BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 2187877 · Received July 28, 2011

    Report

    Report Number
    2027377-2011-00002
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    May 11, 2010
    Report Date
    June 28, 2011
    Manufacturer
    UNK
    Product Code
    HPZ
    PMA / PMN Number
    K003338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER HAS BEEN ON EXTENDED LEAVE SINCE REPORTING THIS INCIDENT. WE HAVE THEREFORE BEEN UNABLE TO OBTAIN FURTHER INFO REGARDING THE ORIGINAL IMPLANT, THE INFECTION, AND THE REASON FOR REMOVING THE ORIGINAL IMPLANT. IF ADD'L INFO RELEVANT TO THE CAUSE OR OUTCOME OF THIS EVENT BECOME AVAILABLE WE WILL FILE AN ADD'L INFO REPORT.

    Description of Event or Problem · 1

    INFECTION NECESSITATING REMOVAL OF THE IMPLANT. PER THE REPORTER, THE PT PRESENTED TO THE CLINIC WITH AN INFECTION OF A PREVIOUSLY IMPLANTED ORBITAL IMPLANT. THERE IS NO INFO CURRENTLY AVAILABLE REGARDING THE ORIGINAL IMPLANTATION DATE, THE BRAND AND TYPE OF IMPLANT, OR THE REASON FOR THE INFECTION. THE IMPLANT WAS SURGICALLY REMOVED AND WAS REPLACED WITH A COATED BIO-EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN IMPLANT, EYE SPHERE, HPZ HPZ UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention