BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 14251783 · Received April 29, 2022

    Report

    Report Number
    3005798905-2022-03055
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    April 13, 2022
    Report Date
    April 28, 2022
    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 · 0

    INITIAL TREND ANALYSIS FOR LOT 473712P WAS CONDUCTED, ANOTHER COMPLAINT WAS FOUND USING THE PEN NEEDLES. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.

    Description of Event or Problem · 0

    END USER REPORTS THAT PEN NEEDLES FROM LOT NUMBER 473712P EXPIRATION DATE 01/13/2023 ARE CLOGGING WHILE USING A LANTUS AND HUMALOG INSULIN PEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97768 EASYTOUCH PEN NEEDLE FMI MHC MEDICAL PRODUCTS, LLC 473712P

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown