BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 2913545 · Received December 21, 2012

    Report

    Report Number
    3002037047-2012-00179
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    November 27, 2012
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT RETURN A SAMPLE FOR EVALUATION. THE BATCH RECORD COULD NOT BE CHECKED AS THE CUSTOMER DID NOT PROVIDE A LOT NUMBER. A REVIEW OF THE COMPLAINT HISTORY IS NOT POSSIBLE TO INVESTIGATE. THE CUSTOM PAK LABEL INFORMS THAT DUE TO THE NATURE OF THE MATERIALS, FIBERS MAY BE PRESENT AND THAT NECESSARY PRECAUTIONS SHOULD BE TAKEN DURING SURGERY TO MINIMIZE THE RISK OF FIBERS ENTERING OR REMAINING IN THE EYE. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THAT FIBERS WERE FOUND IN THE PATIENT'S EYE DURING SURGERY. THE DOCTOR SUSPECTS THE FIBERS CAME FROM THE SURGICAL PAK. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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