BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 3910036 · Received February 25, 2014

    Report

    Report Number
    1644019-2014-00028
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    January 28, 2014
    Report Date
    January 30, 2014
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT LEAKAGE OCCURRED FROM A VALVED TROCAR CANNULA DURING SURGERY. NO HARM TO THE PATIENT WAS REPORTED, AND THE SURGERY WAS COMPLETED WITH ANOTHER PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117001 CUSTOM PAK CONVENIENCE KIT KYG ALCON - HOUSTON CUSTOM PAK 1500444H

    Patients

    Seq Age Sex Outcome Treatment
    1