BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 62936 · Received January 15, 1997

    Report

    Report Number
    9681834-1996-00064
    Event Type
    Injury
    Date Received
    January 15, 1997
    Date of Event
    November 8, 1996
    Product Code
    FJI
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    A RETENTION SAMPLE FROM THE SAME LOT NUMBER AS THE INVOLVED DEVICE WAS EVALUATED BY THE MANUFACTURING FACILITY USING PRIMARY BIO-SAFETY TESTS. THESE TESTS INCLUDED LAL, RABBIT PYROGEN, HEMOLYSIS, INTRACUTANEOUS TOXICITY, AND ACUTE TOXICITY. ALL RESULTS MET STANDARD SPECIFICATION, INDICATING PROPER BIO-SAFETY. 2243621-1996-352.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * FJI NA 8896D23

    Patients

    Seq Age Sex Outcome Treatment
    1
    2