BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 7153936 · Received December 29, 2017

    Report

    Report Number
    3007009755-2017-00003
    Event Type
    Injury
    Date Received
    December 29, 2017
    Date of Event
    November 13, 2017
    Report Date
    December 3, 2017
    Manufacturer
    SILHOUETTE LIFT INC.
    Product Code
    GAM
    PMA / PMN Number
    K163676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A REVIEW IT WAS NOTED THAT THE DATE 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.

    Additional Manufacturer Narrative · 1

    ON THE (B)(4) 2017, SILHOUETTE LIFT INC WERE INFORMED THAT THE PHYSICIAN HAD NOTED NO SIGNS OF INFECTION AND THAT THEY WERE GOING TO MONITOR THE PATIENT CLOSELY. THE PHYSICIAN REPORTED TO SILHOUETTE LIFT INC ON THE (B)(6) 2017 THAT THE PATIENT TOOK FORCEPS, PULLED ON THE EXTRUDED THREAD AND CUT IT AT THE SKIN LEVEL. THE PATIENT IS NOW FINE. UPON ASSESSING THE AVAILABLE INFORMATION, THE COMPANY MEDICAL ADVISOR IS OF THE OPINION THAT NOT CUTTING THE THREAD MAY HAVE RESULTED IN A MORE OBVIOUS EXTRUSION WHICH COULD HAVE POTENTIALLY LED TO A LOCAL INFECTION. HE IS OF THE OPINION THAT CUTTING THE EXTREMITY WAS THE CORRECT THING TO DO, WITH LOCAL DISINFECTION. HE FURTHER COMMENTED THAT THE REPORTED ISSUE HAD NOT RESULTED IN A SERIOUS DETERIORATION IN HEALTH TO THE PATIENT OR A LIFE THREATENING SITUATION. HOWEVER HAD THE INTERVENTION NOT HAVE BEEN CARRIED OUT, THE REPORTED ISSUE COULD HAVE RESULTED IN INFECTION OR A FOREIGN BODY REACTION AND MAY HAVE LED TO A SERIOUS DETERIORATION IN HEALTH TO THE PATIENT. IT WOULD APPEAR THAT THE REPORTED EVENT RELATES TO THE PHYSICIAN NOT TRIMMING THE DISTAL END OF THE THREAD CLOSE ENOUGH TO THE SKIN. THE SILHOUETTE INSTALIFT INSTRUCTIONS FOR USE STATES TO TRIM THE EXCESS ENDS OF THE SUTURES AND THAT IT IS DESIRABLE TO BURY THE END OF THE SUTURES EITHER UNDER ADJACENT, MOBILIZED SOFT ISSUE OR FASCIA TO AVOID POSSIBLE ERROSION OF THE DEVICE THROUGH THE SKIN. THE PATIENT HAS NO PRE-EXISTING CONDITIONS OR RELEVANT MEDICAL HISTORY. A BATCH RECORD REVIEW INTO THE REPORTED LOT NUMBER CONFIRMS THAT THE PRODUCT WAS MANUFACTURED AND RELEASED WITHIN THE SET SPECIFICATIONS. THERE IS NO KNOWN LINK OF MANUFACTURING DEFECT TO THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS A SINGLE-USE DEVICE THAT WAS NOT REPROCESSED AND REUSED ON A PATIENT. THE REPROCESSOR CONTACT DETAILS ORIGINALLY PROVIDED IN SECTION ARE NOT APPLICABLE AND WERE INCLUDED IN ERROR. THE DETAILS ORIGINALLY PROVIDED IN SECTION ARE THE CONTACT DETAILS OF THE INITIAL REPORTER.

    Description of Event or Problem · 1

    SILHOUETTE LIFT INC WERE INFORMED ON THE (B)(6) 2017, THAT A PATIENT EXPERIENCED SOME ISSUES FOLLOWING TREATMENT WITH SILHOUETTE INSTALIFT. THE PATIENT RECEIVED TREATMENT WITH SILHOUETTE INSTALIFT ON THE 2(B)(6) 2017 AND BEGAN TO EXPERIENCE ISSUES ON THE (B)(6) 2017. THE PATIENT EXPERIENCED REDNESS AND SWELLING ON THE RIGHT SIDE OF THE FACE IN THE TREATED AREA, SPECIFICALLY IN THE RIGHT JAW BY HER LIP, AND THE THREAD TIP IS EXPOSED THROUGH THE EPIDERMIS TISSUES. A PHOTOGRAPH HAS BEEN PROVIDED CONFIRMING THE REPORTED ISSUE. NO OTHER PRODUCTS WERE IN USE AT THE TIME OR PRIOR TO THE TREATMENT . AT THIS STAGE ((B)(6) 2017), NO MEDICAL INTERVENTION HAS BEEN CARRIED TO TREAT THE REPORTED ISSUE. THE TREATING PHYSICIAN REPORTED THAT THE EVENT HAS NOT RESULTED IN ANY POTENTIAL OR PERMANENT DAMAGE OR IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933733 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SILHOUETTE LIFT INC. 0307-28

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention