BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 1940518 · Received December 17, 2010

    Report

    Report Number
    1644019-2010-00103
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 25, 2010
    Report Date
    November 24, 2010
    Manufacturer
    ALCON-HOUSTON
    Product Code
    LRO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE IS EXPECTED TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION BUT HAS NOT YET ARRIVED. 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 BLUE PARTICLES WERE SEEN IN THE ANTERIOR CHAMBERS OF TWO PATIENTS. THE PARTICLES WERE ASPIRATED OUT THE SAME DAY. IT WAS REPORTED THAT THERE WAS NO HARM OR INJURY TO ANY PATIENTS. NO PATIENT IDENTIFIERS WILL BE PROVIDED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK CONVENIENCE KIT LRO ALCON-HOUSTON CUSTOM PAK 1074769H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK