BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES TEN THOUSAND

    MDR report key: 15387 · Received January 14, 1994

    Report

    Report Number
    15387
    Event Type
    Injury
    Date Received
    January 14, 1994
    Date of Event
    September 23, 1993
    Report Date
    October 1, 1993
    Manufacturer
    ALCON SURGICAL, INC.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SERIES TEN THOUSAND OUTCOME I/A/PAK WAS BEING USED DURING PHACOEMULSIFICATION. ASPIRATION WAS NOT ADEQUATE LEADING TO ANTERIOR VITRECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TEN THOUSAND OUTCOME I/A PAK ALCON SURGICAL, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 84 * Hospitalization| R