BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 1013819 · Received March 14, 2008

    Report

    Report Number
    1644019-2008-00007
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 13, 2008
    Manufacturer
    ALCON - HOUSTON
    Product Code
    LRO
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVALUATION. A REVIEW OF THE COMPLAINT HISTORY FOR THE PAST TWO YRS SHOWS NO ADDITIONAL TASS REPORT WERE RECEIVED FROM THIS FACILITY. ALCON'S INVESTIGATION, "INVESTIGATION INTO INCREASED REPORTS OF TASS (TOXIC ANTERIOR SEGMENT SYNDROME)", CONCLUDED THERE IS NO EVIDENCE THAT TASS IS ASSOCIATED WITH THE USE OF AN ALCON PRODUCT. IN ADDITION, A TASS TASK FORCE, SPONSORED BY THE ASCRS AND UNDER THE LEADERSHIP OF DR (B)(6), MET ON AN ONGOING BASIS AND COMPILED DATA REGARDING THE INCREASED INCIDENCE OF TASS CASES. THE TASS TASK FORCE FINAL REPORT DATES (B)(6) 2006, FOUND NO CONCLUSIVE EPIDEMIOLOGIC DATA TO SUGGEST THAT ANY ONE PRODUCT WAS RESPONSIBLE FOR THE INCREASE IN TASS CASES THAT WERE REPORTED. CAREFUL ANALYSIS OF THE INFO PROVIDED DID NOT REVEAL A SINGLE CAUSE OR POINT SOURCE RELATED TO THIS TASS OUTBREAK. THEIR INVESTIGATION FAILED TO IDENTIFY EVIDENCE SUPPORTING AN ASSOCIATION BETWEEN A SHARED PRODUCT AND THE CASES OF TASS REPORTED. THEREFORE, THESE CONCLUSIONS ALLOW FOR THIS FILE TO BE CLOSED. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTED HE HAD 4 CASES OF TASS FROM YESTERDAY ALL FROM CATARACT PROCEDURES. HE WANTS TO CHECK ON THE PACK CONTENTS, TUBING, ETC. ADDITIONAL INFO RECEIVED ON 03/10/2008. THE PTS WERE TREATED WITH HIGH DOSAGES OF STEROIDS AND THE INFLAMMATION HAD RESOLVED. THE PTS ARE DOING WELL AND DID NOT REQUIRE ANY SURGICAL INTERVENTION FOR THIS ISSUE. THE SITE CONTACT STATED THAT THE COMMON DENOMINATOR FOR ALL CASES WAS THE ANSELL GLOVES, A NO ALCON PRODUCT. THEY HAVE SINCE DISCONTINUED USING THE GLOVES AND HAVE NOT HAD ANY FURTHER CASES OF TASS. FOR THE ADDITIONAL PTS, REFERENCE THE FOLLOWING MDR#S: 1644019-2008-00005, -00006, -00008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK SURGICAL PAK LRO ALCON - HOUSTON CUSTOM PACK NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention