BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH LANCING DEVICE

    MDR report key: 2893684 · Received January 2, 2013

    Report

    Report Number
    2954323-2013-00003
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    January 25, 2010
    Report Date
    December 10, 2012
    Product Code
    FMK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS SECTION SHOULD HAVE THE TYPE OF LANCING DEVICE-FREESTYLE FLASH LANCING DEVICE. THIS SECTION HAS BEEN UPDATED TO REFLECT THE CORRECT INFORMATION.

    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. NOTE: THE LANCING DEVICE'S MANUFACTURE DATE IS UNKNOWN, THE DATE ENTERED IS THE DATE WHEN ABBOTT DIABETES CARE BECAME AWARE OF THIS MEDICAL EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE BELIEVES THAT WHILE USING AN ADC LANCING DEVICE PART OF THE "LANCET BROKE OFF (IN) PIECES INTO HER FINGER". CUSTOMER FURTHER REPORTED EXPERIENCING SYMPTOMS THAT WERE DESCRIBED AS "SWELLING AND NUMBNESS ON HER FINGER". CUSTOMER REPORTED SELF-PRESENTING TO A LOCAL HEALTH CARE FACILITY WHERE SHE WAS GIVEN "A TECHNIQUE SHOT TO PREVENT ANY INFECTION", WHICH WAS NEW NOT PREVIOUSLY PRESCRIBED MEDICATION. CUSTOMER ALSO STATED THAT SHE TOOK IBUPROFEN PILL EVERY 4 TO 6 HOURS AND PLACED ICE ON HER FINGER. 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
    559 FREESTYLE FLASH LANCING DEVICE LANCING DEVICE FMK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention