BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BSS AND BSS PLUS ADMINISTRATION SET

    MDR report key: 262458 · Received February 9, 2000

    Report

    Report Number
    1644019-2000-00003
    Event Type
    Malfunction
    Date Received
    February 9, 2000
    Date of Event
    January 3, 2000
    Report Date
    January 10, 2000
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    KYG
    Removal / Correction Number
    1644019-011200-001R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED SET CONTINUES TO HAVE TOO SLOW A FLOW. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BSS AND BSS PLUS ADMINISTRATION SET OCULAR SURGICAL IRRIGATION DEVICE KYG ALCON LABORATORIES, INC. 0065082650 118980H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA