BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOT PAK LG 6X9

    MDR report key: 3113678 · Received May 15, 2013

    Report

    Report Number
    1423537-2013-00021
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    March 12, 2013
    Report Date
    May 15, 2013
    Manufacturer
    CARDINAL HEALTH
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS INITIATED INTO THIS REPORT CITING THE PRODUCT WAS DIFFICULT TO ACTIVATE RESULTING IN AN INJURY TO A STAFF MEMBER. AT THE TIME OF THIS REPORT, THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. WITHOUT THE LOT NUMBER, WE ARE UNABLE TO REVIEW THE DEVICE HISTORY RECORDS TO DETERMINE IF ANY DEVIATIONS TOOK PLACE DURING THE MANUFACTURING PROCESS OF THIS DEVICE. IN ADDITION, WITHOUT THE ACTUAL SAMPLE WE ARE ALSO UNABLE TO CONFIRM THE REPORT AND ASSIGN A ROOT CAUSE FOR THE COMPLAINT. A REVIEW OF THIS PRODUCT CATALOG NUMBER IDENTIFIED NO TRENDS BEING DETECTED FOR THIS ISSUE. IF THE PRODUCT IS RETURNED IN THE FUTURE, A FOLLOW-UP REPORT WILL BE FILED AND AN INVESTIGATION WILL BE REOPENED TO EVALUATE THE RETURNED SAMPLE.

    Description of Event or Problem · 1

    CUSTOMER STATED THE HOT PACK WAS DIFFICULT TO ACTIVATE RESULTING IN STAFF INJURY. THE STAFF MEMBER WITH THE INJURY NO LONGER WORKS AT THAT SITE SO WE COULD NOT BE MORE SPECIFIC WITH THE DIAGNOSIS AND DESCRIPTION OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214744 HOT PAK LG 6X9 HOT IMD CARDINAL HEALTH 11443-012 NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other