BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE

    MDR report key: 7780272 · Received August 10, 2018

    Report

    Report Number
    MW5079086
    Event Type
    Injury
    Date Received
    August 10, 2018
    Date of Event
    May 30, 2018
    Report Date
    July 31, 2018
    Manufacturer
    HTL - STREFA INC.
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PER PHARMACIST'S NARRATIVE, VETERAN REPORTING PAIN, AND INCOMPLETE ABSORPTION OF INSULIN DOSES AS INSULIN LEAKS FROM INJECTION SITE. REQUESTING 8MM PEN NEEDLES. CONFIRMED CORRECT INJECTION TECHNIQUE. VETERAN USES 4 NEEDLES DAILY: NOVOLOG PEN X TIDAC, TRESIBA PEN X QHS. USED PEN NEEDLE AS DIRECTED FOR INSULIN INJECTION; 1 UNITS - PRN - SQ, (B)(6) 2018 THROUGH (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615406 NEEDLE NEEDLE FMI HTL - STREFA INC.
    615410 NEEDLE NEEDLE FMI HTL - STREFA INC. Y56A5 8489831510
    615411 NEEDLE NEEDLE FMI HTL - STREFA INC.
    615412 NEEDLE NEEDLE FMI HTL - STREFA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other