BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTPLUG

    MDR report key: 1702902 · Received May 27, 2010

    Report

    Report Number
    MW5016136
    Event Type
    Injury
    Date Received
    May 27, 2010
    Date of Event
    January 1, 2007
    Report Date
    May 23, 2010
    Manufacturer
    MEDENNIUM, INC
    Product Code
    LZU
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    I HAVE HAD THREE CASES OF CHRONIC COLLICULITIS ON FEMALE PTS ON WHICH I PREVIOUSLY INSERTED PUNCTAL PLUGS FOR OCULAR DRYNESS. THE CANALICULITIS SEEMS ADVERSE TO TREATMENT, AND CAUSES CHRONIC PROBLEMS. ATTEMPTS TO FLUSH THE PLUG SEEM SUCCESSFUL, BUT PTS HAVE CHRONIC MUCOUS PRODUCTION FROM THEIR PUNCTA. IN ALL CASES, IT DEVELOPED AFTER AN EXTENDED PERIOD OF TIME FOLLOWING PLUG INSERTION. I FEEL THIS RATE IS UNACCEPTABLE AND THIS PRODUCT SHOULD BE DISCONTINUED. DATES OF USE: APPROX 2006. DIAGNOSIS OR REASON FOR USE: DRY EYE.

    Description of Event or Problem · 2

    I HAVE HAD THREE CASES OF CHRONIC COLLICULITIS ON FEMALE PTS ON WHICH I PREVIOUSLY INSERTED PUNCTAL PLUGS FOR OCULAR DRYNESS. THE CANALICULITIS SEEMS ADVERSE TO TREATMENT, AND CAUSES CHRONIC PROBLEMS. ATTEMPTS TO FLUSH THE PLUG SEEM SUCCESSFUL, BUT PTS HAVE CHRONIC MUCOUS PRODUCTION FROM THEIR PUNCTA. IN ALL CASES, IT DEVELOPED AFTER AN EXTENDED PERIOD OF TIME FOLLOWING PLUG INSERTION. I FEEL THIS RATE IS UNACCEPTABLE AND THIS PRODUCT SHOULD BE DISCONTINUED. DATES OF USE: APPROX 2006. DIAGNOSIS OR REASON FOR USE: DRY EYE.

    Description of Event or Problem · 3

    I HAVE HAD THREE CASES OF CHRONIC COLLICULITIS ON FEMALE PTS ON WHICH I PREVIOUSLY INSERTED PUNCTAL PLUGS FOR OCULAR DRYNESS. THE CANALICULITIS SEEMS ADVERSE TO TREATMENT, AND CAUSES CHRONIC PROBLEMS. ATTEMPTS TO FLUSH THE PLUG SEEM SUCCESSFUL, BUT PTS HAVE CHRONIC MUCOUS PRODUCTION FROM THEIR PUNCTA. IN ALL CASES, IT DEVELOPED AFTER AN EXTENDED PERIOD OF TIME FOLLOWING PLUG INSERTION. I FEEL THIS RATE IS UNACCEPTABLE AND THIS PRODUCT SHOULD BE DISCONTINUED. DATES OF USE: APPROX 2006. DIAGNOSIS OR REASON FOR USE: DRY EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTPLUG SMARTPLUG LZU MEDENNIUM, INC 500 MULTIPLE

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention
    2 40 YR
    3 44 YR