BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASY TOUCH LANCING DEVICE

    MDR report key: 3111900 · Received May 14, 2013

    Report

    Report Number
    2954323-2013-00270
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Product Code
    FMK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE: THE LANCING DEVICE IS NOT LABELED FOR SINGLE USE, HOWEVER, THE LANCETS ARE LABELED FOR SINGLE USE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. NOTE: THE MANUFACTURE DATE OF THE LANCING DEVICE IS UNKNOWN. THIS IS A FINAL REPORT. IT WAS REPORTED THAT THE LANCING DEVICE WILL NOT BE RETURNED; HENCE NO PRODUCT INVESTIGATION WILL BE UNDERTAKEN.

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL (PHARMACIST) REPORTED THAT THEY "HAD BEEN INFORMED THAT AN (ADC) METER HAD BEEN FOUND IN A HOTEL AND (A) STAFF MEMBER ACCIDENTALLY PRICKED THEIR FINGER" WITH ADC LANCING DEVICE. IT WAS FURTHER REPORTED THAT THE HOTEL STAFF MEMBER HAD THEIR BLOOD TAKEN AT A LOCAL HEALTH CARE FACILITY FOR UNSPECIFIED TESTS TO BE PERFORMED. NO OTHER INFORMATION WAS PROVIDED BY THE CALLER. 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
    213468 EASY TOUCH LANCING DEVICE LANCING DEVICE FMK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention