BEUDAMED
    FDA Adverse Event Other Summary report: N

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    MDR report key: 1461695 · Received June 10, 2009

    Report

    Report Number
    9615387-2009-00024
    Event Type
    Other
    Date Received
    June 10, 2009
    Date of Event
    February 1, 2009
    Report Date
    June 10, 2009
    Manufacturer
    PYNG MEDICAL CORP.
    Product Code
    FMI
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MODEL NUMBER IS UNK, THEREFORE, THE 510(K) NUMBER, IF APPLICABLE, IS UNCERTAIN. THIS PRODUCT HAS (B) (4) AND A (B) (4). ANALAGOUS PRODUCTS IN THE US HAVE 510(K) NUMBERS K970380, K072487 OR K080865. THE PHONE NUMBER PROVIDED BY THE CALLER AND LEFT ON THE VOICEMAIL WAS INCORRECT. NO FURTHER CONTACT OR FOLLOW-UP COULD BE PERFORMED. PYNG ATTEMPTED TO FOLLOW-UP 10 TIMES WITHOUT SUCCESS.

    Description of Event or Problem · 1

    REMOVAL DIFFICULTY. RECEIVED A VOICEMAIL MESSAGE FROM (B) (6). THE MESSAGE STATED THAT "THE FAST1 WAS BEING USED AS A TRAINING AID" AND WHEN "PULLING THE CATHETER OUT THE METAL TIP STAYED IN THE PERSON'S CHEST." (B) (4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other