BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 2202105 · Received August 5, 2011

    Report

    Report Number
    1644019-2011-00032
    Event Type
    Injury
    Date Received
    August 5, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADD'L INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT AND THE ROOT CAUSE IS, THEREFORE, UNK AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WHO PRESENTED WITH "POSITIVE" ENDOPHTHALMITIS ONE WEEK AFTER CATARACT SURGERY. THE PT WAS HOSPITALIZED AND TREATED WITH ANTIBIOTIC INJECTIONS IN THE RIGHT EYE. ADD'L INFO HAS BEEN REQUESTED. THIS IS THE THIRD REPORT OF FOUR MEDICAL DEVICE REPORTS FOR THIS FACILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R BALANCED SALT SOLUTION| PHACO TIP| DUOVISC