BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVISC

    MDR report key: 1180546 · Received September 26, 2008

    Report

    Report Number
    3002037047-2008-00081
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    August 1, 2008
    Report Date
    September 17, 2008
    Manufacturer
    ALCON-BELGIUM / S.A. ALCON-COUVREUR N.V.
    Product Code
    LZP
    PMA / PMN Number
    P840064
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS WERE REVIEWED ALL DOCUMENTS INDICATED PRODUCT MET RELEASE CRITERIA. THERE ARE NO OTHER COMPLAINT REPORTED IN THIS LOT NUMBER. ADD'L INFO WAS REQUESTED ON 08/28/2008, 09/02/2008, 09/04/2008, 09/15/2008 BY PHONE; QUESTIONNAIRES WERE SENT ON 09/04/2008 BY OVERNIGHT COURIER. COMPLETED QUESTIONNAIRES HAVE NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A NURSE REPORTED THEIR FACILITY IS AVERAGING TWO TO FOUR CASES OF TASS WEEKLY. THEY ARE NOT BLAMING ANY PARTICULAR PRODUCT; THEY ARE TRYING TO RULE OUT ALL POSSIBLE CAUSES. ADD'L INFO HAS BEEN REQUESTED. THIS IS THE SECOND OF THREE MEDICAL DEVICE REPORTS BEING FILED FOR THIS REPORT. 3002037047-2008-00079- NO PT IDENTIFIERS. 3002037047-2008-00082- SECOND IDENTIFIED PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVISC AID, SURGICAL, VISCOELASTIC LZP ALCON-BELGIUM / S.A. ALCON-COUVREUR N.V. NA 08A16M

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention 0.2 ML VANCOMYCIN| EPINEPHRINE 1:1000| BSS WITH 0.5ML