BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 1040487 · Received May 9, 2008

    Report

    Report Number
    3002037047-2008-00024
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 9, 2008
    Manufacturer
    S.A. ALCON- COUVREUR N.V., ALCON - BELGIUM
    Product Code
    KYG
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, A SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE SURGEON REPORTED 2 CASES OF SANDS OF SAHARA (SOS) SYNDROME. THE SURGEON SUSPECTS THE SURGICAL SPEARS. PT TREATED WITH DEXAMETHASONE, NEOMYCIN (AS PREVENTIVE TREATMENT). CELESTENE (BETAMETHASON), TOBRADEX EVERY HOUR SINCE THE SECOND SURGERY. VISUAL ACUITY AT D+1: 1/10. PRESENCE OF DIFFUSE OPACITIES. ON 04/23/2008 CONFIRMED THAT A SECOND SURGERY HAD ALREADY DONE AT D+1. REFRACTIVE CONSEQUENCES UNK FOR THE MOMENT. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK SURGICAL PAK KYG S.A. ALCON- COUVREUR N.V., ALCON - BELGIUM CUSTOM PACK 188941

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention