BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLEAGUE

    MDR report key: 2222886 · Received August 25, 2011

    Report

    Report Number
    6000001-2011-20634
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    February 5, 2006
    Report Date
    August 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4) - IT IS UNKNOWN IF THE DEVICE WAS AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION OR THE DEVICE BECOME AVAILABLE, OR AT THE CONCLUSION OF BAXTER'S INVESTIGATION, A FOLLOW UP WILL BE SUBMITTED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. THE SOFTWARE VERSION IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    BAXTER-(B)(4) RECEIVED REPORT THAT DURING HOSPITALIZATION FOR AN UNRELATED ILLNESS, THE PATIENT WAS ADMINISTERED AN INTRAVENOUS (IV) DRIP WHERE THE NEEDLE WAS INSERTED INTO THE FOOT. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2006. THE PATIENT'S MOTHER REPORTED THAT THE IV INSERTION SITE WAS NOT VISIBLE DUE TO THE FOOT BEING BANDAGED. THE IV DRIP DETACHED TWICE DURING THE MOTHER'S VISIT ON (B)(6) 2011; THE FOLLOWING DAY THE MOTHER WAS INFORMED THAT THE IV HAD APPARENTLY INFILTRATED THE PATIENT'S FOOT. AS A RESULT, THE PATIENT'S ENTIRE LEG WAS SWOLLEN AND THE FOOT WAS SERIOUSLY INFECTED. A PLASTIC SURGEON WAS CONSULTED WHO STATED THAT EVERYTHING WOULD HEAL IN TIME. ON (B)(6) 2006, AFTER HIS DISCHARGE HOME, A HOME CARE NURSE, WHO VISITED THOUGHT THE WOUNDS APPEARED VERY SERIOUS. THE PATIENT WAS TAKEN BACK TO THE PLASTIC SURGEON ON (B)(6) 2011 AND (B)(6) 2006 FOR FOLLOW UP. THE PLASTIC SURGEON BELIEVED THAT EVERYTHING WAS NORMAL AND THAT THE WOUND WAS HEALING WELL. THE PATIENT WAS INSTRUCTED TO RETURN FOR FOLLOW UP ON (B)(6) 2006. ON (B)(6) 2006, THE PARENTS TOOK THE PATIENT TO A DERMATOLOGIST AS THE WOUND WAS NOT HEALING. THE DERMATOLOGIST DETERMINED THAT THE WOUNDS WERE IN NEED OF EMERGENT CARE AND THE PATIENT WAS SENT TO A LOCAL BURN CENTER FOR CONSULTATION AND TREATMENT. SUBSEQUENTLY, TWO SKIN GRAFTING PROCEDURES WERE PERFORMED AT THE TIME OF THIS REPORT (DATES NOT REPORTED) WITH A THIRD PROCEDURE POSSIBLY NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R