BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 11681883 · Received April 16, 2021

    Report

    Report Number
    3005798905-2021-02998
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 10, 2021
    Report Date
    April 9, 2021
    Manufacturer
    MHC MEDICAL PRODUCTS, LLC
    Product Code
    FMI
    PMA / PMN Number
    K112789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCTION RECORDS WERE ANALYZED FOR LOT 51439 FOR THE PENETRATION FORCE. THE TESTING SHOWED NO INDICATIOR OF ABNORMALITIES OR MALFUNCTIONS WERE FOUND AT TIME OF PRODUCTION.

    Description of Event or Problem · 0

    PHARMACY REPORTED A MALFUNCTION OF THE PEN NEEDLES FOR AN END USER IN WHICH THE END USER REPORTED THAT THE PEN NEEDLES CAUSED BLEEDING DUE TO THE DULLNESS OF THE NEEDLES WHILE USING.

    Additional Manufacturer Narrative · 1

    WHEN INITIAL TREND ANALYSIS FOR LOT NUMBER 51439 WAS CONDUCTED THIS WAS THE ONLY COMPLAINT FOR THE LOT NUMBER PROVIDED. FURTHER INVESTIGATION WILL BE CONDUCTED FOR ROOT CAUSE OF COMPLAINT.

    Description of Event or Problem · 1

    PHARMACY REPORTED A MALFUNCTION OF THE PEN NEEDLES FOR AN END USER IN WHICH THE END USER REPORTED THAT THE PEN NEEDLES CAUSED BLEEDING DUE TO THE DULLNESS OF THE NEEDLES WHILE USING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577696 EASYTOUCH PEN NEEDLE FMI MHC MEDICAL PRODUCTS, LLC 51439

    Patients

    Seq Age Sex Outcome Treatment
    1