BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 7182247 · Received January 11, 2018

    Report

    Report Number
    3007009755-2017-00004
    Event Type
    Injury
    Date Received
    January 11, 2018
    Date of Event
    January 1, 2017
    Report Date
    December 15, 2017
    Manufacturer
    SILHOUETTE LIFT INC.
    Product Code
    GAM
    PMA / PMN Number
    K163676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE DETAILS HAVE NOT BEEN PROVIDED. A BATCH REVIEW WILL BE CARRIED OUT ONCE THE PRODUCT LOT NUMBER BECOMES AVAILABLE. THE INSTALIFT IFU PROVIDES INSTRUCTIONS ON IMPLANT PROCEDURES AND TRIMMING OF EXCESS ENDS OF THE SUTURES DURING THE PROCESS. THE IFU ALSO LISTS PRECAUTIONS THAT A SUPERFICIAL PLACEMENT OF THE DEVICE COULD LEAD TO VISUAL OR PALPABLE IDENTIFICATION OR EXTRUSION (OF THE THREAD). THIS INVESTIGATION IS ONGOING AND THE RESULTS WILL BE PROVIDED IN A FOLLOW UP REPORT.

    Additional Manufacturer Narrative · 1

    DESPITE ATTEMPTS, THE PRACTITIONER DID NOT RESPOND TO FOLLOW UP REQUESTS. NO FURTHER INFORMATION INTO THE EVENT, PATIENT UPDATE OR THE PRODUCT DETAILS WERE AVAILABLE. SINCLAIR'S MEDICAL ADVISOR HAS REMOTELY ASSESSED THE INFORMATION PROVIDED AND IS OF THE OPINION THAT THE EVENT OCCURRED DUE TO USER ERROR IN CUTTING OFF THE EXTREMITY WHEN PLACING THE PRODUCT. THE ADVISOR IS ALSO OF THE OPINION THAT INJECTING TRIAMCINOLONE WAS NOT RECOMMENDED AS THE PRODUCT IS VERY AGGRESSIVE TO THE SKIN AND CAN INDUCE FAT NECROSIS. SINCLAIR HAVE NOT ASSESSED THIS CASE AS CAUSING OR HAVING THE POTENTIAL TO CAUSE A SERIOUS DETERIORATION IN HEALTH OR PERMANENT DAMAGE TO THE PATIENT. THIS CASE WILL NOW BE CLOSED.

    Description of Event or Problem · 1

    THIS REPORT IS RELATES TO (B)(4). IT WAS REPORTED THAT THE PATIENT DEVELOPED A FIRM, RED AND INDURATED BUMP ON THE RIGHT SIDE OF HER FACE, A MONTH FOLLOWING TREATMENT WITH INSTALIFT. THE PATIENT IS AN ER DOCTOR AND CUT OFF 2 KNOTS THAT HAD PROTRUDED THROUGH THE SKIN. KENALOG 2.5 WAS INJECTED ON (B)(6) 2017 AND KENALOG 5 WAS INJECTED ON (B)(6) 2017. THE PATIENT IS EXPERIENCING A SMALL INDURATED BUMP AND CAN FEEL THE THREAD PROTRUDING ON THE LEFT SIDE AS WELL.

    Description of Event or Problem · 1

    THIS REPORT IS RELATES TO SINCLAIR REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26482 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SILHOUETTE LIFT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention