BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 3040446 · Received April 3, 2013

    Report

    Report Number
    1644019-2013-00030
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS THE FIRST COMPLAINT REPORTED FOR THIS ISSUE. THE LOT SPECIFIC TO THIS EVENT IS NOT KNOWN; THEREFORE, LOT HISTORY AND DEVICE HISTORY RECORDS (DHR) REVIEW WAS NOT POSSIBLE. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS NOT KNOWN; A SAMPLE WAS NOT RETURNED FOR INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED A PT WITH A FIBER OBSERVED IN THE INCISION AT A POST OPERATIVE VISIT. THE SURGEON REMOVED THE FIBER DURING THE SAME VISIT. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136655 CUSTOM PAK CONVENIENCE KIT KYG ALCON - HOUSTON CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR