BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 7450978 · Received April 23, 2018

    Report

    Report Number
    3007009755-2018-00002
    Event Type
    Injury
    Date Received
    April 23, 2018
    Date of Event
    February 21, 2018
    Report Date
    March 24, 2018
    Manufacturer
    SILHOUETTE LIFT INC.
    Product Code
    GAM
    PMA / PMN Number
    K163676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A REVIEW IT WAS NOTED THAT THE DATE IN 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.

    Additional Manufacturer Narrative · 1

    THE COMPANY MEDICAL ADVISOR PROVIDED A REMOTE MEDICAL ASSESSMENT BASED ON THE AVAILABLE INFORMATION. HE WAS OF THE OPINION THAT THE PATIENT HAD EXPERIENCED A LOW GRADE LOCAL INFECTION RATHER THAN A BIOFILM. HE FURTHER COMMENTED THAT THE MAIN CHARACTERISTIC OF A BIOFILM IS THAT IT DOES NOT RESPOND TO ANTIBIOTICS AS THE BACTERIA ENCASPSULATE THEMSELVES IN A PROTEIN MEMBRANE WHICH PROTECTS IT FROM ANYTHING, INCLUDING DISINFECTANTS. THE TREATING PHYSICIAN ADVISED THAT THE LOT NUMBER OF THE PRODUCT WAS UNAVAILABLE AS THE PACKAGING WAS DISCARDED AFTER USE. A LIST OF BATCHES THAT WERE PROVIDED TO THE TREATING PHYSICIAN DURING FEBRUARY 2017 - FEBRUARY 2018 WERE CHECKED. UPON REVIEWING THE LIST OF BATCHES, THERE DOES NOT APPEAR TO BE A TREND IN THE BATCH NUMBER AND THE ADVERSE EVENT REPORTED. A REVIEW OF THE BATCH RECORDS FOR THE BATCHES WERE MANUFACTURED AND RELEASED IN COMPLIANCE WITHIN SET SPECIFICATIONS AND THERE WERE NO PRODUCT DEFECTS IDENTIFIED. IT WAS NOTED THAT THERE HAVE BEEN NO OTHER INCIDENTS REPORTED BY THIS PHYSICIAN. A ROOT CAUSE FOR THE EXPERIENCED ISSUES COULD NOT BE CONFIRMED, HOWEVER THIS MAY RELATE TO A POTENTIAL TREATMENT ERROR OR POOR PATIENT HYGIENE FOLLOWING TREATMENT. THE COMPANY MEDICAL ADVISOR WAS OF THE OPINION THAT THE INITIAL EVENTS OF OEDEMA AND LUMPS COULD BE DUE TO THE PLACEMENT OF THE THREADS. IT WAS NOT CONFIRMED IF THE PATIENT WAS EXPERIENCING A LOW GRADE INFECTION OR A BIOFILM. THE EVENT OF AN INFECTION OR BIOFILM MAY RELATE TO A LACK OF ASEPTIC TREATMENT CONDITIONS OR INSUFFICIENT PATIENT AFTERCARE. THE PATIENT DOES NOT HAVE ANY PRE-EXISTING MEDICAL CONDITIONS OR RELEVANT MEDICAL HISTORY AND SHE HAS NOT RECEIVED TREATMENT PREVIOUSLY.

    Description of Event or Problem · 1

    IT WAS REPORTED ON THE (B)(4) 2018 THAT A PATIENT HAD EXPERIENCED ISSUES FOLLOWING THEIR TREATMENT WITH SILHOUETTE INSTALIFT ON THE (B)(6) 2018. A PHOTOGRAPH WAS PROVIDED WHICH APPEARED TO SHOW SMALL LUMPS. THE PHYSICIAN ADVISED THAT THEY WERE SOFT AND OEDEMATOUS, WITH NO THREAD OR CONE PALPABLE OR VISIBLE WITH A DERMASCOPE. THE PHYSICIAN STATED THAT THEY HAD INJECTED THE PATIENT WITH KENALOG. FOLLOWING THE PROVISION OF THIS INFORMATION, THE TREATING PHYSICIAN ADVISED ON THE (B)(6) 2018 THAT THE REPORTED EVENT WAS NOT SERIOUS NOR PERMANENT. THE PATIENT'S TREATMENT DETAILS WERE LATER PROVIDED BY THE TREATING PHYSICIAN. IT WAS CONFIRMED THAT THE PATIENT HAD RECEIVED TREATMENT WITH A TOTAL OF FOUR THREADS, WITH TWO THREADS TO EACH SIDE OF THE FACE .THE ENTRY POINTS OF THE THREADS WERE IN THE MID CHEEKS AND THE EXIT POINTS OF THE THREADS WERE IN THE CHIN AND THE NASOLABIAL FOLD. AN IMAGE WAS PROVIDED DEMONSTRATING THE THREAD PATTERN USED. IT WAS CONFIRMED THAT THE PATIENT FIRST APPEARED TO EXPERIENCE ISSUES ON THE (B)(6) 2018. THE PHYSICIAN ADVISED THAT NO OTHER PRODUCTS WERE USED AT THE TIME OR BEFORE THE EVENT AND THAT THE PATIENT HAS NO PRE-EXISTING MEDICAL CONDITIONS OR RELEVANT MEDICAL HISTORY. NO TESTS HAD BEEN PERFORMED AT THIS STAGE. ON THE (B)(6) 2018, THE TREATING PHYSICIAN ADVISED THAT THE PATIENT WAS MUCH BETTER AND THAT THE ISSUE WAS SLOWLY RESOLVING. THE PATIENT WOULD APPEAR TO HAVE BEEN EXAMINED AGAIN WITH A DERMATOSCOPE WHICH DID NOT REVEAL ANY PROTRUDING SUTURE. UPON PALPATION OF THE CHEEKS THIS ALSO FAILED TO REVEAL A CONE IN THE VICINITY OF THE LUMP. ON THE (B)(6) 2018, THE PHYSICIAN ADVISED THAT THE PATIENT EXPERIENCED A FLARE UP APPROXIMATELY IN FOUR SEPARATE SITES, TWO ON EACH SIDE. THE PHYSICIAN FELT THAT THIS RELATED TO A BIOFILM INFECTION AND PRESCRIBED THE PATIENT ANTIBIOTICS (MINOCYCLINE 100 MG PER DAY). HE ADVISED ON THIS DATE THAT IT HAD BEEN TWO WEEKS AFTER THE FLARE UP AND THAT THE PATIENT WAS STILL TAKING THE TREATMENT. THE SYMPTOMS WERE REPORTED TO HAVE RESOLVED AND THE PATIENT HAD RETAINED A GOOD CLINICAL RESULT COSMETICALLY. THE TREATING PHYSICIAN ADVISED THAT THE BATCH NUMBER WAS UNAVAILABLE AS THEY DISCARDED THE PACKAGING AFTER USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294474 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SILHOUETTE LIFT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other