BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 11641976 · Received April 9, 2021

    Report

    Report Number
    3005798905-2021-02996
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 2, 2021
    Report Date
    April 5, 2021
    Manufacturer
    MHC MEDICAL PRODUCTS, LLC
    Product Code
    FMF
    PMA / PMN Number
    K102178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE RETURNED FOR PRODUCT TESTING. RETAINED LOT # 51123 LIQUID DRAW TESTING SHOWED NO ABNORMALITIES OR MALFUNTIONS.

    Description of Event or Problem · 0

    END-USER IS HAVING DIFFICULTY GETTING AIR BUBBLES OUT THEIR SYRINGE.

    Description of Event or Problem · 1

    END-USER IS HAVING DIFFICULTY GETTING AIR BUBBLES OUT THEIR SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539831 EASYTOUCH INSULIN SYRINGE FMF MHC MEDICAL PRODUCTS, LLC 51123

    Patients

    Seq Age Sex Outcome Treatment
    1