BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTPLUG

    MDR report key: 7138435 · Received December 20, 2017

    Report

    Report Number
    MW5074150
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    May 1, 2017
    Report Date
    December 19, 2017
    Manufacturer
    MEDENNIUM INC.
    Product Code
    LZU
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    SEEN BY OPHTHALMOLOGIST FOR FIRST EYE INFECTION. TREATED WITH VIGAMOX FOR 2 WEEKS. INFECTION RESOLVED, THEN RETURNED (B)(6). TRIED TO HAVE SMARTPLUGS IRRIGATED OUT. REFERRED TO OPTHAMOLIC PLASTIC SURGEON. NOW SCHEDULED FOR SURGICAL PROCEDURE TO SEE IF THE SMARTPLUGS ARE GONE AND TO RESOLVE THE RECURRENT CANALICULITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916021 SMARTPLUG PLUG PUNCTUM LZU MEDENNIUM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R