BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM

    MDR report key: 15272757 · Received August 23, 2022

    Report

    Report Number
    3016525500-2022-00013
    Event Type
    Injury
    Date Received
    August 23, 2022
    Date of Event
    July 25, 2022
    Report Date
    September 12, 2023
    Manufacturer
    BIGFOOT BIOMEDICAL, INC
    Product Code
    QLG
    UDI-DI
    00850003506395
    PMA / PMN Number
    K202145N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364767 BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM DIABETES MANAGEMENT SYSTEM QLG BIGFOOT BIOMEDICAL, INC FG-300205 13516 00850003506395

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Hospitalization