BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 3963974 · Received May 8, 2014

    Report

    Report Number
    3002037047-2014-00060
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ALCON - BELGIUM/ ALCON N.V.
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. NO SAMPLES WERE RETURNED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED AND A LOT NUMBER WAS NOT INDICATED FOR THIS COMPLAINT; THEREFORE, THE DEVICE HISTORY RECORD (DHR) FOR THE LOT COULD NOT BE REVIEWED FOR ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. BECAUSE A SAMPLE WAS NOT RETURNED AND NO LOT NUMBER WAS INDICATED FOR THIS COMPLAINT, THE ROOT CAUSE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE TROCARS LEAKED DURING MULTIPLE PROCEDURES. PATIENT IMPACT IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278008 CUSTOM PAK CONVENIENCE KIT KYG ALCON - BELGIUM/ ALCON N.V. CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 CONSTELLATION VISION SYSTEM PAK