BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE NAVIGATOR

    MDR report key: 3173807 · Received June 17, 2013

    Report

    Report Number
    2954323-2013-00341
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 22, 2013
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PARTICIPANT IN CLINICAL TRIAL EXPERIENCED MODERATE ERYTHEMA, MILD BLEEDING, PAIN AND ITCHING AT THE SITE OF SENSOR INSERTION ON THEIR ARM. IT WAS FURTHER REPORTED THAT THIS STUDY PARTICIPANT WAS SEEN BY A DOCTOR AND WAS PRESCRIBED FUCIBET CREAM (A COMBINATION OF AN ANTIBIOTIC AND A CORTICOSTEROID) AND SYMPTOMS RESOLVED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273435 FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM MDS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention