BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 6116326 · Received November 21, 2016

    Report

    Report Number
    3007009755-2016-00001
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    October 28, 2016
    Report Date
    October 31, 2016
    Manufacturer
    SILHOUETTE LIFT INC.
    Product Code
    GAM
    PMA / PMN Number
    K142061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A REVIEW IT WAS NOTED THAT THE DATE IN SECTION B4 OF THE INITIAL REPORT WAS INCORRECT. THIS WAS DUE TO A MISUNDERSTANDING OF THE FDA GUIDANCE AND ACTIONS HAVE BEEN TAKEN TO PREVENT RECURRENCE OF THIS ERROR. THIS CORRECTIVE REPORT IS BEING SUBMITTED TO CORRECTLY REFLECT SECTION B4.

    Additional Manufacturer Narrative · 1

    THE DEVICE COULD NOT BE RETURNED TO THE MANUFACTURER DUE TO THIS BEING IMPLANTED IN THE PATIENT. A BATCH RECORD REVIEW WAS CONDUCTED FOR THE BATCH NUMBER PROVIDED, WHICH SHOWED THAT THE PRODUCT WAS RELEASED IN COMPLIANCE WITHIN THE SET SPECIFICATIONS. UPON INVESTIGATION, THE MANUFACTURER CAN CONFIRM THAT THE EVENT REPORTED IN THIS CASE DOES NOT APPEAR TO HAVE A POSSIBLE RELATIONSHIP TO RELEVANT MANUFACTURING OR PRODUCT HISTORY OF THE INSTALIFT PRODUCTS. (B)(4).

    Additional Manufacturer Narrative · 1

    ON THE (B)(6) 2016 IT WAS REPORTED BY THE PRACTITIONER THAT THE PATIENT'S SYMPTOMS HAVE RESOLVED AND DESPITE THE INITIAL REACTION, BOTH PATIENT AND THE PRACTITIONER ARE HAPPY WITH THE TREATMENT RESULTS. SINCLAIR'S MEDICAL ADVISOR INDICATED THAT THERE APPEARS TO BE A DIFFUSE ERYTHEMA, WHICH SUGGESTS AN ALLERGIC REACTION OR POSSIBLY SUPERFICIAL MANIPULATION. IT IS UNLIKELY THAT THE PATIENT WAS ALLERGIC TO THE SUTURE'S POLY-L-LACTIC ACID (PLLA), ACCORDING TO SINCLAIR'S MEDICAL ADVISOR, OTHERWISE THE SYMPTOMS WOULD NOT HAVE BEEN IMPROVED. THE DEVICE LOT NUMBERS HAVE NOT YET BEEN PROVIDED, THEREFORE A COMPREHENSIVE INVESTIGATION COULD NOT BE CARRIED OUT TO DATE. SHOULD THE LOT NUMBERS BE RECEIVED IN THE FUTURE, A FOLLOW UP REPORT WILL BE SUBMITTED. SINCLAIR IS REPORTING THIS ISSUE AS A PRECAUTIONARY MEASURE; IT WAS NOT CONFIRMED THAT THE INTERVENTION PERFORMED WAS TO PRECLUDE PERMANENT DAMAGE OR IMPAIRMENT. (B)(4). IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM PRACTITIONER: THE SKIN WAS PREPARED WITH ISOPROPYL ALCOHOL AND HIBCLENS. SIX THREADS WERE USED. REPORTED SYMPTOMS: MARKED LINER REDNESS, SWELLING IN AREA WHERE SUTURES WERE PLACED. POST PROCEDURE TREATMENT CONSISTED OF AQUAPHOR OINTMENT APPLIED TO ENTRY POINTS. THE PATIENT WAS PRESCRIBED THE FOLLOWING: TOPICAL CORTISONE, ORAL PREDNISONE 60MG X 3 DAYS, 40MG X 3 DAYS, 20MG X 3 DAYS, 10MG X 3 DAYS; CIPRO 500MG BID X 1 DAY. PATIENT FULLY RECOVERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED INSTALIFT TREATMENT, THREE SUTURES EACH SIDE OF THE FACE. REDNESS OCCURRED 24 HOURS AFTER THE PROCEDURE. THE PATIENT DID NOT FEEL ANY PAIN, THE AREA WAS HOT TO TOUCH. THE PHYSICIAN USED LATEX FREE GLOVES DURING THE PROCEDURE, AS THE PATIENT HAS A REPORTED ALLERGY TO LATEX. THE PRACTITIONER THOUGHT THAT IT LOOKED LIKE AN ALLERGIC REACTION. SHE TOLD THE PATIENT TO USE COOL COMPRESSES, TOPICAL CORTISONE CREAM AND TAKE SOME TYLENOL. THE PATIENT IMPROVED SLIGHTLY ON THAT REGIMEN. THE PATIENT WAS THEN PUT ON A ORAL TAPERING DOSE OF PREDNISONE AND 'CIPRO', TO COVER ANY POTENTIAL INFECTION. THE PATIENT LOOKED AND FELT MUCH BETTER THE FOLLOWING DAY. THE 'CIPRO' WAS STOPPED AND PREDNISONE TAPER WAS CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768377 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SILHOUETTE LIFT INC. 0254-28

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other