BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1972090 · Received January 27, 2011

    Report

    Report Number
    2954323-2011-01226
    Event Type
    Injury
    Date Received
    January 27, 2011
    Date of Event
    December 29, 2010
    Report Date
    January 27, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCTS HAVE BEEN REQUESTED BACK FOR INVESTIGATION AND A SUPPLEMENTAL REPORT WILL BE SENT ONCE NEW INFORMATION IS OBTAINED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED EXPERIENCING AN INJURY WITH AN ADC PRODUCT APPROXIMATELY FIVE MONTHS AGO. THEY SPECIFICALLY REPORTED THAT TEST STRIP FRAGMENTS WERE IN THE ADC TEST STRIP CONTAINER AND BLEW INTO HIS LEFT EYE WHEN HE SET THE CONTAINER NEAR A FAN. HE REPORTED EXPERIENCING SYMPTOMS OF "REDNESS, FLASHING SPOTS AND IRRITATION" AND HAD THE FRAGMENTS REMOVED AT A HEALTH CARE FACILITY. HE WAS TREATED WITH UNKNOWN MEDICATION AND THE CUSTOMER'S EYE REPORTEDLY "RETURNED TO NORMAL". NO SPECIFIC TREATMENT OR DIAGNOSIS WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other