BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 371940 · Received January 16, 2002

    Report

    Report Number
    MW1023835
    Event Type
    Malfunction
    Date Received
    January 16, 2002
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP
    Product Code
    FMJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SPINAL FLUID WAS ABLE TO LEAK FROM THE HUB AFTER IT WAS SCREWED ON TO THE MODULE. THIS OCCURRED ON MORE THAN ONE SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ADULT LUMBAR PUNCTURE TRAY FMJ ALLEGIANCE HEALTHCARE CORP 4301C H1H011

    Patients

    Seq Age Sex Outcome Treatment
    1 *