BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED BIO-EYE HA IMPLANT

    MDR report key: 1590825 · Received January 27, 2010

    Report

    Report Number
    2027377-2010-00001
    Event Type
    Injury
    Date Received
    January 27, 2010
    Date of Event
    July 29, 2009
    Report Date
    December 30, 2009
    Manufacturer
    INTEGRATED ORBITAL IMPLANTS
    Product Code
    HPZ
    PMA / PMN Number
    K003338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EXPOSURE IS AN ANTICIPATED COMPLICATION OF ORBITAL IMPLANT SURGERY. IT IS GENERALLY TREATED CONSERVATIVELY AND IS SURGICALLY CLOSED ONLY IN THE CASE OF LARGE EXPOSURES OR IF THE WOUND DOES NOT SPONTANEOUSLY CLOSE WITHIN A REASONABLE TIME PERIOD. IN THIS INSTANCE THE PHYSICIAN CONTACTED THE MANUFACTURER FOR ADVICE, AND SURGICAL CLOSURE OF THE EXPOSURE WAS SUGGESTED.

    Description of Event or Problem · 1

    PATIENT WAS EXPERIENCING EXPOSURE WITH IMPLANT. IMPLANT WAS REPLACED WITH NEW ONE AND PATIENT ALSO EXPERIENCED EXPOSURE WITH SUBSEQUENT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED BIO-EYE HA IMPLANT IMPLANT, EYE SPHERE HPZ INTEGRATED ORBITAL IMPLANTS I0018C 36307/63450

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention