BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON 0.85ML

    MDR report key: 130982 · Received October 27, 1997

    Report

    Report Number
    MW4002037
    Event Type
    Malfunction
    Date Received
    October 27, 1997
    Date of Event
    October 14, 1997
    Report Date
    October 24, 1997
    Manufacturer
    PHARMACIA & UPJOHN CO.
    Product Code
    LZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HEALON SYRINGE WAS LOADED W/NEEDLE & PLUNGER AS PER INSERT. WHEN PHYSICIAN INSERTED INTO EYE & DEPRESSED PLUNGER, A "BLACK HAIR WAS EXPELLED INTO THE EYE W/ THE HEALON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEALON 0.85ML VISCOELASTIC AID LZP PHARMACIA & UPJOHN CO. NA YF56359

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN