BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVONGO LANCET

    MDR report key: 14270721 · Received May 3, 2022

    Report

    Report Number
    3011196194-2022-00003
    Event Type
    Injury
    Date Received
    May 3, 2022
    Date of Event
    March 4, 2022
    Report Date
    March 25, 2022
    Manufacturer
    LIVONGO HEALTH
    Product Code
    QRK
    PMA / PMN Number
    K133584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LANCET WAS REQUESTED FROM THE MEMBER, BUT THIS HAS NOT BEEN RETURNED. MINOR INJURY OF SWELLING, BLEEDING AND BRUISING WERE REPORTED BY MEMBER. THIS REPORT IS BEING FILED DUE TO POTENTIAL OF INFECTION.

    Description of Event or Problem · 0

    LANCET NEEDLE WAS DEFECTIVE, AND LONGER THAN NORMAL, CAUSING BRUISING AND BLEEDING TO THE MEMBER'S FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2185350 LIVONGO LANCET LANCET QRK LIVONGO HEALTH 202103231090

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Prefer Not To Disclose Other