BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 949045 · Received November 14, 2007

    Report

    Report Number
    1057129-2007-00016
    Event Type
    Injury
    Date Received
    November 14, 2007
    Date of Event
    January 23, 2007
    Report Date
    November 14, 2007
    Manufacturer
    POREX SURGICAL, INC.
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR THIS LOT WERE REVIEWED AND ALL PROCESSES AND TEST CRITERIA HAVE BEEN VERIFIED AS COMPLYING WITH THE MEDPOR IMPLANT SPECIFICATION.

    Description of Event or Problem · 1

    THE PT STATED THAT HE RECEIVED A MEDPOR NASAL IMPLANT IN 2002 AND NOW HAS WHAT SEEMS TO BE STRANDS OF THE IMPLANT COMING OUT OF HIS NOSE. THE PT STATED THAT SINCE ABOUT A MONTH AFTER THE SURGERY, HE HAS HAD PUSS AND BLOOD LEAKING FROM THE INSIDE NOSTRIL AREA DAILY. THE PT STATED THAT HE FINALLY WENT BACK TO THE DOCTOR 1-1/2 YEARS AFTER THE IMPLANT WAS IMPLANTED AND THE DOCTOR CUT OFF THE STRANDS THAT WERE COMING THROUGH THE INSIDE LEFT NOSTRIL. THE DOCTOR STATED THAT THE PT WAS EXAMINED POST OP IN LATE THE SAME YEAR AND HAD GOOD PROJECTION. THE DOCTOR REPORTED THAT THE PT WAS EXAMINED IN 2003 AND WAS REPORTED TO HAVE EXCELLENT AIRWAY AND THE PT INFORMED THE DOCTOR THAT HIS NOSE WAS FINE. THE DOCTOR STATED THAT THE PT WAS EXAMINED IN 2005 AND AT THAT TIME; THE DOCTOR REPORTED THAT THE PT STATED THAT HE COULD FEEL SOMETHING DANGLING FROM HIS NOSE AND HE HAD SOME SORE SPOTS. THE DOCTOR STATED THAT THE PT HAD SOME TENDERNESS BUT THERE WAS NO EXTRUSIONS. THE DOCTOR REPORTED THAT THE PT WAS EXAMINED IN 2006, AND THERE WAS NO BACTERIA GROWTH. THE DOCTOR REPORTED THAT THE PT WAS EXAMINED IN 2007 AND REQUESTED TO HAVE A SMALL PIECE OF THE IMPLANT TRIMMED BECAUSE HE COULD FEEL IT IN THE APEX OF THE LEFT NARE. THE DOCTOR STATED THAT HE TRIMMED THE CORNER OF THE MEDPOR IMPLANT THROUGH THE SKIN OPENING. HE CLEANED THE AREA WITH BETADINE AND TREATED WITH BACTROBAN OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT FACIAL RECONSTRUCTION FTM POREX SURGICAL, INC. NA 075110802

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other