BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 3061152 · Received April 10, 2013

    Report

    Report Number
    1644019-2013-00034
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 15, 2013
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED, BUT HAS NOT YET BEEN EVALUATED. A LOT NUMBER WAS NOT SUPPLIED. A REVIEW OF THE DHR (DEVICE HISTORY RECORD) COULD NOT BE CONDUCTED. 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 THE TROCAR CANNULA WAS FOUND TO BE BENT DURING THE PROCEDURE. THE CASE WAS ABLE TO BE COMPLETED AFTER THE PRODUCT WAS REPLACED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149716 CUSTOM PAK CONVENIENCE KIT KYG ALCON - HOUSTON CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 CONSTELLATION LXT SYSTEM