BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOT PAK MED 6 X 6.5

    MDR report key: 1273465 · Received December 22, 2008

    Report

    Report Number
    1423507-2008-00104
    Event Type
    Injury
    Date Received
    December 22, 2008
    Date of Event
    November 22, 2008
    Report Date
    December 22, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE INVOLVED IN THE INCIDENT WAS RECEIVED FOR EVALUATION AND THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE FOR THE REPORTED ISSUE WAS A MACHINE FAILURE AND THE DEFECTIVE PRODUCT SHOULD HAVE BEEN FOUND DURING THE PACKAGING PROCESS IN ORDER TO PREVENT THIS TYPE OF REPORT. THE MANUFACTURING FACILITIES QUALITY SYSTEMS MANDATE SUITABLE IN-PROCESS CONTROLS TO MEASURE SEAL INTEGRITY OF REPRESENTATIVE SAMPLES. SAMPLES ARE TESTED AT PREDETERMINED LOCATIONS TO BEST GAUGE SEAL INTEGRITY. ALL LOTS RELEASED BY THE QUALITY UNIT MEET PREDETERMINED RELEASE CRITERIA. THE DHR FOR LOT V8N083 WAS INVESTIGATED. NO ISSUES WERE DOCUMENTED DURING MANUFACTURE.

    Description of Event or Problem · 1

    EXPLODE. TWO HOT PACKS EXPLODED IN RADIOLOGY WHILE THEY WERE ACTIVATED. IT DID GET INTO THE CUSTOMER'S RIGHT EYE, NOSE AND MOUTH. NOT THE EARS. HER CHEST, ARMS AND FACE WERE COVERED WITH THE CHEMICAL. SHE SUSTAINED A CHEMICAL BURN OF THE RIGHT CONJUNCTIVA; CORNEAL ABRASION. SHE WENT TO THE E.R. INSTEAD OF CORPORATE HEALTH AS THIS HAPPENED ON A SATURDAY AND CORPORATE HEALTH WAS NOT OPEN. THE E.R. DID AN EYE EXAM AND A ONE HOUR EYE IRRIGATION. SHE WAS THEN SENT HOME WITH POLYTRIM DROPS TO THE EYE. SHE HAD TO FOLLOWUP WITH OPHTHALMOLOGY AT NMH IN 2008. SHE HAS NOTED SOME SLIGHT DISCOMFORT TO THAT EYE AT TIMES. SHE WILL BE SEEING HER OPHTHALMOLOGIST FOR A ROUTINE EXAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOT PAK MED 6 X 6.5 HOT PAK IMD CARDINAL HEALTH 11450-040 V8N083

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention