BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 12816807 · Received November 15, 2021

    Report

    Report Number
    3005798905-2021-03022
    Event Type
    Malfunction
    Date Received
    November 15, 2021
    Date of Event
    September 23, 2021
    Report Date
    November 15, 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 TESTING. INITIAL TREND ANALYSIS FOR LOT 53101A WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 53101A. PRODUCTION RECORDS INVESTIGATED FOR LOT 53101A, THE TESTING SHOWED NO INDICATION OF ABNORMALITIES OR MALFUNCTION AT TIME OF PRODUCTION.

    Description of Event or Problem · 0

    USER REPORTS THAT HE BELIEVES THE SYRINGES HE PURCHASED DIRECTLY FROM TWO OF OUR DISTRIBUTORS ARE COUNTERFEIT. HE REPORTS THAT ITEM 828155 LOT 53101A IS COUNTERFEIT WHEN COMPARED TO ANOTHER EASYTOUCH SYRINGE, 829155. USER REPORTS THAT ITEM 828155 IS DULL, CANNULA IS NOT COATED IN SILICON, THE BARREL LACKS SUCTION AND THE MARKING ON THE OUTSIDE OF THE BARREL FADE QUICKLY OR ARE ALREADY FADED UPON OPENING THE POLY BAG. USER ALSO REPORTS RECEIVING ABSESSES FROM THE SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1708721 EASYTOUCH SYRINGES FMF MHC MEDICAL PRODUCTS, LLC 53101A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown