BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 25181059 · Received May 15, 2026

    Report

    Report Number
    3007009755-2026-00002
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 15, 2026
    Manufacturer
    SINCLAIR PHARMA US INC
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT TREATED WITH SILHOUETTE INSTALIFT (TREATMENT DATE UNKNOWN) DEVELOPED A NODULE AROUND ONE THREAD, REQUIRING THE TREATING HCP TO INJECT IT WITH 5-FU/KENALOG TO RESOLVE. NO IMAGES RECEIVED. IT HAS BEEN CONFIRMED BY THE LEGAL MANUFACTURER OF THE PRODUCT THAT THERE WERE NO RELEVANT PRODUCT OR MANUFACTURING HISTORY ASSOCIATED WITH THE CONCERNED BATCH SILHOUETTE INSTALIFT (LOT: 0488-28) REGARDING CASES OF NODULES. IN ADDITION, THERE WERE NO MANUFACTURING NON- CONFORMITIES HIGHLIGHTED DURING THE MANUFACTURE OF LOT: 0488-28. LISTED BELOW ARE THE DETAILS: LOT 0488-28: MANUFACTURE DATE: SEPTEMBER 2025, BATCH/ LOT SIZE: (B)(4) BOXES / (B)(4) SUTURES, RELEASE DATE: 29-SEP-2025, EXPIRY DATE: MARCH 2027. TREATING PHYSICIAN PROVIDER VERIFIED THAT THEY DO NOT WANT CLINICAL GUIDANCE RELATED TO THE PATIENT NOTED IN THE REPORT AS THEY HAVE TREATED THE PATIENT AND DOES NOT HAVE ANY FURTHER CONCERNS RELATED TO THE PATIENT IN QUESTION. TREATING HCP WOULD LIKE FURTHER GUIDANCE TO DISCUSS HOW TO PREVENT FUTURE OCCURENCES OF THE EVENT. DIRECTOR OF CLINICAL EDUCATION AT SINCLAIR'S DISTRIBUTOR IN THE REGION TO CONDUCT A CALL WITH THE PROVIDER ON 29-MAY-2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27483 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SINCLAIR PHARMA US INC SMS 28 0488-28

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other