BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONGS

    MDR report key: 328437 · Received April 19, 2001

    Report

    Report Number
    MW4002975
    Event Type
    Malfunction
    Date Received
    April 19, 2001
    Report Date
    March 7, 2001
    Manufacturer
    AUTOMATIC LIQUID PACKAGING, INC.
    Product Code
    LPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BLUE INK FLAKES OFF ON HANDS WHEN LABEL IS MOIST. DISTRIBUTOR NOTIFIED, AND ACKNOWLEGES PROBLEM, BUT THOUGHT IT HAD BEEN RESOLVED WITH LOTS MFG EARLIER THAN LOT INVOLVED IN THIS COMPLAINT. PLANS TO OUTSOURCE FUTURE MFG TO ALCON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17932 LONGS SALINE SOLUTION 15 FL OZ LPN AUTOMATIC LIQUID PACKAGING, INC. * 0N032

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO