BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKFINE 31G X 3/16" PEN NEEDLE (5MM)

    MDR report key: 23907445 · Received December 29, 2025

    Report

    Report Number
    MW5181301
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Date of Event
    December 19, 2025
    Report Date
    December 19, 2025
    Manufacturer
    STAT MEDICAL DEVICES, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT'S DAUGHTER (B)(6) REPORTED THE PEN NEEDLES SENT WITH THE TYMLOS MEDICATION DO NOT LOOK LIKE THE OLD ONES, THE NEEDLES SEEM MORE BLUNT AND PUSHED INTO THEMSELVES. TYMLOS HAS EXTRA DOSES SO PHARMACIST SUGGESTED INJECTING A PIECE OF FRUIT TO SEE IF THE PEN NEEDLES MALFUNCTIONED IN ANY WAY, IF SO OR IF SHE FEELS UNCOMFORTABLE, SHE CAN GO TO LOCAL PHARMACY AND LOOK FOR PEN NEEDLES. SOMEONE FROM THE PHARMACY WILL REACH OUT TO SET UP A RESEND OF THE NEEDLES TO THE PATIENT. NO ADDITIONAL INFORMATION AVAILABLE. DIAGNOSIS FOR USE: M81.0 OSTEOPOROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2462264 CLICKFINE 31G X 3/16" PEN NEEDLE (5MM) NEEDLE, HYPODERMIC, SINGLE LUMEN FMI STAT MEDICAL DEVICES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female