BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 7420530 · Received April 11, 2018

    Report

    Report Number
    3007009755-2018-00003
    Event Type
    Injury
    Date Received
    April 11, 2018
    Report Date
    March 16, 2018
    Manufacturer
    SILHOUETTE LIFT INC.
    Product Code
    GAM
    PMA / PMN Number
    K163676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A REVIEW IT WAS NOTED THAT THE DATE IN SECTION B4 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.

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED TO US THAT THE TREATING PHYSICIAN BELIEVED THAT THE THREADS HAD BEEN PLACED TOO SUPERFICIALLY IN THE SKIN AND THE NECK AREA. THE PHYSICIAN PROVIDED A PHOTOGRAPH WHICH ALSO APPEARED TO DEMONSTRATE A PROTRUSION OF THE MONOFILAMENT OR CONE IN THE NECK AREA. THE COMPANY MEDICAL ADVISOR ASSESSED THE AVAILABLE INFORMATION AND PROVIDED PHOTOGRAPH AND QUERIED IF THE ISSUE RELATED TO AN ENTRY OR EXIT POINT OF THE MONOFILAMENT OR A CONE POINTING THROUGH THE DERMIS. HE IS OF THE OPINION THAT SHOULD INFLAMMATION PERSIST, TO CONSIDER THE REMOVAL OF THE PRODUCT AT THE INFLAMED POINT. IN ADDITION, HE IS OF THE OPINION THAT IF INFECTION DOES NOT OCCUR, THEN THE EVENT WOULD NOT BE CONSIDERED AS A RISK TO RESULT IN A SERIOUS DETERIORATION IN HEALTH TO THE PATIENT OR A LIFE THREATENING SITUATION. SINCLAIR IS REPORTING THIS EVENT OUT OF TRANSPARENCY DUE TO THE POTENTIAL FOR DETERIORATION IN HEALTH TO THE PATIENT. LIMITED TREATMENT INFORMATION WAS PROVIDED REGARDING THIS EVENT AND THE PHYSICIAN DID NOT WISH TO DISCLOSE ANY FURTHER INFORMATION NOR WISH TO BE CONTACTED AGAIN. THE PATIENT'S TREATMENT DETAILS WERE NOT PROVIDED, NOR IS IT KNOWN IF THE PATIENT SUFFERS FROM ANY PRE-EXISTING MEDICAL CONDITIONS OR HAS ANY RELEVANT MEDICAL HISTORY. THE TREATING PHYSICIAN ADVISED THAT THERE HAD BEEN A MISTAKE ON THE COMMUNICATION AND THAT ALL IS FINE. THE USE OF SILHOUETTE INSTALIFT IS INDICATED FOR USE IN MID-FACE SUSPENSION SURGERY; USE OF SILHOUETTE INSTALIFT IN THE NECK IS CONTRA-INDICATED AND CONSIDERED OFF-LABEL USE. ALTHOUGH LIMITED INFORMATION WAS AVAILABLE REGARDING THE EVENT, THE ROOT CAUSE OF THIS ISSUE POTENTIALLY RELATES TO OFF-LABEL USE OF THE PRODUCT IN A CONTRAINDICATED AREA. A BATCH NUMBER FOR THE INVOLVED PRODUCT WAS NOT PROVIDED. THE DISTRIBUTOR PROVIDED A LIST OF BATCHES THAT WERE SENT TO THIS PHYSICIAN OVER THE LAST YEAR. UPON REVIEW OF THE LIST OF BATCHES PROVIDED THERE APPEARS TO BE NO TREND IN THE BATCH NUMBER AND ADVERSE EVENT REPORTED. THERE APPEARS TO BE NO OTHER REPORTS OF A SIMILAR NATURE ASSOCIATED WITH SILHOUETTE INSTALIFT NOR ANY OTHER REPORTS OF ADVERSE EVENTS FROM THIS PHYSICIAN.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2018 THAT A PATIENT HAD EXPERIENCED SOME ISSUES FOLLOWING TREATMENT WITH SILHOUETTE INSTALIFT. THE TREATING PHYSICIAN CONTACTED A REPRESENTATIVE OF THE DISTRIBUTOR FOR SILHOUETTE INSTALIFT IN THE USA REPORTING THAT THEY BELIEVED THE THREADS HAD BEEN PLACED TOO SUPERFICIALLY IN THE NECK AREA. A PHOTOGRAPH WAS PROVIDED. THE TREATING PHYSICIAN WAS RELUCTANT TO RESPOND TO THE DISTRIBUTORS REQUESTS FOR ADDITIONAL INFORMATION. AFTER FOLLOW UP INFORMATION WAS RECEIVED FROM THE TREATING PHYSICIAN, IT BECAME CLEAR THAT THERE HAD BEEN A MISTAKE REGARDING THE COMMUNICATION AND THAT ALL WAS FINE. THEY REQUESTED NOT TO BE CONTACTED FURTHER THROUGH CALLS OR EMAILS REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265798 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SILHOUETTE LIFT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other