BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 539092 · Received August 12, 2004

    Report

    Report Number
    2024818-2004-00005
    Event Type
    Injury
    Date Received
    August 12, 2004
    Report Date
    July 12, 2004
    Manufacturer
    LACRIMEDICS, INC.
    Product Code
    LZU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT CLAIMS TO HAVE RECEIVED PLUGS IN 2002. STARTED SUFFERING EXCESSIVE TEARING & IRRITATION. WAS TREATED WITH ANTIBIOTICS. THIS REDUCED SYMPTOMS. DR ATTEMPTED TO IRRIGATE PLUGS OUT AND WAS SUCCESSFUL IN 3 OF 4 DUCTS. WENT TO A SECOND DR WHO ALSO FAILED TO IRRIGATE OUT PLUG. THEN WENT TO A SURGEON WHO TOLD PT THE PLUG WAS IMBEDDED IN THE LACRIMAL SACK WITH SCAR TISSUE AROUND IT. HE PERFORMED SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK INTRACANILICULAR PLUG LZU LACRIMEDICS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention