BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDPOR IMPLANT

    MDR report key: 1659087 · Received April 9, 2010

    Report

    Report Number
    1057129-2010-00009
    Event Type
    Other
    Date Received
    April 9, 2010
    Report Date
    April 8, 2010
    Manufacturer
    POREX SURGICAL
    Product Code
    JAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ITEM AND LOT NUMBER NOT PROVIDED TO ALLOW FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    THE DOCTOR STATED THAT THE PATIENT RECEIVED A MEDPOR PLUS IMPLANT. THE DOCTOR STATED THAT THE IMPLANT WAS DOING WELL, BUT A NEED FOR FURTHER SURGERIES FOR ORBITAL MALIGNANCY MEANT THAT THE IMPLANT HAD TO BE REMOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other