BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 4173912 · Received October 1, 2014

    Report

    Report Number
    1644019-2014-00177
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    January 1, 2014
    Report Date
    September 4, 2014
    Manufacturer
    ALCON - HOUSTON
    Product Code
    LRO
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THREE CASES OF ENDOPHTHALMITIS. THE CUSTOMER DOES NOT SUSPECT A SPECIFIC PRODUCT, HOWEVER A CULTURE WAS PERFORMED ON THE BSS (BALANCED SALT SOLUTION). SEVERAL ATTEMPTS HAVE BEEN MADE TO ACQUIRE ADDITIONAL INFORMATION PERTAINING TO THIS EVENT. NONE HAS BEEN RECEIVED AT THIS TIME. NO SAMPLE IS EXPECTED TO RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610731 CUSTOM PAK CONVENIENCE KIT LRO ALCON - HOUSTON CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BALANCED SALT SOLUTION