BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFT PLUG SILICONE PUNCTUM PLUG

    MDR report key: 1204819 · Received October 20, 2008

    Report

    Report Number
    2083373-2008-00004
    Event Type
    Other
    Date Received
    October 20, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 17, 2008
    Manufacturer
    OASIS MEDICAL, INC.
    Product Code
    LZU
    PMA / PMN Number
    K980437
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED OBSERVATION WAS VERBALLY REPORTED IN 2008 BY AN OASIS MEDICAL, INC. OEM CUSTOMER WHO HAD RECEIVED A REPORTED OBSERVATION FROM ONE OF THEIR CUSTOMERS. A QUESTIONNAIRE WAS FORWARDED TO THE CUSTOMER TO OBTAIN ADDITIONAL INFO. THE QUESTIONNAIRE WAS RECEIVED ON 09/30/2008. A REVIEW OF BATCH PRODUCTION AND STERILIZATION RECORDS SHOWS THAT THERE WERE NO REMARKABLE EVENTS, ANOMALIES OR NONCONFORMANCE'S DURING PRODUCTION OR STERILIZATION OF SOFT PLUG SILICONE PUNCTUM PLUG, LOT NUMBER LS0508U. A TOTAL OF SOFT PLUG SILICONE PUNCTUM PLUGS, FROM LOT NUMBER LS0508U WERE MANUFACTURED AND HAVE BEEN DISTRIBUTED. THERE HAVE BEEN NO OTHER REPORTED ADVERSE EVENTS FOR SOFT PLUG SILICONE PUNCTUM PLUGS, FROM LOT NUMBER LS0508U. CONCLUSION: AS A RESULT OF INVESTIGATION RESULTS, OASIS MEDICAL CANNOT DEFINITIVELY DETERMINE THAT SOFT PLUG SILICONE PUNCTUM PLUGS, FROM LOT NUMBER LS0508U WAS DIRECTLY OR INDIRECTLY RESPONSIBLE FOR THE REPORTED OBSERVATION OF CYSTITIS. ISSUES HAVE BEEN RESOLVED AT THIS TIME FOR THE PT.

    Description of Event or Problem · 1

    REPORTED OBSERVATION: PT DEVELOPED MUCUS AROUND THE RIGHT EYE-LID, LATER DIAGNOSED AS CYSTITIS, AFTER INSERTION OF AN OASIS MEDICAL, INC. SOFT PLUG SILICONE PUNCTUM PLUG. PRODUCT LOT NUMBER: LS0508U. PRODUCT INSERTED ON: 2008. DATE OF COMPLICATION: TWO DAYS LATER. REPORTED TO OASIS MEDICAL, INC., THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFT PLUG SILICONE PUNCTUM PLUG PUNCTUM PLUG LZU OASIS MEDICAL, INC. 6611 LS0508U

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention