BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILIKON 1000 OIL

    MDR report key: 563282 · Received February 27, 2004

    Report

    Report Number
    1610287-2004-00004
    Event Type
    Other
    Date Received
    February 27, 2004
    Date of Event
    October 29, 2003
    Report Date
    January 30, 2004
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    LWL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT IS EXPERIENCING NUMBNESS AND KNOTS IN THEIR LIPS FOLLOWING INJECTION OF PRODUCT. PRODUCT WAS INJECTED IN 2003. THE NUMBNESS WAS FIRST NOTICED ON POSTOPERATIVE DAY 1, BUT BECAME MORE NOTICEABLE ON POSTOPERATIVE DAYS 2 AND 3. THE REPORTER STATES PT DISCUSSED THIS EVENT WITH THE FDA AND HAS SEEN SEVEN PHYSICIAN ABOUT THE REPORTED SYMPTOMS. NO TREATMENT HAS BEEN SUGGESTED WITH THE EXCEPTION OF REMOVAL OF THE PRODUCT. THE REPORTER IS HESITANT TO HAVE PRODUCT REMOVED DUE TO THEIR EXPERIENCED WITH THIS PROCEDURE. SYMPTOMS PERSIST AS OF 2/04. THE REPORTER WAS INFORMED THAT THIS PRODUCT IS NOT APPROVED NOR HAS THE CO CONDUCTED STUDIES FOR DERMATOLOGICAL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILIKON 1000 OIL INTRAOCULAR FLUID LWL ALCON LABORATORIES, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other