BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 11025806 · Received December 17, 2020

    Report

    Report Number
    3007009755-2020-00004
    Event Type
    Injury
    Date Received
    December 17, 2020
    Report Date
    November 27, 2020
    Manufacturer
    SINCLAIR PHARMA US INC.
    Product Code
    GAM
    PMA / PMN Number
    K200140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    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 REPORTING CLINIC BETWEEN 2019 - NOVEMBER 2020 INDICATES THAT THE PATIENT WAS MOST LIKELY TREATED USING LOT 0412-28, EXPIRY DATE 05-2021. THIS LOT WAS MANUFACTURED AND RELEASED IN ACCORDANCE WITH SET SPECIFICATIONS AND THERE IS NO EVIDENCE TO SUGGEST A PRODUCT DEFECT. A LOT TREND REVIEW CONFIRMS THAT SINCLAIR HAVE RECEIVED NO FURTHER EVENTS OF A SIMILAR NATURE IN ASSOCIATION WITH THIS LOT. ADDITIONAL COMMENT; THE INVESTIGATION IS ONGOING AND ANY ADDITIONAL INFORMATION WILL BE PROVIDED WITHIN A FOLLOW-UP REPORT.

    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 0412-28, WHICH APPEARS TO HAVE BEEN USED BY THE CLINIC. NO MANUFACTURING DEFECT WAS NOTED. SINCLAIR FURTHER PERFORMED A STERILITY TEST ON A RETAINED SAMPLE OF THIS LOT AND IT CAN BE CONFIRMED THAT NO BACTERIAL GROWTH WAS PRESENT. OTHER COMMENTS: SINCLAIR ARE NOT AWARE OF ANY FURTHER ADVERSE EVENTS IN ASSOCIATION WITH THE TREATING PRACTITIONER. THE SILHOUETTE INSTALIFT INSTRUCTIONS FOR USE LISTS INFECTION AS A POTENTIAL ADVERSE REACTION POST TREATMENT. CONCLUSION: THERE IS NO EVIDENCE OF ANY PRODUCT DEFECT. DUE TO THE LIMITED INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. POTENTIAL ROOT CAUSES INCLUDE: NON ASEPTIC TREATMENT CONDITIONS, POOR PATIENT AFTERCARE, TOO SUPERFICIAL PLACEMENT OF THE DEVICE(S), UNDERLYING MEDICAL CONDITION . DUE TO THE REPORTED INTERVENTION (DRAINAGE OF ABSCESS), THIS INCIDENT WAS ASSESSED AS BEING REPORTABLE TO THE FDA. ALTHOUGH LIMITED INFORMATION WAS PROVIDED SINCLAIR REPORTED THIS EVENT OUT OF TRANSPARENCY AND COMMITMENT TO VIGILANCE.

    Description of Event or Problem · 0

    DESPITE REQUESTS, NO FURTHER DETAILS ON THE EVENT HAVE BEEN RECEIVED.

    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

    ON AN UNSPECIFIED DATE, A PATIENT UNDERWENT TREATMENT WITH SILHOUETTE INSTALIFT (NO FURTHER DETAILS RECEIVED TO DATE). WITHIN TWO WEEKS OF THE SILHOUETTE INSTALIFT TREATMENT, THE PATIENT EXPERIENCED AN ABSCESS (NO FURTHER DETAILS PROVIDED). THE PATIENT SUBSEQUENTLY UNDERWENT DRAINAGE OF THE ABSCESS AND ON THE (B)(6) 2020 THEY WERE PRESCRIBED BACTRIM ANTIBIOTICS (NO FURTHER DETAILS). AS OF THE (B)(6) 2020, THE PATIENT WAS REPORTED TO HAVE STARTED EXPERIENCING UNSPECIFIED ISSUES ON THE OTHER SIDE. (AWAITING FURTHER DETAILS, BASED ON THE AVAILABLE INFORMATION SINCLAIR ASSUME THAT THE ISSUES PRESENTED ON THE OTHER SIDE OF THE PATIENT'S FACE). THE PATIENT IS REPORTED TO BE USING A NASAL TREATMENT (AWAITING FURTHER DETAILS). SINCLAIR ARE FOLLOWING UP FOR FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493044 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SINCLAIR PHARMA US INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other