BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR SPHERE

    MDR report key: 568949 · Received January 27, 2005

    Report

    Report Number
    1057129-2005-00005
    Event Type
    Injury
    Date Received
    January 27, 2005
    Date of Event
    June 23, 2004
    Report Date
    December 30, 2004
    Manufacturer
    POREX SURGICAL
    Product Code
    HQH
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EMAIL FROM PT WHO RECEIVED AN ARTIFICIAL EYE MADE OF MEDPOR MATERIAL IN 1996. PT WAS EXPERIENCING UNCOMFORTABLE FEELING WITH BLOOD IN TEARS. IMPLANT WAS REMOVED IN AUGUST 2004. PT WAS CONTACTED AND HAD THE IMPLANT REMOVED AND WAS FEELING WELL, BUT DID NOT PROVIDE OTHER INFO. PRODUCT WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR SPHERE ARTIFICIAL EYE HQH POREX SURGICAL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention