BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPAQUE HERRICK LACRIMAL PLUG

    MDR report key: 484858 · Received September 16, 2003

    Report

    Report Number
    2024818-2003-00004
    Event Type
    Injury
    Date Received
    September 16, 2003
    Date of Event
    June 5, 2003
    Report Date
    September 15, 2003
    Manufacturer
    LACRIMEDICS, INC.
    Product Code
    LZU
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT CONTACTED MANUFACTURER DIRECTLY. HAD PLUGS PUT IN ALL 4 PUNCTA IN 2002. EXPERIENCED EXCESSIVE TEARING BY FALL AND REQUESTED REMOVAL. INSERTING PHYSICIAN REMOVED ONE PLUG AND REFERRED PT TO ANOTHER, MORE EXPERIENCED DOCTOR WHO REMOVED THE OTHER LOWER PLUG. STILL HAS A PLUG IN THE LEFT UPPER. PT THEN CONTACTED ANOTHER PHYSICIAN THAT RECOMMENDED SURGERY. PT IS CURRENTLY PURSUING NON SURGICAL REMEDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPAQUE HERRICK LACRIMAL PLUG INTRACANLICULAR PLUG LZU LACRIMEDICS, INC. HLP3-OP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention