BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 933694 · Received October 25, 2007

    Report

    Report Number
    1057129-2007-00018
    Event Type
    Injury
    Date Received
    October 25, 2007
    Date of Event
    October 15, 2007
    Report Date
    October 25, 2007
    Manufacturer
    POREX SURGICAL
    Product Code
    LZK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A REPRESENTATIVE FROM A DOCTOR'S OFFICE REPORTED THAT A PATIENT RECEIVED LEFT AND RIGHT MEDPOR MIDFACE CONTOUR IMPLANTS AND A MEDPOR NASAL DORSUM IMPLANT IN 2007. THE REPRESENTATIVE STATED THAT APPROXIMATELY TWO WEEKS AFTER THE SURGERY, THE PATIENT REPORTED TO THE DOCTOR THAT SHE HAD SERIOUS HIVES OVER HER ENTIRE BODY AND SWELLING IN THE FACE. THE DOCTOR REPORTED THAT THE PATIENT HAS AN UNUSUAL IDIOPATHIC URTICARIA THAT COULD HAVE BEEN A RESULT OF AN INABILITY TO METABOLIZE AN ANESTHETIC AGENT. THE DOCTOR STATED THAT THE PATIENT WENT TO AN ALLERGIST WHO STATED THAT THE PATIENT HAD NOT HAD AN ALLERGIC REACTION. THE DOCTOR REPORTED THAT THE AREA AROUND THE LEFT MEDPOR MIDFACE IMPLANT DEVELOPED AN INFECTION AND WAS TREATED WITH ABX. THE DOCTOR STATED THAT THE INFECTION DID NOT RESOLVE AND LEFT MEDPOR MIDFACE IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT FACIAL RECONSTRUCTION LZK POREX SURGICAL NA B044H14

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other