BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 11124595 · Received January 6, 2021

    Report

    Report Number
    3007009755-2021-00001
    Event Type
    Injury
    Date Received
    January 6, 2021
    Report Date
    January 8, 2021
    Manufacturer
    SINCLAIR PHARMA US INC
    Product Code
    GAM
    PMA / PMN Number
    K200140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER COMMENT: THE LOT NUMBER OF THE PRODUCT USED DURING TREATMENT WAS NOT PROVIDED. SINCLAIR HAS NEVERTHELESS PERFORMED A BATCH REVIEW ON LOT NUMBER 0405-28, WHICH APPEARS TO HAVE BEEN USED BY THE CLINIC. NO MANUFACTURING DEFECT WAS NOTED AND THE BATCH WAS RELEASED IN COMPLIANCE WITH ALL RELEVANT SPECIFICATIONS. SINCLAIR FURTHER PERFORMED A STERILITY TEST ON A RETAINED SAMPLE OF THIS LOT, AND IT CAN BE CONFIRMED THAT NO BACTERIAL GROWTH WAS PRESENT. A BATCH TREND REVIEW SHOWS THAT SINCLAIR ARE AWARE OF THREE ADVERSE EVENTS IN ASSOCIATION WITH THIS LOT: ONE EVENT RELATING TO PAIN, ONE EVENT RELATING TO AN EXTRUDING CONE (MOST LIKELY DUE TO INCORRECT PHYSICIAN TECHNIQUE) AND AN EVENT OF INFECTION THAT RESOLVED, THOUGH WAS MOST LIKELY ASSOCIATED WITH INCORRECT PHYSICIAN TECHNIQUE. THERE IS NO BATCH-RELATED DEFECT OR TREND APPARENT BASED ON THESE PREVIOUS EVENTS. INFECTION IS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT CAN OCCUR POST TREATMENT. CONCLUSION: USING LOCAL MEDICAL EXPERTISE FROM THE DISTRIBUTOR, THE MOST PROBABLE ROOT CAUSE APPEARS TO BE INADEQUATE DISINFECTION PRIOR TO INSERTION OF THE DEVICES. BASED ON THE INITIAL INFORMATION RECEIVED, SINCLAIR REPORTED THIS EVENT OUT OF TRANSPARENCY AND COMMITMENT TO VIGILANCE. HOWEVER, BASED ON THE LOCAL DISTRIBUTOR MEDICAL EXPERTISE THE EVENT HAS SINCE BEEN REASSESSED AS A MINOR ADVERSE EVENT WHICH WOULD NOT MEET REPORTING CRITERIA.

    Additional Manufacturer Narrative · 0

    MANUFACTURER COMMENT: THE SPECIFIC LOT NUMBER OF THE PRODUCT USED DURING THE TREATMENT WAS NOT PROVIDED. HOWEVER, THE DISTRIBUTION RECORDS SHOWING THE SILHOUETTE INSTALIFT LOTS SUPPLIED TO THE CLINIC BETWEEN 2018-2020 INDICATES THAT THE PATIENT WAS MOST LIKELY TREATED USING LOT 0405-28, EXP 2021-01. THIS LOT WAS MANUFACTURED AND RELEASED IN ACCORDANCE WITH SET SPECIFICATIONS AND THERE IS NO EVIDENCE TO SUGGEST A PRODUCT DEFECT. ADDITIONAL COMMENT: THE INVESTIGATION IS ONGOING AND ANY ADDITIONAL INFORMATION WILL BE PROVIDED WITHIN A FOLLOW-UP REPORT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT; THE PATIENT UNDERWENT TREATMENT WITH FOUR SUTURES INSERTED INTO EACH SIDE OF THE FACE (PREVIOUSLY REPORTED AS THREE SUTURES INSERTED INTO EACH SIDE OF THE FACE). TWO WEEKS POST TREATMENT, THE PATIENT REPORTED EXPERIENCING IRRITATION, REDNESS, SWELLING AND PAIN TO THE RIGHT CHEEK. ON (B)(6) 2020 (PREVIOUSLY REPORTED AS (B)(6) 2020), THE PATIENT WAS REVIEWED BY THE TREATING PHYSICIAN WHO NOTED REDNESS, INFLAMMATION AND PAIN TO THE RIGHT MID-CHEEK, WHICH PRESENTED AS A RED LINEAR LESION. THE PHYSICIAN CLEANED THE AREA WITH AN ANTI-MICROBIAL AGENT (FURTHER DETAILS NOT PROVIDED) AND THE PATIENT WAS PRESCRIBED CIPROFLOXACIN ANTIBIOTICS. ON THE (B)(6) 2020, FOLLOWING THE REVIEW WITH THE TREATING PHYSICIAN, THE PATIENT WAS NOT PRESCRIBED ANY FURTHER TREATMENT ON THIS DATE. ON (B)(6) 2020 (PREVIOUSLY REPORTED AS (B)(6) 2020), THE PHYSICIAN REPORTED THAT THE EVENT WAS ONGOING AND THAT THE PATIENT REQUIRED IPL (INTENSE PULSED LIGHT LASER) TREATMENT TO TREAT DISCOLOURATION. (NO FURTHER DETAILS PROVIDED). ON (B)(6) 2020, THE TREATING PHYSICIAN SPOKE WITH MEDICAL AFFAIRS OF THE LOCAL DISTRIBUTOR AND THEY DISCUSSED THE EVENT. THE PHYSICIAN ADVISED THE DISTRIBUTOR THAT THE PATIENT WAS REPORTED TO BE IMPROVING.

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMMENT: ADDITIONAL INFORMATION, INCLUDING THE LOT NUMBER OF THE INVOLVED PRODUCT, HAS BEEN REQUESTED. SINCLAIR ARE NOT AWARE OF ANY LOT RELATED TRENDS IN ASSOCIATION WITH INFECTION. CLINICAL COMMENT: THE INVESTIGATION IS ONGOING AND THE CLINICAL CONCLUSION WILL BE PROVIDED WITHIN A FOLLOW-UP REPORT. CONCLUSION: THE INVESTIGATION IS ONGOING AND THE INVESTIGATION CONCLUSION WILL BE PROVIDED WITHIN A FOLLOW-UP REPORT. (B)(4).

    Description of Event or Problem · 1

    A PATIENT UNDERWENT TREATMENT ON (B)(6) 2020 WITH SIX (6), 8-CONE SILHOUETTE INSTALIFT SUTURES IN THE FACE. ON (B)(6) 2020, THE PATIENT PRESENTED TO THEIR PHYSICIAN WITH EVIDENCE OF AN INFECTION ON THE RIGHT SIDE OF THE FACE (NO FURTHER DETAILS PROVIDED). THE PATIENT WAS PRESCRIBED CIPROFLOXACIN ANTIBIOTICS (500MG TWICE DAILY FOR 14 DAYS). THE PATIENT WAS LATER REVIEWED ON (B)(6) 2020, WITH NO EVIDENCE OF AN ONGOING INFECTION. ON (B)(6) 2020, THE PATIENT PRESENTED WITH AN AREA OF REDNESS (FURTHER DETAILS NOT PROVIDED). THE PATIENT WAS REFERRED FOR URGENT CARE (NOT SPECIFIED) AND RECEIVED DOXYCYCLINE ANTIBIOTICS. ON (B)(6) 2020, THE PHYSICIAN REPORTED THAT THE EVENT WAS ONGOING AND THAT THE PATIENT REQUIRED INTENSE PULSED LIGHT (IPL) LASER TREATMENT TO TREAT DISCOLOURATION. SINCLAIR ARE FOLLOWING UP FOR FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23017 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SINCLAIR PHARMA US INC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other