BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD INST ICE PK L

    MDR report key: 5993022 · Received October 3, 2016

    Report

    Report Number
    3011270181-2016-00014
    Event Type
    Injury
    Date Received
    October 3, 2016
    Date of Event
    May 30, 2016
    Report Date
    November 21, 2016
    Manufacturer
    HALYARD HEALTH
    Product Code
    IMD
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL COMPLAINT PRODUCT IS ANTICIPATED BUT NOT YET RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT NUMBER BM5171XXX IS IN-PROGRESS. UPON COMPLETION OF THE INVESTIGATION; A FOLLOW-UP REPORT WILL BE FILED. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    THE RETURNED SAMPLE WAS VISUALLY INSPECTED. NO DAMAGE OR DEFECTS WERE SERVED. THE COLD PACK WAS PLACED ON AN ABSORBENT BLOTTER. NO LEAKAGE WAS SEEN. THE COLD PACK WAS PALPATED BY HAND, APPLYING PRESSURIZATION. NO LEAKAGE WAS SEEN WHEN PRESSURIZED FROM THE FRONT OR FROM THE BACK. THE ROOT CAUSE IS UNKNOWN AS NO ROOT CAUSE WAS IDENTIFIED. THE SAMPLE WAS DETERMINED TO BE APPROPRIATELY MANUFACTURED; COMPLAINT DESCRIPTION INDICATES THE PRODUCT WAS APPROPRIATELY USED. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THEY RECEIVED A 3RD DEGREE BURN AFTER USING AN INSTANT ICE PACK. THE PATIENT EXPLAINED THAT THE INSTANT COLD PACK WAS SQUEEZED TO ACTIVATE AS PER THE INSTRUCTIONS, AND PLACED ON THE HIP. THE PATIENT STATED THE INSTANT COLD PACK WAS IN USE FOR ONLY THREE MINUTES BEFORE FEELING DISCOMFORT. THE PATIENT NOTICED BLISTERS WHEN THE ICE PACK WAS REMOVED. THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS GIVEN NEOSPORIN OINTMENT AND NO FURTHER TREATMENT WAS PROVIDED. THE PATIENT ALLEGES THERE WILL BE PERMANENT SCARRING. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645756 STANDARD INST ICE PK L PATIENT CARE COLD THERAPY PRODUCTS IMD HALYARD HEALTH 59688 BM5171XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other