BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT LUMBAR PUNCTURE TRAY 20X3 1/2

    MDR report key: 354745 · Received October 4, 2001

    Report

    Report Number
    1423507-2001-00236
    Event Type
    Malfunction
    Date Received
    October 4, 2001
    Date of Event
    September 5, 2001
    Report Date
    October 4, 2001
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Product Code
    IQE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DR STATES THAT CIRCUMSTANCES OF MANOMETER IS NOT RIGHT WHICH IS CAUSING A NON MEASUREMENT OF PRESSURE AND CAUSED LEAKAGE OF FLUID WHICH CAUSED PT TO EXPERIENCE POST HEADACHE SYMPTOMS CAUSING PT STAY TO EXCEED APPROXIMATELY 3HRS THEN GOING TO ER. SPOKE WITH RN WHO CONFIRMED ABOVE STATEMENT. SHE WAS NOT SURE WHAT TYPE OF ADDITIONAL MEDICATION OR INTERVENTION, OTHER THAN OBSERVATION, WAS REQUIRED AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44775 ADULT LUMBAR PUNCTURE TRAY 20X3 1/2 PROCEDURE TRAY IQE ALLEGIANCE HEALTHCARE CORP. 4301C L1J007

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other