BEUDAMED
    FDA Adverse Event Other Summary report: N

    FORM FIT HYDROGEL CANALICULAR PLUG

    MDR report key: 2629648 · Received April 12, 2012

    Report

    Report Number
    2083373-2012-00001
    Event Type
    Other
    Date Received
    April 12, 2012
    Date of Event
    March 12, 2012
    Report Date
    April 11, 2012
    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

    PT DEVELOPED CANALICULITIS WITH GRANULOMA OS LOWER LID IN THE LEFT EYE REQUIRING SURGICAL TREATMENT. 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 PT WAS REFERRED TO AN OCULOPLASTIC SURGEON. THE SURGEON SURGICALLY REMOVED THE GRANULOMA AND WHAT APPEARED TO BE A RESIDUAL PLUG. THE ISSUE WAS RESOLVED FOR THE PT. THE PT HAD AN OASIS MEDICAL FORM FIT HYDROGEL PLUG INSERTED INTO BOTH THE RIGHT AND LEFT CANALICULUS. THE PT HAS HAD NO ADVERSE EVENT IN THE RIGHT LOWER PUNCTA/NASOLACRIMAL DUCT.

    Description of Event or Problem · 1

    REPORTED OBSERVATION: PT DEVELOPED CANALICULITIS AFTER INSERTION OF AN OASIS MEDICAL FORM FIT HYDROGEL CANALICULAR PLUG IN THE LEFT EYE. PRODUCT REFERENCE: 6306, PRODUCT LOT NUMBER: NOT REPORTED, PRODUCT INSERTED ON: (B)(6) 2011, DATE OF COMPLICATION: (B)(6) 2012, REPORTED TO OASIS MEDICAL INC ON: (B)(4) 2012. PT TREATED BY ATTENDING DR WITH ANTIBIOTICS. ATTENDING DR WAS UNABLE TO IRRIGATE THE PLUG FROM THE CANALICULUS. PT REFERRED TO AN OCULOPLASTIC SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORM FIT HYDROGEL CANALICULAR PLUG INTRACANALICULAR PLUG LZU OASIS MEDICAL, INC. 6303 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other