BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASY TOUCH PEN NEEDLES

    MDR report key: 9586188 · Received January 13, 2020

    Report

    Report Number
    MW5092207
    Event Type
    Injury
    Date Received
    January 13, 2020
    Date of Event
    December 19, 2019
    Report Date
    January 9, 2020
    Manufacturer
    MHC MEDICAL PRODUCTS LLC.
    Product Code
    FMI
    UDI-DI
    08496300501
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE PT CALLED TO REPORT THAT HIS PEN NEEDLES (30 G 5/16") MANUFACTURED BY MHC MEDICAL PRODUCTS, LLC ARE MALFUNCTIONING. PT UNABLE TO INJECT INSULIN WITH THESE NEEDLES AND IS HAVING TO CHANGE THE NEEDLES TO INJECT THE DOSE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47195 EASY TOUCH PEN NEEDLES NEEDLE, HYPODERMIC, SINGLE LUMEN FMI MHC MEDICAL PRODUCTS LLC. 830561 08496300501

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention