BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLD PAK T-PAK 6X9

    MDR report key: 4871391 · Received June 26, 2015

    Report

    Report Number
    1423537-2015-00044
    Event Type
    Injury
    Date Received
    June 26, 2015
    Date of Event
    May 12, 2012
    Report Date
    June 26, 2015
    Manufacturer
    CARDINAL HEALTH
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS RECEIVED AND FORWARDED ON TO THE MANUFACTURING FACILITY FOR INVESTIGATION. THE ACTUAL PRODUCT OR SAMPLE OF THE PRODUCT WAS NOT PROVIDED OR ATTACHED TO THE COMPLAINT FOR INVESTIGATION. ALTHOUGH CATALOG NUMBER 11440-900 WAS PROVIDED, A LOT NUMBER COULD NOT BE OBTAINED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. WITHOUT INFORMATION AS TO THE LOT NUMBER OR A SAMPLE BEING PROVIDED, A MORE DETAILED INVESTIGATION CANNOT BE COMPLETED. IF THIS INFORMATION IS PROVIDED AT A LATER DATE, THE NECESSARY INVESTIGATION WILL BE COMPLETED AND A FOLLOW-UP REPORT FILED. IT SHOULD BE NOTED ON THE INSTRUCTIONS PRINTED ON THE T-PAK, THAT IT IS FOR "SINGLE USE ONLY". THE INSTRUCTIONS ALSO PROVIDE INSTRUCTION STATING "DO NOT FREEZE OR REFRIGERATE", "REFRIGERATION PRIOR TO APPLICATION, MAY RESULT IN FROSTBITE", AND ¿FREEZING OR REFRIGERATION PRIOR TO USE MAY CAUSE INJURY, INCLUDING FROST BITE.¿ BASED ON (B)(6) ASSERTIONS, AS STATED IN HER COMPLAINT, (B)(6) PLACED THE ICE PACK IN THE REFRIGERATOR AND RE-USED IT A DAY LATER.

    Description of Event or Problem · 1

    BASED ON PLAINTIFF (B)(6) ASSERTED CLAIMS, SHE SOUGHT AND RECEIVED MEDICAL TREATMENT FROM HEALTH CARE PROVIDERS AT THE (B)(6)., WHICH INCLUDED AN INJECTION OF HER RIGHT EPICONDYLE WITH A STEROID. FOLLOWING THIS PROCEDURE, (B)(6)WAS PROVIDED AN ICE PACK AND AS A RESULT (B)(6) ALLEGEDLY SUSTAINED SECOND DEGREE BURNS. (B)(6) ALLEGES HER INJURIES ARE A DIRECT RESULT FROM THE HEALTHCARE PROVIDERS¿ BREACHES IN NURSING/MEDICAL AND PRODUCT CARE IN ACCORDANCE WITH APPROPRIATE STANDARDS OF MEDICAL, NURSING AND PRODUCT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416127 COLD PAK T-PAK 6X9 COLD PACK IMD CARDINAL HEALTH 11440-900

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R