BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR OCULAR SCREW AND ACCESSORIES

    MDR report key: 1877606 · Received October 15, 2010

    Report

    Report Number
    1057129-2010-00016
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    June 11, 2008
    Report Date
    August 9, 2010
    Manufacturer
    POREX SURGICAL
    Product Code
    MQU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INFO WAS NOT PROVIDED BY THE OCULARIST; THEREFORE AN INVESTIGATION COULD NOT BE CONDUCTED ON THE DEVICE.

    Description of Event or Problem · 1

    THE OCULARIST STATED THAT HE SAW THE PT FOR FITTING OF PROSTHESIS TO THE RIGHT EYE USING THE MEDPOR ATTRACTOR COUPLING SYSTEM ON (B)(6) 2007. THE OCULARIST TOOK IMPRESSION USING THE AQUASIL ULTRA L.V. THE DOCTOR STATED THAT THE POSITION OF THE ATTRACTOR WAS VISIBLE, ALTHOUGH NOT CLEARLY. THE OCULARIST STATED THAT HE PLACED THREE MAGNETS IN THE PROSTHESIS WITH GOOD RESULTS ON (B)(6) 2007. THE OCULARIST STATED THAT THE PT PRESENTED WITH UPPER-LID PTOSIS ON (B)(6) 2007. THE OCULARIST STATED THAT THE UPPER-LID PTOSIS WAS CORRECTED BY BULKING UP CORNEAL AREA. THE OCULARIST STATED THAT THE PTOSIS WAS DUE TO DECREASE IN SWELLING. THE OCULARIST STATED THAT THE SOCKET WAS SLIGHTLY INJECTED AFTER REMOVAL OF SOME OF THE STITCHES AND THE PLASTIC OVER THE MAGNETS AND THE CONJUNCTIVA AT THE MAGNET SITE WERE NOT DAMAGED. THE OCULARIST REPORTED THAT ON (B)(6) 2008, THE PT PRESENTED WITH EXPOSURE OF 15MM. THE OCULARIST STATED THAT SOME DEEPER STITCHES WERE REMOVED TWO WEEKS PRIOR TO THE EXPOSURE AND THE DOCTOR PRESCRIBED MAXITROL AND ACULAR. THE OCULARIST REPORTED THAT HE REMOVED THE MAGNET FROM THE PROSTHESIS BUT IT RESULTED IN INFERIOR LATERAL DECENTRATION. THE OCULARIST REPORTED THAT HE RESTARTED NEW PROSTHESIS. IMPRESSION TAKEN WITH THE AQUASIL ULTRA XLV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR OCULAR SCREW AND ACCESSORIES MEDPOR OCULAR SCREW AND ACCESSORIES MQU POREX SURGICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other