BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 9128797 · Received September 27, 2019

    Report

    Report Number
    3007009755-2019-00004
    Event Type
    Injury
    Date Received
    September 27, 2019
    Report Date
    October 3, 2019
    Manufacturer
    SILHOUETTE LIFT INC.
    Product Code
    GAM
    PMA / PMN Number
    K163676
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL COMMENT: TWO SINCLAIR MEDICAL ADVISORS ARE BOTH OF THE OPINION THAT THE SUTURES HAVE BEEN PLACED TOO SUPERFICIALLY. THE PATIENTS UNDERLYING MEDICAL CONDITION OF HERPES COULD BE A CONTRIBUTING FACTOR. ADDITIONAL COMMENT: THE INVESTIGATION IS ONGOING AND ANY ADDITIONAL INFORMATION WILL BE PROVIDED WITHIN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: THE SPECIFIC LOT NUMBER OF THE PRODUCT USED DURING THE TREATMENT WAS NOT PROVIDED, HOWEVER A REVIEW OF ALL SILHOUETTE INSTALIFT LOTS DISTRIBUTED TO THE PRACTITIONER UP TO (B)(6) 2019 FROM SINCLAIR PHARMA US INC. WAS CONDUCTED. ALL LOTS WERE FOUND TO HAVE BEEN MANUFACTURED AND RELEASED IN ACCORDANCE WITH SET SPECIFICATIONS. THERE IS NO EVIDENCE TO SUGGEST A PRODUCT DEFECT.

    Additional Manufacturer Narrative · 1

    MANUFACTURER NARRATIVE THE SPECIFIC LOT NUMBER OF THE PRODUCT USED DURING THE TREATMENT WAS NOT PROVIDED, HOWEVER A REVIEW OF ALL SILHOUETTE INSTALIFT LOTS DISTRIBUTED TO THE PRACTITIONER BETWEEN AUG 2018 AND FEB 2019 WAS CONDUCTED AND ALL LOTS WERE FOUND TO HAVE BEEN MANUFACTURED AND RELEASED IN ACCORDANCE WITH SET SPECIFICATIONS. THERE IS NO EVIDENCE TO SUGGEST A PRODUCT DEFECT. A BATCH TREND REVIEW HIGHLIGHTS ONE SIMILAR EVENT WITH ONE OF THE POTENTIAL BATCHES. (REF: (B)(4) - MDR REF: 3007009755-2019-00003). HOWEVER THIS EVENT DID NOT HAVE THE SAME ROOT CAUSE. CLINICAL COMMENT: A COMPANY MEDICAL ADVISOR IS OF THE OPINION THAT THE PATIENT HAS EXPERIENCED AN INFECTION. CONCLUSION: NO PRODUCT DEFECT HAS BEEN HIGHLIGHTED. THE PROBABLE ROOT CAUSE IS THE PATIENT'S UNDERLYING MEDICAL CONDITION OF (B)(6). POTENTIAL ROOT CAUSES MAY ALSO RELATE TO NON-ASEPTIC TREATMENT CONDITIONS, POOR PATIENT AFTERCARE FOLLOWING TREATMENT OR TOO SUPERFICIAL PLACEMENT OF THE SILHOUETTE INSTALIFT SUTURES. (B)(4).

    Description of Event or Problem · 1

    A PATIENT UNDERWENT TREATMENT WITH SILHOUETTE INSTALIFT IN THE MIDFACE AND JOWLS ON AN UNKNOWN DATE IN (B)(6) 2019. FIVE DAYS POST TREATMENT THE PATIENT EXPERIENCED SWELLING, REDNESS, INFLAMMATION, LUMPS AND BRUISING. ON AN UN-SPECIFIED DATE, THE PATIENT DEVELOPED AN ABSCESS. THE PATIENT WAS PRESCRIBED ANTIBIOTICS, CLINDAMYCIN AND VANCOMYCIN, AND ALSO RECEIVED LASER TREATMENT. DURING TREATMENT OF THE ADVERSE EVENT, THE PRACTITIONER BECAME AWARE THAT THE PATIENT HAS AN UNDERLYING MEDICAL CONDITION OF (B)(6). THE PATIENT WAS SUBSEQUENTLY PRESCRIBED ANTI-VIRAL TREATMENT. THE PATIENT'S SYMPTOMS RESOLVED WITHIN 5 DAYS OF THE ANTI-VIRAL TREATMENT AND THE PATIENT IS CONTINUING TO IMPROVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925046 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SILHOUETTE LIFT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other