BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTPLUG

    MDR report key: 532847 · Received July 2, 2004

    Report

    Report Number
    2031959-2004-00013
    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
    OTHER

    Narratives

    Description of Event or Problem · 1

    "THE DOCTOR EXPLAINED HE THOUGHT HE HAD A CASE WHERE HE INSERTED SMARTPLUG, BILATERALLY, AND THE PT RETURNED 1-2 MONTHS POST INSERTION AND PRESENTED WITH PUS, SWELLING AND HEAT TO THE PUNCTAL REGION. THE DOCTOR PUT THE PT ON ORAL KEFLEX 250 MG FOR 7 DAYS AND THE POTENTIAL INFECTION RESOLVED. 1 WEEK POST RESOLUTION, THE PT CAME IN AND THE SAME SIGNS WERE BACK. THE DOCTOR PUT THE PT ON A Z-PACK AND THE POTENTIAL INFECTION RESOLVED. THE PLUGS WERE NOT IRRIGATED OUT AND THE PT IS CURRENTLY SYMPTOM FREE."

    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