BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 16825075 · Received April 27, 2023

    Report

    Report Number
    3005798905-2023-03113
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Date of Event
    April 20, 2023
    Report Date
    April 27, 2023
    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

    INITIAL TREND ANALYSIS FOR LOT 59731B WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 59731B. CAUSE OF COMPLAINT WAS TRACED TO UNINTENDED USE OF DEVICE.

    Description of Event or Problem · 0

    A REPRESENTATIVE FROM A MEDICAL SPA REPORTS THAT THE INSULIN SYRINGES ITEM NUMBER 831565 LOT 59731B ARE DULL AND BENDING WHEN PUNCTURING THE RUBBER GASKET ON THE BOTOX VIALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614147 EASYTOUCH INSULIN SYRINGE FMF MHC MEDICAL PRODUCTS, LLC 59731B

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown