BEUDAMED
    FDA Adverse Event Other Summary report: N

    VERAFIL AUGMENTATION IMPLANT

    MDR report key: 1034674 · Received April 25, 2008

    Report

    Report Number
    3005940491-2008-00002
    Event Type
    Other
    Date Received
    April 25, 2008
    Date of Event
    November 1, 2007
    Report Date
    April 23, 2008
    Manufacturer
    EVERA MEDICAL, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN 2007, THE PATIENT WAS FOUND TO BE A GOOD CANDIDATE FOR THE IMPLANT BY THE SURGEON AND WAS SCHEDULED FOR AUGMENTATION SURGERY THE FOLLOWING MONTH. THREE DAYS LATER, THE PATIENT PRESENTED FOR FOLLOW UP CLAIMING SHE FELT BETTER BUT THOUGHT THE IMPLANTS PLACED IN LIP HAD SHIFTED TO THE LEFT. THE DOCTOR EXAMINED HER AND CONCLUDED THERE WAS NO EVIDENCE OF SHIFTING OF THE IMPLANT. HE ALSO NOTED AT THAT TIME THAT THERE WAS MODERATE SWELLING OF BOTH LIPS. FOLLOW UP WAS SCHEDULED IN TEN DAYS. FIVE DAYS LATER, PATIENT PRESENTED FOR FOLLOW UP AND STATED THAT HER LEFT SIDE WAS MORE SWOLLEN THAN THE RIGHT AND SAID SHE HAD PUS COMING FROM HER LOWER LIP ON THE LEFT SIDE. THE SURGEON NOTED THERE WAS MILD SWELLING OF THE LOWER LIP AND POSITIVE DISCHARGE FROM THE LOWER LIP INCISION SITE. A CULTURE WAS TAKEN FOR ANTIBIOTIC SENSITIVITY. THE SURGEON SUBSEQUENTLY PRESCRIBED AUGMENTIN AND AVELOX AND RECOMMENDED FOLLOW UP IN TEN DAYS. TWO DAYS LATER, PATIENT PRESENTED FOR FOLLOW UP. SHE THOUGH THAT THE IMPLANT WAS STILL SHIFTED AND THE INFECTION WAS GETTING WORSE AND ASKED FOR THE LOWER LIP IMPLANT TO BE REMOVED. THE DOCTOR NOTED THAT THERE WAS A SLIGHT OPENING WITH PUS FROM THE LEFT INCISION SITE AND PROCEEDED TO REMOVE THE LOWER LIP IMPLANT. HE RECOMMENDED FOLLOW UP IN ONE WEEK. FIFTEEN DAYS LATER, THE PATIENT RETURNED FOR FOLLOW UP. DOCTOR NOTED THE UPPER LIP IMPLANT LOOKED INTACT AND AESTHETICALLY PLEASING BUT THE PATIENT REQUESTED UPPER LIP REMOVAL. THE SURGEON PROCEEDED TO REMOVE THE IMPLANT. THE PATIENT RETURNED TEN DAYS LATER, FOR SUTURE REMOVAL. THE DEHISCENCE AT THE INCISION SITE REPORTED BY THE DOCTOR AT THE EARLY OF THE MONTH FOLLOW-UP VISIT STRONGLY SUGGESTS THAT THE INFECTION WAS RELATED TO THE IMPLANTATION PROCEDURE AND WAS NOT CAUSED BY INHERENT PROPERTIES OF THE DEVICE ITSELF. ADD'L CATALOG #: VAI5540. ADD'L LOT #: 01063.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH SLIGHT OPENING ON THE LOWER LIP INCISION SITE DURING A FOLLOW UP VISIT. THE WOUND HAD PUS. THE IMPLANT WAS SUBSEQUENTLY REMOVED ON THE SAME DAY (2007). ON THE NEXT FOLLOW UP VISIT FIVE DAYS LATER, THE PATIENT REQUESTED REMOVAL OF THE IMPLANT PLACED IN THE UPPER LIP DESPITE THE SURGEON'S OBSERVATION THAT IT LOOKED AESTHETICALLY PLEASING. THE UPPER LIP IMPLANT WAS REMOVED. EVERA MEDICAL BECAME AWARE OF THE EVENT IN 2008 DURING A ROUTINE CONVERSATION BETWEEN EVERA CUSTOMER SERVICE AND THE SURGEON'S OFFICE PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERAFIL AUGMENTATION IMPLANT STERILE AUGMENTATION IMPLANT FTL EVERA MEDICAL, INC. 01126

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention