BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTPLUG

    MDR report key: 4397790 · Received December 23, 2014

    Report

    Report Number
    2031959-2014-00003
    Event Type
    Injury
    Date Received
    December 23, 2014
    Date of Event
    November 1, 2014
    Report Date
    December 22, 2014
    Manufacturer
    MEDENNIUM INC
    Product Code
    LZU
    PMA / PMN Number
    K022043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE REPORTED EVENTS WE CAN CONCLUDE THAT THE SMARTPLUGS WERE IMPLANTED IN THE PT'S UPPER PUNCTUM WITH NO PROBLEM. ONCE IMPLANTED IN THE LOWER PUNCTUM THERE WAS AN IMMEDIATE NEGATIVE RESPONSE BY THE PT SHOWING SIGNS OF PAIN, SWELLING AND EDEMA. THIS IS VERY RARE AS IT WAS NOT OBSERVED IN THE UPPER PUNCTUM TWO MONTHS PRIOR RULING OUT POTENTIAL ALLERGIC REACTION. THE IMMEDIATE NEGATIVE RESPONSE WHICH WAS MORE PROMINENT ON THE LOWER RIGHT LID LEADS US TO BELIEVE THAT THERE WAS PREVIOUS OBSTRUCTION (NSLO) WHICH WAS OVERCOME BY SIMPLE IRRIGATION OF THE LOWER LEFT LID BUT BECAME A PROBLEM ON THE RIGHT SIDE. THE NSLO WAS NOT CAUSED BY THE DEVICE AS IT PERSISTED AFTER ITS SURGICAL REMOVAL IN (B)(6) 2014 AND WAS ONLY RESOLVED AFTER PERFORMANCE OF DACRYOCYSTORHINOSTOMY IN (B)(6) OF 2014. SINCE THE PRODUCT WAS REMOVED WE DO NOT EXPECT ANY FURTHER PROBLEMS WITH THE PT. THIS CASE IS CLOSED AS NO ADDITIONAL INFORMATION CAN BE EXPECTED.

    Description of Event or Problem · 1

    IMPLANTATION OF SMARTPLUGS IN UPPER PUNCTUMS (B)(6) 2013 DUE TO MARKETED KERATITIS SICCA. LOWER PUNCTUMS (B)(6) 2013. NOTED PAIN SWELLING AND EDEMA OF LOWER LIDS IMMEDIATELY POST IMPLANTATION. RIGHT GREATER THAN LEFT. SUCCESSFULLY IRRIGATED LEFT SIDE, UNSUCCESSFUL ON THE RIGHT SIDE AFTER THREE ATTEMPTS. IN (B)(6) 2014 UNDERWENT SURGICAL RETRIEVAL OF THE RIGHT LOWER LID AND SUSTAINED SIGNIFICANT IRRITATION AND EPHIPHORA. (B)(6) 2014 UNSUCCESSFUL ATTEMPT AT (B)(6) TUBE PLACEMENT WAS TRIED AND SURGERY WAS CONVERTED TO A SUCCESSFUL DACRYOCYSTORHINOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849296 SMARTPLUG LZU MEDENNIUM INC 500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention