BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 11734266 · Received April 27, 2021

    Report

    Report Number
    3005798905-2021-03002
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    April 12, 2021
    Report Date
    April 26, 2021
    Manufacturer
    MHC MEDICAL PRODUCTS, LLC
    Product Code
    FMI
    PMA / PMN Number
    K112789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DURING INITIAL TREND ANALYSIS FOR LOT NUMBER 52093, NO OTHER COMPLAINTS WERE LOCATED. FURTHER INVESTIGATION WILL BE CONDUCTED FOR ROOT CAUSE OF COMPLAINT.

    Description of Event or Problem · 1

    END USER WAS PERFORMING AN INSULIN INJECTION AND THE SYRINGE "DEPLUGGED" DURING USE. NO MEDICAL INTERVENTION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630003 EASYTOUCH PEN NEEDLE FMI MHC MEDICAL PRODUCTS, LLC 52093

    Patients

    Seq Age Sex Outcome Treatment
    1