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN COLD PACK

    MDR report key: 681401 · Received March 2, 2006

    Report

    Report Number
    1423507-2006-00024
    Event Type
    Other
    Date Received
    March 2, 2006
    Date of Event
    January 27, 2006
    Report Date
    March 2, 2006
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KYR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER SAID HER SON WAS KICKED AT SCHOOL AND HE WENT TO THE NURSE'S OFFICE SAYING IT WAS HURTING. SHE SAID THE NURSE TOOK THE COLD PACK OUT OF TEH FREEZER, APPLIED IT TO THE INJURED AREA, AND TOLD HER SONE TO LEAVE IT ON ABOUT 20 MINUTES, THEN GO BACK TO CLASS. SHE SAID THAT EVENING THERE WAS A RED RECTANGULAR AREA ON THE LEG THAT WAS REALLY RED, AND TINY WATER BLISTERS WERE FORMING. SHE SAID BY LATE SATURDAY AFTERNOON IT WAS "OOZING" OUT OF THE BLISTERS, SO THEY TOOK HIM TO THE ER. AT ER THEY WERE TOLD IT WAS INFECTED AND THEY GAVE HER SON ANTIBIOTICS TO TAKE. SHE SAID IT IS LOOKING BETTER, BUT SHE THINKS IT IS GOING TO LEAVE A SCAR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other