BEUDAMED
    FDA Adverse Event Other Summary report: N

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    MDR report key: 1504505 · Received October 9, 2009

    Report

    Report Number
    9615387-2009-00037
    Event Type
    Other
    Date Received
    October 9, 2009
    Report Date
    October 9, 2009
    Manufacturer
    PYNG MEDICAL CORP.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT DOES NOT HAVE A 510 (K) NUMBER. (B) (4). AN ANALOGOUS PRODUCT SOLD IN THE US HAS 510 (K) NUMBER K080865. THE DEVICE WAS NOT BEING USED ON A PATIENT UNDER EMERGENCY CONDITIONS. IT WAS BEING USED ON A VOLUNTEER. IT WAS REPORTED TO PYNG MEDICAL CORP. THAT USER ERROR LIKELY CAUSED THIS INCIDENT.

    Description of Event or Problem · 1

    REMOVAL DIFFICULTY. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST1 INTRAOSSEOUS INFUSION SYSTEM FMI PYNG MEDICAL CORP. 01-0017-001RTR NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other