BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 9390043 · Received November 28, 2019

    Report

    Report Number
    3007009755-2019-00010
    Event Type
    Injury
    Date Received
    November 28, 2019
    Report Date
    January 23, 2020
    Manufacturer
    SILHOUETTE LIFT INC.
    Product Code
    GAM
    PMA / PMN Number
    K163676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER COMMENT: FOLLOWING A STERILITY TEST ON A RETAINED SAMPLE OF LOT 0398-28, IT WAS CONFIRMED THAT NO BACTERIAL GROWTH WAS PRESENT. FOLLOWING A THOROUGH REVIEW OF BATCH RECORDS, NO MANUFACTURING DEVIATIONS WERE IDENTIFIED FOR LOT 0396-28 AND PRODUCTION WAS COMPLETED ACCORDING TO THE CORRECT MANUFACTURING SPECIFICATION. THERE HAVE BEEN NO OTHER ADVERSE EVENTS OF A SIMILAR NATURE REPORTED FOR LOT 0396-28. CLINICAL COMMENT: POTENTIAL ROOT CAUSES MAY RELATE TO NON-ASEPTIC TREATMENT CONDITIONS, AN UNDERLYING MEDICAL CONDITION OR TOO SUPERFICIAL PLACEMENT OF THE SUTURES. ADDITIONAL INFORMATION: A REVIEW OF ALL ADVERSE EVENTS REPORTED TO SILHOUETTE LIFT INC. CONFIRM NO OTHER REPORTED ADVERSE EVENTS OF A SIMILAR NATURE IN ASSOCIATION WITH THE TREATING PRACTITIONER. CONCLUSION: POTENTIAL ROOT CAUSES MAY RELATE TO: · NON-ASEPTIC TREATMENT CONDITIONS; · POOR PATIENT AFTERCARE; · TOO SUPERFICIAL PLACEMENT OF THE SUTURES; · AN UNDERLYING MEDICAL CONDITION. THERE IS NO EVIDENCE TO SUGGEST A PRODUCT DEFECT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER COMMENT A REVIEW OF THE BATCH RECORDS CONFIRMED THAT THE INVOLVED LOTS (0398-28 AND 0396-28) WERE MANUFACTURED AND RELEASED IN ACCORDANCE WITH SET SPECIFICATIONS. THERE IS NO EVIDENCE TO SUGGEST A PRODUCT DEFECT. A BATCH TREND REVIEW SHOWS ONE OTHER EVENT IN ASSOCIATION WITH LOT 0398-28, SINCLAIR REF: (B)(4), FDA REF: 3007009755-2019-00005. THERE HAVE BEEN NO OTHER EVENTS REPORTED TO SINCLAIR IN ASSOCIATION WITH LOT 0396-28. RETAINED SAMPLE TESTING ON LOT 0398-28 HAS BEEN REQUESTED AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW UP REPORT. CLINICAL COMMENT: THE TREATING PRACTITIONER IS OF THE OPINION THAT THE PATIENT HAS NOT FOLLOWED THE RECOMMENDED POST TREATMENT AFTERCARE. CONCLUSION: THE INVESTIGATION IS ONGOING AND THE INVESTIGATION CONCLUSION WILL BE PROVIDED WITHIN A FOLLOW-UP REPORT.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT TREATMENT WITH SILHOUETTE INSTALIFT ON (B)(6) 2019. FOUR SUTURES WERE INSERTED IN THE RIGHT SIDE OF THE FACE AND FIVE SUTURES WERE INSERTED IN THE LEFT SIDE. THE PATIENT DID NOT RETURN FOR THEIR FOLLOW UP APPOINTMENT ONE WEEK AFTER TREATMENT. THREE WEEKS POST TREATMENT; THE PATIENT CONTACTED THE TREATING PRACTITIONER AND REPORTING EXPERIENCING ISSUES (NOT SPECIFIED). THE PATIENT WAS ASKED TO RETURN FOR A REVIEW: THEY WERE PRESCRIBED ORAL ANTIBIOTICS (NOT SPECIFIED) WHICH THE ISSUE DID NOT RESPOND TO. THE PRACTITIONER THEN PRESCRIBED IV ANTIBIOTICS (DATE NOT SPECIFIED). THE PATIENT UNDERWENT A CAT SCAN OF THE AFFECTED AREA (DATE NOT SPECIFIED AND NO RESULTS PROVIDED TO (B)(6)). AN INFECTIOUS DISEASE SPECIALIST REVIEWED THE PATIENT (NO RESULTS PROVIDED TO (B)(6)). A PLASTIC SURGEON REMOVED AT LEAST ONE SUTURE ON ONE SIDE OF THE FACE (NO FURTHER DETAILS PROVIDED) SUBSEQUENTLY FOLLOWED BY DRAINAGE OF THE AREA. THE PATIENT HAS NOT RETURNED TO THE CLINIC.

    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. SINCLAIR PHARMACEUTICALS LTD. (REGISTRATION NUMBER (B)(4)) IS SUBMITTING THIS REPORT ON BEHALF OF SILHOUETTE LIFT INC.(REGISTRATION NUMBER (B)(4)).

    Description of Event or Problem · 1

    ON AN UNSPECIFIED DATE, A PATIENT UNDERWENT TREATMENT WITH SILHOUETTE INSTALIFT. THE PATIENT LATER EXPERIENCED AN INFECTION AND RECEIVED ANTIBIOTIC TREATMENT, INCLUDING IV ANTIBIOTICS. THE INFECTION WAS REPORTED TO HAVE PERSISTED AND THE SUTURES WERE SUBSEQUENTLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184779 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SILHOUETTE LIFT INC. 0396-28, 0398-28

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other