BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 8141754 · Received December 7, 2018

    Report

    Report Number
    3007009755-2018-00004
    Event Type
    Injury
    Date Received
    December 7, 2018
    Report Date
    November 14, 2018
    Manufacturer
    SILHOUETTE LIFT INC.
    Product Code
    GAM
    PMA / PMN Number
    K163676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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 DATE OF REPORT.

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT WAS IMPLANTED IN THE PATIENT IT WAS NOT RETURNED FOR INVESTIGATION. THIS EVENT WAS BROUGHT TO OUR ATTENTION FROM A SECOND PHYSICIAN WHO TREATED THE PATIENTS ADVERSE EVENT. THE BATCH NUMBER WAS NOT AVAILABLE AND THEREFORE THE BATCH RECORDS COULD NOT BE REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFECT. A COMPANY MEDICAL ADVISOR REMOTELY ASSESSED THE AVAILABLE INFORMATION AND INDICATED THAT THERE WAS A TECHNICAL ERROR DURING TREATMENT, WHICH RESULTED IN THE INITIAL DIMPLE FORMATION. HE IS OF THE OPINION THAT THE PATIENT LIKELY EXPERIENCED INFLAMMATION DUE TO THE MEDICAL INTERVENTION OF THE OPENING OF THE SKIN AND THAT THE AREA BECAME INFECTED. FOLLOWING THE PROVISION OF PATIENT PHOTOGRAPHS, THE COMPANY ADVISOR IS OF THE OPINION THAT THERE HAD BEEN A PROBLEM IN THE HEALING OF THE ENTRY POINT, POTENTIALLY DUE THE OPENING OF THE AREA OR DUE TO PRESSURE FROM A CONE. (B)(4) HAS RECEIVED NO OTHER EVENTS ASSOCIATED WITH THE TREATING PHYSICIAN. THIS EVENT HAS BEEN EVALUATED, INCLUDING THE OVERALL RISK TO PATIENT, AND NO SPECIFIC CORRECTIVE ACTIONS HAVE BEEN IDENTIFIED AS NECESSARY (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2018 - THE PATIENT RECEIVED TREATMENT WITH SILHOUETTE INSTALIFT. ON (B)(6) 2018 - THE PATIENT PRESENTED TO A SECOND PHYSICIAN, AS CLOSER TO HOME, WITH SEVERE DIMPLING IN THE RIGHT MEDIAL CHEEK. THEY UNDERWENT A SUBCISION WITH A 16G NEEDLE WHICH IMPROVED THE ISSUE. ON (B)(6) 2018 - THE ANTERIOR, INFERIOR PORTION OF THE SUTURE WAS TOO LONG AND PROTRUDING AGAINST THE SKIN; THIS WAS RESECTED. ON (B)(6) 2018 - THE PATIENT WAS REVIEWED AND EXHIBITED CELLULITIS. SHE REPORTED A PREVIOUS HISTORY OF (B)(6) AND WAS PRESCRIBED ORAL ANTIBIOTICS (CIPRO 400 MG EVERY 8 HOURS, FOR TEN DAYS). ON (B)(6) 2018 - THE PATIENT VISITED THE CLINIC, DUE TO CONCERNS ABOUT INADEQUATE RESOLUTION OF CELLULITIS; A BACTERIOLOGICAL CULTURE WAS SENT FOR ANALYSIS WHICH SHOWED NO GROWTH IN THE FINAL REPORT. ON (B)(6) 2018 - THE PATIENT WAS CALLED ON WITH THE CULTURE RESULTS. DUE TO PERSISTENT REDNESS AND CONCERN ON THE PATIENTS PART, CLINDAMYCIN (500MG) WAS ADDED TO THE PATIENT TREATMENT. ON (B)(6) 2018 - THE PATIENT WAS CALLED AND SHE ADVISED THAT THE ANTIBIOTICS WERE HELPING AND SHE FELT HER OPEN WOUND WAS HEALING. ON (B)(6) 2018 - THE CLINIC MESSAGED THE PATIENT TO MAKE AN APPOINTMENT. THE PATIENT CONTACTED THE CLINIC AND ARRANGED AN APPOINTMENT FOR (B)(6) 2018; HOWEVER, SHE DID NOT ATTEND AND HAS NOT VISITED THE CLINIC SINCE. ON (B)(6) 2018 - THE PATIENT WAS CONTACTED BY PHONE AND REPORTED THAT SHE WAS DOING FINE; SHE IS EXPERIENCING A SMALL BUMP ON THE RIGHT CHEEK. THE PATIENT DECLINED TO VISIT THE CLINIC FOR REVIEW. ON (B)(4) 2018 - THIS EVENT WAS BROUGHT TO THE ATTENTION OF SILHOUETTE LIFT INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981992 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SILHOUETTE LIFT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other