BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTPLUG

    MDR report key: 532848 · Received July 2, 2004

    Report

    Report Number
    2031959-2004-00011
    Event Type
    Other
    Date Received
    July 2, 2004
    Report Date
    July 1, 2004
    Manufacturer
    MEDENNIUM, INC.
    Product Code
    LZU
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    "THE DOCTOR STATED SHE HAD A PT WHO RETURNED SYMPTOMATIC FOR CANALICULITIS AS EVIDENCED BY DISCHARGE, MUCOUS, PUS EXTRUDED. THE PHYSICIAN IRRIGATED THE PLUG OUT. THE PT WAS PUT ON "ANTIMOXI" AND THE INFECTION HAS RESOLVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTPLUG PUNCTUM PLUG LZU MEDENNIUM, INC. MODEL 500 UNK, NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other