BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 3223740 · Received July 10, 2013

    Report

    Report Number
    3002037047-2013-00070
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ALCON - BELGIUM/ALCON N.V.
    Product Code
    CAZ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS. A SAMPLE IS EXPECTED, BUT HAS NOT YET BEEN RECEIVED FOR EVAL. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE PINK SLEEVE WAS DEFECTIVE AND WAS DIFFICULT TO PLACE ON THE TIP WITH THE HOLES CORRECTLY PLACED "FACE TO FACE" TO ALLOW CORRECT IRRIGATION AND ASPIRATION. TWO SURGEONS WERE UNABLE TO MOVE THE HANDPIECE IN THE EYE DURING TWO SURGERIES, AND THE HANDPIECE NEEDED TO BE REMOVED FROM THE EYE AND THE SLEEVE WAS EXCHANGED IN EACH CASE. THE INCISION SIZE WAS INCREASED IN BOTH PTS DUE OT THE MANIPULATION NECESSARY TO CHANGE THE SLEEVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316308 CUSTOM PAK CONVENIENCE KIT CAZ ALCON - BELGIUM/ALCON N.V. CUSTOM PAK 360499

    Patients

    Seq Age Sex Outcome Treatment
    1 Other INTREPID PLUS PAK 0.9MM ULTRA MF 30K