BEUDAMED
    FDA Adverse Event Other Summary report: N

    F.A.S.T. 1

    MDR report key: 730849 · Received May 30, 2006

    Report

    Report Number
    9615387-2006-00006
    Event Type
    Other
    Date Received
    May 30, 2006
    Date of Event
    May 1, 2006
    Report Date
    May 30, 2006
    Manufacturer
    PYNG MEDICAL CORP.
    Product Code
    FMI
    PMA / PMN Number
    K970380
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    H6: STILL UNDER PMC EVALUATION 510(K) # IS K970380.

    Description of Event or Problem · 1

    REMOVAL DIFFICULTY PMC REF # CC-132

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM FMI PYNG MEDICAL CORP. F.A.S.T. 1 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other