BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 3231976 · Received July 15, 2013

    Report

    Report Number
    2028159-2013-01374
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THE INFUSION PORT DISLODGED FROM THE TROCAR DURING A RETINAL PROCEDURE. THE PROCEDURE WAS COMPLETED. THERE WAS NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327784 CUSTOM PAK CONVENIENCE KIT KYG ALCON - IRVINE TECHNOLOGY CTR CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCURUS 800CS FULL FUNCTION