BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEURO PACK "A", STRL(MSJSG)640

    MDR report key: 162296 · Received April 14, 1998

    Report

    Report Number
    1423507-1998-00114
    Event Type
    Other
    Date Received
    April 14, 1998
    Date of Event
    March 24, 1998
    Manufacturer
    ALLEGIANCE HEALTHCARE
    Product Code
    FRL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALLEGIANCE INVESTIGATION: DEVICE HISTORY RECORD REVIEW TO DETERMINE COMPONENT PART AND LOT NUMBER. NO ALTERATIONS DONE TO THIS COMPONENT, THEREFORE SUPPLIER ISSUE. SUPPLIER NOTIFIED. MEDICAL ACTION INDUSTRIES INC. INVESTIGATION CO IS CURRENTLY EVALUATING AN ALTERNATIVE FOAM WITH IMPROVED ADHESION.

    Description of Event or Problem · 1

    THE NURSE SUSTAINED A NEEDLE STICK WHEN THE FOAM STRIP DETACHED FROM THE NEEDLE COUNTER. AS PER HOSP POLICY, THE NURSE IS UNDERGOING BLOOD TESTING EVERY THREE MOS FOR EIGHTEEN MOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURO PACK "A", STRL(MSJSG)640 NEURO PACK "A" STRL(MSJSG)640 FRL ALLEGIANCE HEALTHCARE SNE54MSJSH 637981

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other