BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 16724795 · Received April 12, 2023

    Report

    Report Number
    3007009755-2023-00001
    Event Type
    Injury
    Date Received
    April 12, 2023
    Date of Event
    September 22, 2022
    Report Date
    March 14, 2023
    Manufacturer
    SINCLAIR PHARMA US INC.
    Product Code
    GAM
    PMA / PMN Number
    K200140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING COMMENT A BATCH INVESTIGATION CONFIRMS THAT LOT 0428-28 WAS MANUFACTURED AND RELEASED WITHIN SPECIFICATION ON (B)(6) 2021. THE COMPLAINTS DATABASE SHOWS THAT ONE OTHER ADVERSE EVENT HAS BEEN RECEIVED FOR THE BATCH. THERE IS NO INDICATION OF ANY BATCH OR PRODUCT RELATED DEFECT. CLINICAL COMMENT MEDICAL AFFAIRS AT THE LOCAL DISTRIBUTOR SPOKE WITH THE TREATING PHYSICIAN ON 14-DEC-2022 AND SUGGESTED AN INCISION AND DRAINAGE OF THE NODULES BE PERFORMED, AS WELL AS A CULTURE OF THE DRAINAGE. THEY RECOMMENDED A BROAD-SPECTRUM ANTIBIOTIC AND DISCUSSED THE PROCESS OF REMOVING THE THREAD FILAMENT FROM THE SUPERFICIAL TISSUE. THE PHYSICIAN PLACED THE PATIENT ON ANTIBIOTICS (CLINDAMYCIN). ON (B)(6) 2023 THE PHYSICIAN CONTACTED MEDICAL AFFAIRS AGAIN, DUE TO WORSENING OF THE SYMPTOMS, IT WAS REPORTED THAT THE ABSCESSES HAD BEEN DRAINED THREE TIMES AND THE PATIENT HAD BEEN ON ANTIBIOTICS (CLINDAMYCIN) FOR FOUR WEEKS. ON (B)(6) 2023 MEDICAL AFFAIRS SPOKE WITH THE TREATING PHYSICIAN AND HE STATED THAT THE INFECTION APPEARS TO BE RESOLVED BUT THE PATIENT HAS HYPERPIGMENTED NODULES IN THE AREAS OF THE PREVIOUS ABSCESSES. THEY ADVISED HIM TO BEGIN INTRALESIONAL KENALOG INJECTIONS (NOT KNOWN IF THIS TREATMENT WAS PERFORMED). A COMPANY MEDICAL ADVISOR REMOTELY ASSESSED THE EVENT. FROM THE INFORMATION PROVIDED, HE IS OF THE OPINION THAT THE SYMPTOMS LOOK MORE LIKE A GRANULOMA THAN AN ABSCESS, AS THERE ARE NO SIGNS OF INFLAMMATION OR ERYTHEMA IN THE OTHER AREAS OF THE FACE. THAT WOULD NOT HAPPEN WITH A BACTERIAL INFECTION, AS HE WOULD EXPECT TO SEE SIGNS OF CELLULITIS IN THE SKIN BETWEEN THE LESIONS. BY THE LOCATION OF THE INFLAMMATORY LESIONS LEFT AND RIGHT SIDES, IT LOOKS CLOSE TO A SUTURE'S ENTRY AND EXIT POINTS BECAUSE: · THE LESIONS ARE CLOSE TO THE EXIT POINTS IN THE LOWER FACE. · A NODULAR FORMATION IN THE RIGHT MID-FACE ALSO LOOKS CLOSE TO THE ENTRY POINT. THEY EXPLAINED THAT THE INFLAMMATORY REACTIONS APPEAR TO BE ASSOCIATED WITH THE ENTRY AND EXIT POINTS WHERE THE SUTURES MIGHT HAVE BEEN PLACED MORE SUPERFICIALLY, OR WERE NOT TRIMMED ENOUGH, AND THE PLGA MATERIAL WAS LEFT IN THE DERMIS. HE CONCLUDED THAT: · THE SUTURES WERE PLACED TOO SUPERFICIALLY AND CLOSE TO THE DERMIS AND THAT IS THE PROBABLE CAUSE OF THE INFLAMMATORY REACTION · IT'S NOT A PRIMARY INFECTION , OTHERWISE THE DRAINAGE AND ANTIBIOTICS SHOULD HAVE RESOLVED IT OTHER COMMENT IT'S BEEN REPORTED THAT THE PATIENT HAS EXPERIENCED A NODULE/INFECTION/ABSCESS. ALTHOUGH, IN THE OPINION OF OUR ADVISOR, THE PATIENT HAS EXPERIENCED A GRANULOMA. THE SILHOUETTE RISK MANAGEMENT FILE (RMF) STATES THAT A PATIENT CAN EXPERIENCE A GRANULOMA DUE TO TOO SUPERFICIAL PLACEMENT OF THE SUTURE. THE RMF STATES THAT AN ABSCESS MAY OCCUR IF THE PHYSICIAN DOES NOT MAINTAIN A STERILE ENVIRONMENT DURING TREATMENT. A PATIENT MAY EXPERIENCE PAIN DUE TO TOO SUPERFICIAL PLACEMENT OF THE SUTURE. THE RMF LISTS THAT A PATIENT MAY EXPERIENCE AN INFECTION DUE TO: · TOO SUPERFICIAL PLACEMENT OF THE SUTURE. · INSUFFICIENT TRIMMING OF THE SUTURE. · THE PHYSICIAN NOT ADEQUATELY STERILISING THE SKIN PRIOR TO TREATMENT. · THE PHYSICIAN CONTAMINATING THE SUTURE WHICH IS SUBSEQUENTLY · INSERTED INTO THE PATIENT. · THE PHYSICIAN NOT MAINTAINING A STERILE ENVIRONMENT DURING TREATMENT. CONSLUSION BASED ON THE INFORMATION AVAILABLE, THE MOST LIKELY ROOT CAUSE HAS BEEN DETERMINED AS USER ERROR; WHERE THE PHYSICIAN MAY HAVE PLACED THE SUTURES TOO SUPERFICIALLY.

    Description of Event or Problem · 0

    ON (B)(6) 2022 A PATIENT RECEIVED TREATMENT WITH SILHOUETTE INSTALIFT. THREE (3) SUTURES WERE PLACED ON EACH SIDE OF THE FACE. ON (B)(6) 2022 THE PATIENT REPORTED THAT A BUMP WAS ALREADY PRESENT FOR A SHORT TIME. THEY WERE ALSO EXPERIENCING TWINGES/PAIN IN THE AREA. ON (B)(6) 2022, THE PATIENT RECEIVED TREATMENT WITH ONE (1) MORE SUTURE TO EACH SIDE OF THE FACE. ON (B)(6) 2022, THE PATIENT REPORTED THAT ANOTHER LUMP APPEARED NEAR THE CHIN, AND THE PREVIOUS LUMPS BECAME INFECTED. THE PHYSICIAN REPORTED THAT ON (B)(6) 2022, THE PATIENT STARTED DEVELOPING NODULES WITHIN THE DERMIS. THESE NODULES WERE INITIALLY SMALL AND WERE OBSERVED FOR A FEW WEEKS, AFTER WHICH POINT THEY WERE ADVANCING IN SIZE. ON (B)(6) 2022 THE PATIENT WAS PRESCRIBED ANTIBIOTICS (CLINDAMYCIN, NO FURTHER INFORMATION). THEY WERE IN PAIN, HAD SLEEPING DIFFICULTIES, VOMITING AND WERE EXPERIENCING HEADACHES. AS OF (B)(6) 2023 THE PATIENT IS FORMING MULTIPLE ABSCESSES, WHICH HAVE REQUIRED TWO FULL COURSE OF ANTIBIOTICS, MULTIPLE DRAINAGES AND MULTIPLE CORTISONE INJECTIONS, WITH MINIMAL IMPROVEMENT. THE PHYSICIAN REPORTED THAT THE PATIENT HAS MULTIPLE NODULES ON EITHER SIDE OF HER FACE, WITH SIGNIFICANT DAMAGE AND DISCOLORATION TO THE SKIN, EXTENDING INTO THE DEEPER DERMIS. THE PATIENT IS ALSO IN EMOTIONAL DISTRESS AND THIS EVENT HAS CAUSED HER PAIN MENTALLY AND PHYSICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2283844 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SINCLAIR PHARMA US INC. 0428-28

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention