BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 20989310 · Received December 20, 2024

    Report

    Report Number
    3005798905-2024-03234
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    December 19, 2024
    Report Date
    December 20, 2024
    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

    CAUSE OF COMPLAINT TRACED TO UNINTENDED USER OF DEVICE.

    Description of Event or Problem · 0

    THE OFFICE MANAGER FOR AN AESTHETICS OFFICE REPORTED THAT ITEM 831365 LOTS 66782 EXPIRATION 02/24/2029, 66785 EXPIRATION 02/27/2027 AND 65236C EXPIRATION 11/27/2028 ARE LEAKING PRODUCT (BOTOX) OUT OF SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2154544 EASYTOUCH INSULIN SYRINGE FMF

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown