BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 8757270 · Received July 3, 2019

    Report

    Report Number
    3007009755-2019-00003
    Event Type
    Injury
    Date Received
    July 3, 2019
    Report Date
    June 7, 2019
    Manufacturer
    SILHOUETTE LIFT INC.
    Product Code
    GAM
    PMA / PMN Number
    K163676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMMENT: FOLLOWING A REVIEW OF THE BATCH RECORDS FOR THE LOT NUMBER CONCERNED IT WAS CONFIRMED THAT THE DEVICE WAS MANUFACTURED AND RELEASED PER THE SET SPECIFICATIONS WITH NO RELEVANT MANUFACTURING OR PRODUCT HISTORY. THERE IS NO EVIDENCE TO SUGGEST A PRODUCT DEFECT. CLINICAL COMMENT: A POSSIBLE CAUSE OF THE EVENT MAY RELATE TO AN ALLERGIC REACTION. THE EVENT DOES NOT APPEAR TO BE AN INFECTION. THE NODULES PRESENT APPEAR TO BE CONES, WHICH MAY BE AS A RESULT OF TOO SUPERFICIAL PLACEMENT OF THE SUTURES. CONCLUSION: NO PRODUCT DEFECT HAS BEEN HIGHLIGHTED. THE PROBABLE ROOT CAUSE IS AN ALLERGIC REACTION OR TOO SUPERFICIAL PLACEMENT OF THE PRODUCT. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT TREATMENT WITH 4 SUTURES OF SILHOUETTE INSTALIFT ON (B)(6) 2018. ONE SUTURE WAS PLACED IN THE PATIENT'S MIDFACE AND ONE IN THE JAWLINE ON EACH SIDE OF THE FACE. APPROXIMATELY 1 MONTH POST TREATMENT, THE PATIENT PRESENTED WITH ABSCESSES IN THE LOWER FACE. ADDITIONAL ABSCESSES ALONG THE TRACK OF THE SUTURES WERE PRESENT AT FOLLOW-UP REVIEWS. THE PATIENT HAS RECEIVED THE FOLLOWING TREATMENT FOR THE ISSUE: INTRALESIONAL INJECTIONS OF CORTISONE, THE TREATING PHYSICIAN ATTEMPTED TO REMOVE THE CONES, PICOSECOND FOCUS LENS LASER TREATMENT. THE PATIENT IS REPORTED TO BE IMPROVING FOLLOWING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551761 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SILHOUETTE LIFT INC. 0369-28

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention