BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDPOR IMPLANT

    MDR report key: 1400096 · Received June 4, 2009

    Report

    Report Number
    1057129-2009-00003
    Event Type
    Other
    Date Received
    June 4, 2009
    Date of Event
    May 1, 2009
    Report Date
    June 3, 2009
    Manufacturer
    POREX SURGICAL
    Product Code
    HPZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGERY COORDINATOR STATED THAT THE IMPLANT WAS IN GOOD CONDITION AFTER REMOVAL. FOLLOWING A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT NUMBER 6327-193160904, IT WAS DETERMINED THAT ALL PROCESSES AND TEST CRITERIA ARE WITHIN THE MEDPOR IMPLANT FINISHED PRODUCT SPECIFICATION.

    Description of Event or Problem · 1

    THE SURGICAL COORDINATOR STATED THAT THE PT RECEIVED A MEDPOR SPHERE IMPLANT IN (B)(6) 2005. THE COORDINATOR STATED THAT A SCLERA GRAFT WAS PERFORMED IN (B)(6) 2009, DUE TO IMPLANT EROSION. THE COORDINATOR REPORTED THAT IN (B)(6) 2009 THE AREA ONCE AGAIN SHOWED EROSION AND AN INFECTION. THE COORDINATOR REPORTED THAT IN (B)(6) 2009, THE IMPLANT WAS REMOVED AND AN ACRYLIC IMPLANT WAS PLACED. THE COORDINATOR REPORTED THAT THE PT IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT FACIAL RECONSTRUCTION HPZ POREX SURGICAL NA 193160904

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other