BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE (PEN NEEDLE DISPOSABLE)

    MDR report key: 9853397 · Received March 18, 2020

    Report

    Report Number
    MW5093844
    Event Type
    Injury
    Date Received
    March 18, 2020
    Date of Event
    December 9, 2019
    Report Date
    December 9, 2019
    Manufacturer
    UNKNOWN
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTS SEVERAL INCIDENCE OF HIS INSULIN PEN NEEDLES BENDING WHILE INJECTING INSULIN. NO HARM TO THE PATIENT WAS REPORTED. THE PATIENT WAS EDUCATED ON PROPER TECHNIQUE OVER THE PHONE. THIS EVENT HAS BEEN REPORTED BY OTHER PATIENT'S USING THIS PARTICULAR BRAND OF NEEDLE. DROPLET PEN NEEDLE 8MM NDC 08489-8309-10. SYMPTOMS: 1. BENDING INSULIN NEEDLE SUSPECT DRUG # 1 DOSING# USE ONE NEEDLE FOR INJECTION 5 TIMES DAILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311657 NEEDLE (PEN NEEDLE DISPOSABLE) NEEDLE, HYPODERMIC, SINGLE LUMEN FMI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other