BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 2912823 · Received January 9, 2013

    Report

    Report Number
    3002037047-2013-00004
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    May 1, 2012
    Report Date
    December 10, 2012
    Manufacturer
    ALCON- BELGIUM/ S.A. ALCON- COUVREUR N.V.
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE

    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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THIS IS THE FIRST OF THREE REPORTS FOR THIS FACILITY. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE CANNULA CAME LOOSE FROM THE SYRINGE DURING CATARACT SURGERY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLEEDING IN THE EYE AS A RESULT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11790 CUSTOM PAK CONVIENENCE KIT KYG ALCON- BELGIUM/ S.A. ALCON- COUVREUR N.V. CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other