BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 8640577 · Received May 24, 2019

    Report

    Report Number
    3007009755-2019-00002
    Event Type
    Injury
    Date Received
    May 24, 2019
    Report Date
    April 24, 2019
    Manufacturer
    SILHOUETTE LIFT INC
    Product Code
    GAM
    PMA / PMN Number
    K163676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMMENT: THE SPECIFIC LOT NUMBER OF THE PRODUCT USED DURING THE TREATMENT WAS NOT PROVIDED; HOWEVER, A REVIEW OF ALL SILHOUETTE INSTALIFT LOTS DISTRIBUTED TO THE PHYSICIAN WAS CONDUCTED AND ALL LOTS WERE FOUND TO HAVE BEEN MANUFACTURED AND RELEASED IN ACCORDANCE WITH SET SPECIFICATIONS. THERE IS CURRENTLY NO EVIDENCE TO SUGGEST A PRODUCT DEFECT. CLINICAL COMMENT: UNABLE TO STATE SPECIFIC CAUSE, ALTHOUGH PROBABLE CAUSES RELATE TO PATIENT MANIPULATION OF THE TREATED AREA AND/OR NON-ASEPTIC ACTIVITY BY THE PATIENT FOLLOWING TREATMENT. CONCLUSION: NO PRODUCT DEFECT HAS BEEN HIGHLIGHTED. THE PROBABLE ROOT CAUSE IS POOR PATIENT AFTERCARE FOLLOWING TREATMENT. (B)(4).

    Description of Event or Problem · 1

    A PATIENT UNDERWENT TREATMENT WITH FIVE SUTURES OF SILHOUETTE INSTALIFT ON (B)(6) 2019. THREE SUTURES WERE PLACED IN THE LEFT CHEEK/MIDFACE AND TWO SUTURES WERE PLACED IN THE RIGHT CHEEK/MIDFACE ON THE (B)(6) 2019, THE PATIENT PRESENTED WITH WHAT APPEARED TO BE TWO ABSCESSES ALONG THE TRACK OF A ONE SINGLE SUTURE ON THE RIGHT HAND SIDE. ADDITIONAL SYMPTOMS REPORTED WERE: INFECTION, INFLAMMATION/SWELLING, VISIBLE SUTURE, PAIN, REDNESS. THE PATIENT RECEIVED THE FOLLOWING TREATMENT: DRAINAGE OF THE ABSCESSES, IRRIGATION OF THE AFFECTED AREA, ORAL ANTIBIOTICS (DOXYCYCLINE). THE PATIENT IS REPORTED TO BE IMPROVING FOLLOWING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434642 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SILHOUETTE LIFT INC

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other