BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 22519319 · Received July 16, 2025

    Report

    Report Number
    3007009755-2025-00001
    Event Type
    Injury
    Date Received
    July 16, 2025
    Date of Event
    May 21, 2025
    Report Date
    September 15, 2025
    Manufacturer
    SINCLAIR PHARMA US INC.
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE ADVERSE EVENT HAS RESOLVED.

    Additional Manufacturer Narrative · 0

    THE ADVERSE EVENT HAS RESOLVED. THERE WERE NO MANUFACTURING NON-CONFORMITIES HIGHLIGHTED DURING THE MANUFACTURE OF SILHOUETTE INSTALIFT LOT 0480-28.

    Description of Event or Problem · 0

    A FEMALE PATIENT WAS TREATED AT A SILHOUETTE INSTALIFT TRAINING WORKSHOP ON (B)(6) WITH 2 SUTURES TO EITHER SIDE OF THE FACE. PATIENT DEVELOPED AN ABSCESS TWO DAYS LATER IN MID FACE. PATIENT WAS TREATED WITH ANTIBIOTICS, BACTRUM. 20CC WAS ASPIRATED FROM THE ABSCESS FOR CULTURE. ASPIRATION CULTURE SHOWED NIL GROWTH. ABSCESS SUBSIDED ABOUT 10-12 DAYS LATER.

    Description of Event or Problem · 0

    A FEMALE PATIENT WAS TREATED AT A SILHOUETTE INSTALIFT TRAINING WORKSHOP ON MAY 19TH WITH 2 SUTURES TO EITHER SIDE OF THE FACE. PATIENT DEVELOPED AN ABSCESS TWO DAYS LATER IN MID FACE. PATIENT WAS TREATED WITH ANTIBIOTICS, BACTRUM. 20CC WAS ASPIRATED FROM THE ABSCESS FOR CULTURE. ASPIRATION CULTURE SHOWED NIL GROWTH. ABSCESS SUBSIDED ABOUT 10-12 DAYS LATER. CLINICAL NOTES RECEIVED FROM MEDICAL ADVISOR WHO CONTACTED THE TREATING PHYSICIAN DIRECTLY ARE AS FOLLOWS : "TWO DAYS POST INSERTION OF 8(8) CONE IL THREADS, INTO THE BL MIDFACE THE PATIENT PRESENTED WITH A 2 X 2 CM ABSCESS, MILD INDURATION AND PAIN. APPROXIMATELY 20 CC OF SEROSANGUINOUS FLUID WAS ASPIRATED AND RETURNED NEGATIVE FOR PATHOGENS FROM PATHOLOGY. THE PROVIDER INITIATED A 7-DAY COURSE OF BACTRIM, AFTER WHICH THE ABSCESS, INDURATION AND PAIN FULLY RESOLVED NO FURTHER COMPLICATIONS WERE REPORTED." NO FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152255 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SINCLAIR PHARMA US INC. SMS 28 0480-28

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention