BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 3932826 · Received March 11, 2014

    Report

    Report Number
    1644019-2014-00039
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Date of Event
    January 16, 2014
    Report Date
    February 11, 2014
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STILL WAITING FOR THE COMPLAINT SAMPLE FOR DECONTAMINATION AND EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE LOT NUMBER IDENTIFIED WITH THIS COMPLAINT WILL BE RESEARCHED. A FINAL DETERMINATION OF WHETHER OR NOT A PRODUCT MALFUNCTION OCCURRED WILL BE MADE AT THE CONCLUSION OF THE INVESTIGATION AFTER THE SAMPLE HAS BEEN EVALUATED. A ROOT CAUSE HAD NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A DULL KNIFE DURING SURGERY THAT COULD NOT BE USED. THE KNIFE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146359 CUSTOM PAK CONVENIENCE KIT KYG ALCON - HOUSTON CUSTOM PAK 1497789H

    Patients

    Seq Age Sex Outcome Treatment
    1 CLEARCUT HP2 SLIT KNIFE