BEUDAMED
    FDA Adverse Event Other Summary report: N

    FORM FIT HYDROGEL CANALICULAR PLUG

    MDR report key: 3284646 · Received August 5, 2013

    Report

    Report Number
    2083373-2013-00002
    Event Type
    Other
    Date Received
    August 5, 2013
    Date of Event
    July 9, 2013
    Report Date
    August 1, 2013
    Manufacturer
    OASIS MEDICAL, INC.
    Product Code
    LZU
    PMA / PMN Number
    K040912
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: PATIENT DEVELOPED CHRONIC CANALICULITIS IN THE LEFT EYE. PRODUCT REFERENCE: 6303. PRODUCT LOT NUMBER: LH0810A. PRODUCT INSERTED ON: (B)(6) 2011. DATE OF COMPLICATION: (B)(6) 2012. REPORTED TO OASIS MEDICAL, INC. ON (B)(6) 2013. DISCUSSION: ATTEMPTS MADE TO FLUSH THE PLUG FROM THE CANALICULUS WERE UNSUCCESSFUL. THE CANALICULUS WAS NOT CHECKED FOR PATENCY PRIOR TO INSERTION OF THE OASIS MEDICAL FORM FIT HYDROGEL PLUG. AFTER THE ATTEMPTED CANALICULAR FLUSH AND TOPICAL ANTIBIOTIC THERAPY WAS UNSUCCESSFUL THE PATIENT WAS REFERRED TO AN OCULOPLASTIC SURGEON. THE SURGEON SURGICALLY REMOVED THE GRANULOMA AND WHAT APPEARED TO BE A RESIDUAL PLUG. CULTURE OF THE REMOVED DEVICE SHOWED ACTINOMYCES ISRAELII. THE ISSUE WAS RESOLVED FOR THE PATIENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO CONCLUSION CAN BE DRAWN AS TO THE DIRECT CAUSE OF THE REPORTED ADVERSE EVENT.

    Description of Event or Problem · 1

    REPORTED OBSERVATION: PATIENT DEVELOPED CHRONIC CANALICULITIS AFTER INSERTION OF AN OASIS MEDICAL FORM FIT HYDROGEL CANALICULAR PLUG IN THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366519 FORM FIT HYDROGEL CANALICULAR PLUG INTRACANALICULAR PLUG LZU OASIS MEDICAL, INC. 6303 LH0810A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other