BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERA INTRANASAL SPLINT

    MDR report key: 898671 · Received August 17, 2007

    Report

    Report Number
    3005940491-2007-00001
    Event Type
    Injury
    Date Received
    August 17, 2007
    Date of Event
    November 10, 2006
    Report Date
    August 15, 2007
    Manufacturer
    EVERA MEDICAL, INC.
    Product Code
    LYA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO AN ADMINISTRATIVE OVERSIGHT, THIS REPORT IS BEING SUBMITTED LATE. THIS EVENT WAS DISCOVERED AS A MEDICAL MARKETING SPECIALIST WAS CONDUCTING A ROUTINE REVIEW OF FOLLOW UP VIDEOS FROM PTS ON OR AROUND IN 2007. THE VIDEO RECORDED REMOVAL OF A DEVICE FROM THE LOWER LIP OF A PT. THE DEVICES HAD BEEN IMPLANTED IN 2006 ON BOTH THE LOWER AND UPPER LIPS. THE REASON FOR REMOVAL WAS (PER THE DISTRIBUTOR FOR ANOTHER COUNTRY WHO FILMED THE DEVICE REMOVAL) THAT THE PT HAD REQUESTED REMOVAL AFTER THE IMPLANTATION SITE BECAME ITCHY AND SWOLLEN EIGHT WEEKS POST IMPLANTATION. INFORMATION OBTAINED FROM THE DOCTOR'S RECORDS INDICATED THAT "EXTERIORIZATION OF THE INFUSION PORT" NECESSITATED THE DEVICE REMOVAL, ALTHOUGH REPEATED FOLLOW-UP ATTEMPTS WITH THE DOCTOR TO OBTAIN HIS ADDITIONAL FEEDBACK HAVE BEEN UNSUCCESSFUL. THE DISTRIBUTOR CONFIRMED THAT THE PT WAS HAPPY WITH THE UPPER LIP AND THE DEVICE WAS LEFT IN PLACE. THE DEVICE WAS REMOVED 10 WEEKS POST IMPLANTATION IN 2007, AND THE PT WAS PRESCRIBED ANTIBIOTICS FOR TEN (10) DAYS. NO EVIDENCE OF INFECTION WAS DOCUMENTED. EXAMINATION OF PHOTOGRAPHS SUGGESTED THAT A DEHISCENCE HAD OCCURRED: THE TIP OF THE DEVICE WAS DIRECTLY UNDERLYING THE ACCESS INCISION AND IT APPEARED THAT THE ACCESS INCISION HAD NOT HEALED ADEQUATELY, EVENTUALLY OPENING OR DEHISCING OVER THE END OF THE DEVICE. TO THE BEST OF OUR KNOWLEDGE, THE PT HAS HAD NO FURTHER COMPLICATION AS A RESULT OF THE REMOVAL NOR FROM THE UPPER LIP THAT REMAINS IMPLANTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. LOT HISTORY RECORDS SHOW THE LOT MET ALL RELEASE REQUIREMENTS.

    Description of Event or Problem · 1

    THE EVENT WAS DISCOVERED DURING A ROUTINE REVIEW OF PT FOLLOW-UP VIDEO. A DEVICE HAD BEEN IMPLANTED INTO THE PT'S LOWER LIP. TEN WEEKS POST-IMPLANTATION, THE PT COMPLAINED OF ITCHINESS AND SWELLING IN HER LOWER LIP. THE DEVICE WAS REMOVED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVERA INTRANASAL SPLINT INTRANASAL SPLINT LYA EVERA MEDICAL, INC. NA 4128-091506

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention