BEUDAMED
    FDA Adverse Event Other Summary report: N

    FORM FIT HYDROGEL CANALICULAR PLUG

    MDR report key: 1960266 · Received January 7, 2011

    Report

    Report Number
    2083373-2010-00004
    Event Type
    Other
    Date Received
    January 7, 2011
    Date of Event
    December 10, 2009
    Report Date
    January 7, 2011
    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

    THE DEVICE WAS NOT RETURNED FOR EVAL. SPECIFIC PRODUCT LOT INFO WAS NOT PROVIDED WITH THE INITIAL REPORT OF THE COMPLICATIONS. THE DATE OF PLUG INSERTION AND REMOVAL WAS NOT REPORTED WITH THE INITIAL REPORT OF COMPLICATIONS. THE ATTENDING DOCTOR WAS ABLE TO IRRIGATE THE PLUG FROM THE CANALICULUS. A REQUEST FOR CASE SPECIFIC INFO HAS BEEN REQUESTED FROM THE REPORTING DOCTOR. SUPPLEMENTAL INFO WILL BE SUBMITTED WHEN RECEIVED.

    Description of Event or Problem · 1

    REPORTED OBSERVATION: PT DEVELOPED CANALICULITIS AFTER INSERTION OF AN OASIS MEDICAL FORM FIT HYDROGEL CANALICULAR PLUG. (B)(4). PRODUCT LOT NUMBER: UNK. PRODUCT INSERTED ON: UNK. DATE OF COMPLICATION: REPORTED TO OASIS MEDICAL, INC. ON (B)(6) 2010. PT HAD NOTICEABLE PUSS AND INFLAMMATION, DOCTOR TREATED WITH ANTIBIOTICS. PT RETURNED AFTER TREATMENT AND THE DOCTOR WAS ABLE TO REMOVE THE PLUG FROM THE CANALICULUS, THE DOCTOR EXPRESSED CONCERNS FOR SCAR TISSUE WITH THIS PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other