BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 2231182 · Received August 26, 2011

    Report

    Report Number
    1644019-2011-00035
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KDD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. THE ROOT CAUSE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A PATIENT WAS DIAGNOSED WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS) ON THE FIRST POST OPERATIVE DAY. THERE WAS NO SIGN OF INFECTION. THE PATIENT WAS REPORTED TO BE IMPROVING WITH THE USE OF STEROIDS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT IS FOR THE FOURTH MEDICAL DEVICE ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention IOL:| PROVISC:| CUSTOM PAK:| VISCOAT: