BEUDAMED
    FDA Adverse Event Other Summary report: N

    FAST I

    MDR report key: 606372 · Received January 27, 2004

    Report

    Report Number
    9615387-2004-00012
    Event Type
    Other
    Date Received
    January 27, 2004
    Date of Event
    January 1, 2004
    Report Date
    January 27, 2004
    Manufacturer
    PYNG MEDICAL CORP.
    Product Code
    FMI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CAREGIVER ATTEMPTED INSERTION OF FAST, DEVICE. THE ATTEMPTS WAS UNSUCCESSFUL IN THAT HE COULD NOT RELEASE THE DEVICE ON PATIENT. SUBSEQUENTLY HE RELEASED THE DEVICE ON THE TRAINING SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST I STERNAL I.O. FMI PYNG MEDICAL CORP. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Other