BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 1770205 · Received July 21, 2010

    Report

    Report Number
    1057129-2010-00015
    Event Type
    Injury
    Date Received
    July 21, 2010
    Date of Event
    July 2, 2010
    Report Date
    July 19, 2010
    Manufacturer
    POREX SURGICAL
    Product Code
    JOF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR THIS LOT WERE REVIEWED AND ALL PROCESSES, AND TEST CRITERIA ARE WITHIN THE MEDPOR IMPLANT SPECIFICATION.

    Description of Event or Problem · 1

    THE DOCTOR STATED THAT THE PT RECEIVED A MEDPOR SPHERE IMPLANT TEN YEARS AGO. THE DOCTOR REPORTED THAT THERE WERE SMALL BUMPS OF MEDPOR THAT ARE COVERED BY A THIN LAYER OF CONJUNCTIVA ON THE PT'S EYE. THE DOCTOR REPORTED THAT HE EXPLANTED THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT MEDPOR SURGICAL IMPLANTS BLOCK FORM JOF POREX SURGICAL NA 108090699

    Patients

    Seq Age Sex Outcome Treatment
    1 Other