BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON 0.85ML

    MDR report key: 246652 · Received October 25, 1999

    Report

    Report Number
    MW1017419
    Event Type
    Malfunction
    Date Received
    October 25, 1999
    Date of Event
    October 11, 1999
    Report Date
    October 11, 1999
    Manufacturer
    PHARMACIA & UPJOHN CO.
    Product Code
    LZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    HEALON 0.85 ML FROM PHARMACIA-UPJOHN, AS THE PHYSICIAN WAS INJECTING HEALON INTO THE PT'S LEFT EYE A FOREIGN BODY CAME THROUGH THE HEALON CANNULA AND INTO THE PT'S OS. FOREIGN BODY WAS REMOVED BY THE SURGEON.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other