BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERAFIL AUGMENTATION IMPLANT

    MDR report key: 984001 · Received January 22, 2008

    Report

    Report Number
    3005940491-2008-00001
    Event Type
    Injury
    Date Received
    January 22, 2008
    Date of Event
    November 9, 2007
    Report Date
    January 22, 2008
    Manufacturer
    EVERA MEDICAL, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS A FEMALE. THE COMPANY LEARNED THAT SHE HAD THE DEVICE IMPLANTED IN BOTH LIPS IN 2007. THE DOCTOR USED SCISSORS DISSECTION AND A STAINLESS STEEL DELIVERY CANNULA TO PLACE THE DEVICE. ON APPROX ONE AND A HALF MONTHS LATER, THE PATIENT RETURNED TO THE DOCTOR AND HAD THE UPPER LIP DEVICE "TUCKED IN" AT THE ENDS (REVISION). THE PATIENT RETURNED ON THREE DAYS LATER FOR A FOLLOW UP VISIT. ON A WEEK LATER, THE PATIENT PRESENTED WITH DEVICE EXTRUDED FROM ONE END OF THE UPPER LIP AND THE DEVICE WAS REMOVED. THE DOCTOR REPORTED THAT HE THOUGHT HE HAD INITIALLY PLACED THE DEVICE DEEP ENOUGH. HE ALSO REPORTED THAT THERE WAS NO PATIENT INJURY AS A RESULT OF THE REMOVAL. THE DEVICE WAS INFLATED WHEN REMOVED. THE DOCTOR SUGGESTED THAT THE TAB ON THE DEVICE MAY HAVE CONTRIBUTED TO THE EVENT. EVERA CANNOT CONFIRM OR REJECT THIS HYPOTHESIS. THE COMPANY HAS CHANGED THE MANUFACTURING PROCESS IN ORDER TO FACILITATE THE MANUFACTURE OF DIFFERENT SHAPES OF THE DEVICES, WHICH HAS COINCIDENTALLY ELIMINATED THE TAB ALTOGETHER. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION BECAUSE EVERA MEDICAL FOUND OUT ABOUT THE EVENT WEEKS AFTER IT HAPPENED AND THE DEVICE HAD ALREADY BEEN DISCARDED BY THE DOCTOR. REVIEW OF PRODUCTION RECORDS SHOW THAT THE DEVICE MET ALL OTHER RELEASE CRITERIA. EVERA WILL CONTINUE TO MONITOR THE EVENT AND TAKE APPROPRIATE ACTION.

    Description of Event or Problem · 1

    PATIENT PRESENTED AT THE CLINIC IN 2007 WITH IMPLANT EXTRUDED AND IT WAS SUBSEQUENTLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERAFIL AUGMENTATION IMPLANT STERILE AUGMENTATION IMPLANT FTL EVERA MEDICAL, INC. NA 01041

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention