BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTPLUG

    MDR report key: 2222483 · Received April 26, 2011

    Report

    Report Number
    2031959-2011-00001
    Event Type
    Other
    Date Received
    April 26, 2011
    Date of Event
    January 1, 2002
    Report Date
    April 25, 2011
    Manufacturer
    MEDENNIUM, INC.
    Product Code
    LZU
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE DATES IDENTIFIED ON THE ARTICLE WE ONLY SHOW SHIPPING RECORDS FROM 2002 TO 2005 OF A TOTAL OF (B)(4). IMPORTANT TO NOTE THAT NO MEDICAL TREATMENT WAS ATTEMPTED ON 6 OF THE 17 PATIENTS SO THE STATEMENT SHOULD READ ALL AFFECTED PATIENTS WERE TREATED BY CANALICULOTOMY AS THE TREATMENT OF CHOICE. THE LONG TERM STUDIES SUGGEST 3.9% FOR SILICONE HEADED PLUGS. CHEN SX, LEE GA 2007 REFERENCE NO. 10 IN THE HILL ARTICLE. SO IS THERE A SUBSTANTIAL DIFFERENCE IN THE RISKS OF CANALICULITIS WITH EITHER HEADED SILICONE PLUGS OR INTRACANALICULAR SMARTPLUGS? 3.9% SILICONE VS. 1.86% SMARTPLUG? REFERENCE NUMBER 7. THE SMARTPLUG STUDY GROUP HEADED BY JOSEPH MAURIELLO M.D. IN THIS ARTICLE AMONG 28 PATIENTS WITH DIAGNOSED COMPLICATIONS 9 OF THEM WERE SUCCESSFULLY TREATED WITHOUT THE NEED FOR SURGERY. THIS IS ABOUT 33%. IS THE BERSANI/HILL APPROACH TO RESOLVING COMPLICATIONS THE RIGHT APPROACH? IS IT TO PERFORM SURGERY WITHOUT ATTEMPTING TO RESOLVE THE SITUATION BY THE USE OF ANTIBIOTICS ORAL/TOPICAL WAITING FOR RESOLUTION OF INFECTION AND THEN ATTEMPTING IRRIGATION? ALSO IMPORTANT TO NOTE THAT BEFORE GIVING UP ON ANTIBIOTIC TREATMENT IT MAY BE HELPFUL TO STUDY IF THE ANTIBIOTIC BEING USED IS THE CORRECT ONE FOR THE TYPE OF BACTERIA BEING TREATED. THE PATIENTS HERE PRESENTED HAVE RESOLVED THEIR CANALICULITIS AND NO FURTHER REPORTS CAN BE EXPECTED. THIS REPORT IS CLOSED.

    Description of Event or Problem · 1

    (B)(4), MD ET ALL., "PREVALENCE OF CANALICULITIS REQUIRING SURGICAL REMOVAL OF SMART PLUGS", OPHTHALMIC PLASTIC RECONSTRUCTIVE SURGERY, VOL 25, NO6, 2009 WAS WRITTEN REGARDING SMART PLUG AND THE PREVALENCE OF CANALICULITIS IN ONE PRACTICE AS (B)(4). THE AVERAGE ONSET OF SYMPTOMS WAS AT 3 YEARS AND IN 3 CASES IN AS LITTLE AS 3, 4 AND 5 MONTHS, RESPECTIVELY. THE PLUGS WERE INSERTED FROM 2002 TO 2007. SEVENTEEN PATIENTS HAD SMART PLUG INSERTED AGES (B)(6), 15 FEMALE AND 2 MALE. TWO WERE IRRIGATED AND 7 RECEIVED TOPICAL ANTIBIOTICS. ONE RECEIVED TOPICAL AND ORAL ANTIBIOTICS. ONE RECEIVED ORAL ANTIBIOTICS ONLY. NO MEDICAL TREATMENT WAS ATTEMPTED IN 6 OF THE PATIENTS. CANALICULOTOMY WAS PERFORMED ON ALL PATIENTS. ONE PATIENT REQUIRED BILATERAL JONES TUBES DUE TO CHRONIC EPIPHORA. ONE PATIENT REQUIRED SILICONE INTUBATION FOR EPIPHORA. THE REPORTED OUTCOMES WERE THAT 9 RESOLVED, 4 HAD DRY EYE, 2 HAVING EPIPHORA ONE REQUIRING SILICONE INTUBATION AND ONE REQUIRING JONES TUBES. TWO HAD NO OUTCOMES LISTED ONE WITH NO MEDICAL TREATMENT ATTEMPTED AND ONE WITH TOPICAL ANTIBIOTICS ATTEMPTED. IT APPEARS THAT ALL PATIENTS WITH LISTED OUTCOMES HAD RESOLUTION OF THE CANALICULITIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention