BEUDAMED
    FDA Adverse Event Other Summary report: N

    FORM FIT HYDROGEL CANALICULAR PLUGS

    MDR report key: 1290892 · Received December 5, 2008

    Report

    Report Number
    2083373-2008-00005
    Event Type
    Other
    Date Received
    December 5, 2008
    Date of Event
    September 18, 2008
    Report Date
    October 17, 2008
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF BATCH PRODUCTION AND STERILIZATION RECORDS SHOWS THAT THERE WERE NO REMARKABLE EVENTS, ANOMALIES OR NONCONFORMANCE'S DURING PRODUCTION OF FORM FIT HYDROGEL CANALICULAR PLUG, LOT NUMBER LH1006B. THIS IS THE ONLY CUSTOMER WHO HAS REPORTED ANY ADVERSE EVENTS FROM THIS LOT. CONCLUSION: AS A RESULT OF INVESTIGATION RESULTS, OASIS MEDICAL CANNOT DEFINITIVELY DETERMINE THAT FORM FIT HYDROGEL CANALICULAR PLUG, LOT NUMBER LH1006B WAS DIRECTLY OR INDIRECTLY RESPONSIBLE FOR THE REPORTED OBSERVATION OF CANALICULITIS. ISSUES HAVE BEEN RESOLVED AT THIS TIME FOR THE PT. CORRECTION TO INITIAL REPORTED ISSUED DUE TO A DUPLICATION OF MFR REPORT 3. CHANGED MFR REPORT # FROM 2083373-2008-00001 TO 2083373-2008-00005.

    Description of Event or Problem · 1

    AS REPORTED BY A DR, A PT DEVELOPED CANALICULITIS AFTER INSERTION OF AN OASIS MEDICAL, INC. FORM FIT HYDROGEL CANALICULAR PLUG. REPORTED OBSERVATION: PT DEVELOPED CANALICULITIS ON THE LEFT LOWER LID AFTER INSERTION OF AN OASIS MEDICAL, INC. FORM FIT HYDROGEL CANALICULAR PLUG. PRODUCT LOT NUMBER: LH1006B, PRODUCT INSERTED IN 2007, DATE OF COMPLICATION: 2008, REPORTED TO OASIS MEDICAL, INC TWO WEEKS FOLLOWING COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORM FIT HYDROGEL CANALICULAR PLUGS INTRACANALICULAR PLUG LZU OASIS MEDICAL, INC. 6303 LH1006B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention