BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 2198788 · Received January 19, 2007

    Report

    Report Number
    1057129-2007-00001
    Event Type
    Injury
    Date Received
    January 19, 2007
    Report Date
    January 18, 2007
    Manufacturer
    POREX SURGICAL
    Product Code
    JAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L CATALOG NUMBERS: 8328, 8329, 8329, 8330, 8330, 8330, 8331, 8331. ADD'L LOT NUMBERS: A284E11A(2), 002110104H, 104160904, 142150903A, A001E11A, A002D53H, 057181103A, 023160904. ADD'L EXPIRATION DATES: 05/2015, 01/2014, 09/2014, 09/2013, 05/2015, 04/2015, 11/2013, 09/2014. ADD'L MANUFACTURE DATES: 05/2005, 01/2004, 09/2004, 09/2003, 05/2005, 04/2005, 11/2003, 09/2004. IN THE PAST TWO YEARS, WE MANUFACTURED 1540 PIECES AND DISTRIBUTED 1202 PIECES OF THE EAR RIM IMPLANTS. OF THE 1202 PIECES DISTRIBUTED, THE COMPLAINT PERCENTAGE RATE FOR THE PAST TWO YEARS IS .0016. WE HAD ONE INCIDENT IN (B)(6) OF 2006 SIMILAR TO THIS ONE CONCERNING AN EXPOSED EAR RIM IMPLANT. THE MDR REPORTING NUMBER IS 1057129-2006-0014. ALL DEVICE HISTORY RECORDS WERE CHECKED FROM PROCESSING TO FINISHED GOOD AND ALL WERE WITHIN SPECIFICATION. A COPY OF THE CURRENT INSTRUCTIONS FOR USE AND LABELING ARE ENCLOSED. A PAPER "MICROTIA EAR RECONSTRUCTION PROCEDURE" BY (B)(6), M.D., F.A.C.S. IS ENCLOSED ALSO.

    Description of Event or Problem · 1

    A DOCTOR REPORTED TO OUR (B)(6) DISTRIBUTOR THAT IN THE PAST TWO YEARS, FIVE OF HIS PTS HAD AURICLE RECONSTRUCTION USING MEDPOR EAR IMPLANTS. THE FIVE PTS SUFFERED FROM PROBLEMS WITH SKIN NECROSIS, LOCAL EXTRUSIONS AND PAIN. THE DOCTOR STATED THAT HE REMOVED THE IMPLANTS FROM TWO OF THE PTS. HE PARTIALLY REMOVED THE IMPLANTS FROM THE REMAINING THREE PTS AND COVERED THE REMAINING PORTION OF THE IMPLANTS WITH LOCAL SKIN FLAPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT FACIAL RECONSTRUCTION JAZ POREX SURGICAL NA 0111260804H

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other