BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 1913659 · Received November 12, 2010

    Report

    Report Number
    1644019-2010-00097
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ALCON - HOUSTON
    Product Code
    LRO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTED: BLUE AND WHITE FIBERS FROM THE PAK APPEARING THROUGHOUT THE SURGICAL FIELD. NO PT IMPACT WAS REPORTED. ADDITIONAL INFO WAS REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1