BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON

    MDR report key: 146993 · Received January 23, 1998

    Report

    Report Number
    MW4002112
    Event Type
    Malfunction
    Date Received
    January 23, 1998
    Report Date
    January 21, 1998
    Manufacturer
    PHARMACIA & UPJOHN CO.
    Product Code
    LZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    2 UNITS HAVE DEFECTIVE PLASTIC ROD. THE ROD IS MISSING THREADS THAT ARE NEEDED TO ASSEMBLE SYRINGE FOR USE. UNITS ARE AVAILABLE FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEALON SODIUM HYALURONATE 0.55ML LZP PHARMACIA & UPJOHN CO. NA YK56648

    Patients

    Seq Age Sex Outcome Treatment
    1 NA