BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADENCE SCIENCE

    MDR report key: 6393142 · Received March 9, 2017

    Report

    Report Number
    1213649-2017-00001
    Event Type
    Malfunction
    Date Received
    March 9, 2017
    Date of Event
    August 9, 2013
    Report Date
    March 9, 2017
    Manufacturer
    CADENCE SCIENCE, INC.
    Product Code
    FMF
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CADENCE SCIENCE INC. ACKNOWLEDGES THIS REPORT DOES NOT MEET THE 30 DAY REPORTING REQUIREMENTS. THIS WAS UNINTENTIONAL. THIS REPORT IS BEING FILED AFTER IT WAS IDENTIFIED AS NONCOMPLIANT DURING AN INTERNAL REVIEW OF OUR COMPLAINT FILES.

    Description of Event or Problem · 1

    PACKAGE WAS LABELED P/N 5338 (1 ML SYRINGE) BUT CONTAINED P/N 5339 (2 ML SYRINGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176114 CADENCE SCIENCE 1 ML GLASS SYRINGE FMF CADENCE SCIENCE, INC. 5338 W005823/1

    Patients

    Seq Age Sex Outcome Treatment
    1