BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTRUE MULTI-PURPOSE SOLUTION

    MDR report key: 1600638 · Received February 5, 2010

    Report

    Report Number
    1313525-2010-00001
    Event Type
    Injury
    Date Received
    February 5, 2010
    Date of Event
    January 13, 2010
    Report Date
    January 13, 2010
    Product Code
    LYL
    PMA / PMN Number
    K083757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL AND THE LOT NUMBER INFO WAS NOT AVAILABLE. DOCTOR DOES NOT RELATE EVENT TO SOLUTION NOR CONTACT LENS WEAR. BASED ON ALL INFO, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PT PRESENTED WITH SORE, SWOLLEN UPPER RIGHT EYELID. DOCTOR DIAGNOSED PRE-SEPTAL CELLULITIS AND TREATED WITH ORAL ANTIBIOTICS. NINE DAYS LATER AT FOLLOW UP VISIT, PT FULLY RESOLVED WITH NO FURTHER TREATMENT NOR FOLLOW UP REQUIRED. PT RESUMED CONTACT LENS WEAR. DOCTOR CONCLUDED THIS EVENT WAS CAUSED BY EXPOSURE TO BACTERIA POSSIBLY A HEAD COLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOTRUE MULTI-PURPOSE SOLUTION LYL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CIBA VISION NIGHT AND DAY CONTACT LENSES