BEUDAMED
    FDA Adverse Event Other Summary report: N

    FORM FIT HYDROGEL CANALICULAR PLUG

    MDR report key: 1474594 · Received September 11, 2009

    Report

    Report Number
    2083373-2009-00002
    Event Type
    Other
    Date Received
    September 11, 2009
    Date of Event
    August 17, 2009
    Report Date
    September 11, 2009
    Manufacturer
    OASIS MEDICAL, INC.
    Product Code
    LZU
    PMA / PMN Number
    K040912
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF BATCH PRODUCTION AND STERILIZATION RECORDS SHOWS THAT THERE WERE NO REMARKABLE EVENTS, ANOMALIES OR DEVIATIONS DURING PRODUCTION OF FORM FIT HYDROGEL CANALICULAR PLUG, (B)(4), PRODUCT LOT NUMBER LH0409F. A TOTAL OF (B)(4) FORM FIT HYDROGEL CANALICULAR PLUGS, (B)(4), PRODUCT LOT NUMBER LH0409F WERE RELEASED AND DISTRIBUTED. THERE HAVE BEEN NO OTHER ADVERSE EVENTS REPORTED BY ANY OTHER USER/CUSTOMER INVOLVING PLUGS FROM (B)(4), LOT LH0409F. TWO EVENTS WERE REPORTED BY THIS USER/CUSTOMER, THE OTHER REPORT IS DOCUMENTED ON MFG. REPORT #2083373-2009-00001. THE PLUG WAS IRRIGATED FROM THE CANALICULAR, THE PATIENT WAS PRESCRIBED ANTIBIOTIC DROPS. THE ISSUE WAS RESOLVED FOR THE PATIENT, NO FURTHER TREATMENT WAS REQUIRED. (B)(4). CANNOT DEFINITIVELY DETERMINE THAT THE FORM FIT HYDROGEL CANALICULAR PLUG, (B)(4), FROM PRODUCT LOT NUMBER LH0409F WAS DIRECTLY OR INDIRECTLY RESPONSIBLE FOR THE REPORTED OBSERVATION OF CANALICULITIS.

    Description of Event or Problem · 1

    REPORTED OBSERVATION: PATIENT DEVELOPED CANALICULITIS IN THE LEFT EYE AFTER INSERTION OF AN OASIS MEDICAL FORM FIT HYDROGEL CANALICULAR PLUG. (B)(4). PRODUCT LOT NUMBER: LH0409F. PRODUCT INSERTED ON: (B)(6) 2009. DATE OF COMPLICATION: (B)(6) 2009. REPORTED TO (B)(4) ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORM FIT HYDROGEL CANALICULAR PLUG INTRACANALICULAR PLUG LZU OASIS MEDICAL, INC. 6303 LH0409F

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention