BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTPLUG

    MDR report key: 496039 · Received November 10, 2003

    Report

    Report Number
    2031959-2003-00045
    Event Type
    Other
    Date Received
    November 10, 2003
    Report Date
    November 7, 2003
    Manufacturer
    MEDENNIUM, INC.
    Product Code
    LZU
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    "DR. STATED HE BELIEVED HE HAD A PATIENT WITH AN ALLERGIC REACTION TO THE PLUG. THIS PATIENT CAME TO HIS OFFICE, HAD THE SMARTPLUGS INSERTED IN THE INFERIOR CANALICULI AND 4 DAYS LATER RETURNED COMPLAINING OF SEVERE PAIN IN THE LIDS. EXAMINATIONS REVEALED NO ABNORMALITIES ON THE EXTERNAL EXAM. THIS PATIENT HAS A HISTORY OF "LOTS" OF ALLERGIES. THE PATIENT WAS REFERRED TO FAMILY DOCTOR AND WAS PRESCRIBED PREDNISONE. THE PREDINSONE TEMPORARILY MADE THE SYMPTOMS DISAPPEAR, BUT WHEN THE PATIENT WAS TAPERED OFF THE MED, THE SYMPTOMS REAPPEARED. THE FAMILY DOCTOR RECOMMENDED THEY RETURN TO DR. AND HAVE THE PLUGS REMOVED. DR SUCCESSFULLY REMOVED THE PLUGS AND HAS NOT SEEN THE PATIENT SINCE THIS TIME. THE PATIENT DID REPORT, DURING THE IRRIGATION, THAT THEY HAD A "VIOLENT" REACTION 2 YEARS AGO WHEN ACRYLIC NAILS PUT ON FINGERS."

    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| R