BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE

    MDR report key: 24931789 · Received April 20, 2026

    Report

    Report Number
    MW5187017
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Report Date
    April 15, 2026
    Manufacturer
    EMBECTA MEDICAL II LLC
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    TYMLOS AND PEN NEEDLE INDICATION: AGE-RELATED OSTEOPOROSIS WITHOUT CURRENT PATHOLOGICAL FRACTURE. PATIENT REPORTED HEART RATE HAS GONE UP, SINCE LAST FILL. PATIENT STATED THEY NOTIFIED MD. MD ADVISED PATIENT THAT IT MAY BE A PROBLEM WITH THYROID. PATIENT ALSO REPORTED ONE PEN NEEDLE BROKE BEFORE USING IT. UNKNOWN IF PATIENT MISSED DOSE. UNKNOWN IF PRODUCT IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239261 PEN NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL II LLC 320882

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female TYMLOS