BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 2052557 · Received April 8, 2011

    Report

    Report Number
    1644019-2011-00013
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A PT HAD BLUE FIBERS IN HIS EYE, POSTOPERATIVELY. THE PT RETURNED TO THE OPERATING ROOM AND THE FIBERS WERE REMOVED. NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK CONVENIENCE KIT KYG ALCON - HOUSTON CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention