BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 2436648 · Received January 18, 2012

    Report

    Report Number
    3002037047-2012-00012
    Event Type
    Malfunction
    Date Received
    January 18, 2012
    Report Date
    December 19, 2011
    Manufacturer
    ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING SURGERY, THE SURGEON TRIED TO MAKE AN INCISION WITH THE KNIFE FROM THE CONVENIENCE PACK, HOWEVER, "DOES NOT GET THROUGH", SINCE THE KNIFE IS BLUNT OR HAS A BURR. NO PT INJURY HAS BEEN REPORTED, AND NO PT IDENTIFIERS ARE AVAILABLE. THIS IS THE THIRD OF 16 REPORTS FROM THIS CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CLEARCUT HP2 DB SLIT 2.2MM ANG KNIFE