BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN COLD PACK

    MDR report key: 756492 · Received August 30, 2006

    Report

    Report Number
    1423507-2006-00100
    Event Type
    Other
    Date Received
    August 30, 2006
    Date of Event
    June 14, 2006
    Report Date
    August 30, 2006
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KYR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO SAMPLES WERE PROVIDED TO DATE, THE EXACT CAUSE OF THE DIFFICULTIES ENCOUNTERED CANNOT BE DETERMINED. IN ADDITION, NO LOT NUMBER WAS REPORTED, SO THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. UNDER ROUTING PRODUCTION, A SAMPLING OF THESE UNITS IS TESTED FOR POUCH INTEGRITY AND THE PRODUCTION RUN IS NOT RELEASED UNTIL ALL ASPECTS OF PRODUCT QUALITY MEET PRODUCT SPECIFICATIONS. ALTHOUGH GREAT EFFORT IS TAKEN IN ENSURING THAT ALL FUNCTION AS DESIGNED, AT TIMES, ONE MAY FAIL TO MEET PERFORMANCE EXPECTATIONS FOR A CERTAIN REASON. IN THOSE INSTANCES, IT IS VITAL TO THE INVESTIGATION THAT THE PRODUCT SAMPLE BE AVAILABLE FOR EXAMINATION AND TESTING IN ORDER TO DETERMINE THE ROOT CAUSE. UNFORTUNATELY, IN THIS SITUATION THAT IS NOT THE CASE. WE WILL CONTINUE TO MONITOR FOR OTHER SIMILAR COMPLAINTS AND UTILIZE THE INFORMATION AS PART OF CONTINUOUS IMPROVEMENT.

    Description of Event or Problem · 1

    SHE SAID, SHE HAD RECEIVED THE GEL PACK FROM SOMEONE ELSE. SHE SAID, THE PACK WAS FROZEN, AND SHE PLACED IT IN A TOWEL AND THEN PLACED IT ON HER BACK AND LAY DOWN. SHE SAID, THAT IS WAS ON HER BACK FOR LESS THAN 10 MINUTES AND SHE NOTICED IT WAS REALLY COLD, SO SHE TOOK IT OFF HER BACK. THAT IS WHEN SHE SAID THAT SHE NOTICED A BURN ON HER BACK. SHE WENT TO THE DOCTOR, AND SAID THAT BY THIS TIME, THERE WAS BLISTER FORMING AND THE BURNED AREA WAS 5 1/2"X6: IN DIAMETER.

    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