BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 2500193 · Received March 21, 2012

    Report

    Report Number
    1644019-2012-00019
    Event Type
    Injury
    Date Received
    March 21, 2012
    Report Date
    February 22, 2012
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS ONE OF FOUR COMPLAINTS REPORTED FOR THIS ISSUE. THE LOT SPECIFIC TO THIS EVENT IS NOT KNOWN; THEREFORE, LOT HISTORY AND DHR REVIEW NOT POSSIBLE. A SAMPLE WAS NOT RETURNED FOR INVESTIGATION. THE ROOT CAUSE IS NOT KNOWN. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A PATIENT PRESENTED WITH A POSTOPERATIVE EYE INFECTION WHICH THEY CONFIRMED TO BE TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THERE HAS BEEN NO FURTHER INFORMATION RECEIVED AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED. THIS IS THE SECOND OF FOUR 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 Other SN60WF