BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 2171407 · Received June 30, 2011

    Report

    Report Number
    1644019-2011-00030
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Report Date
    May 31, 2011
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES HAVE NOT BEEN RECEIVED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT WAS REVIEWED. FUNCTIONAL PENETRATION AND SHARPNESS TEST VALUES FOR THE LOT MET SPECIFICATION. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO A BLUNT KNIFE WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO COMPANY'S ACCEPTANCE CRITERIA. A ROOT CAUSE WAS NOT IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED, THE KERATOME USED TO MAKE THE MAIN INCISION WAS FOUND TO BE BLUNT. A SECOND KERATOME WAS USED TO COMPLETE THE INCISION WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK CONVENIENCE KIT KYG ALCON - HOUSTON CUSTOM PAK 831037M

    Patients

    Seq Age Sex Outcome Treatment
    1 CLEARCUT HP 2.8MM KNIFE