BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE NAVIGATOR

    MDR report key: 2032869 · Received March 29, 2011

    Report

    Report Number
    2954323-2011-02696
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 29, 2011
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: THE DATE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    AN ADC CUSTOMER REPORTED HE EXPERIENCED BRUISING AND CYSTS OF THE SIZE OF A GRAPE OR A PEA AT THE SENSOR INSERTION SITE OF HIS FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM. THE CUSTOMER ALSO REPORTED HE WAS SEEN BY A DOCTOR AND RECEIVED ANTIBIOTICS TWICE WHICH HE KNEW THEY WERE "STRONG", BUT HE COULD NOT RECALL THE NAME OF THE MEDICATIONS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention