BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 8188649 · Received December 21, 2018

    Report

    Report Number
    3007009755-2018-00005
    Event Type
    Injury
    Date Received
    December 21, 2018
    Report Date
    January 8, 2019
    Manufacturer
    SILHOUETTE LIFT INC.
    Product Code
    GAM
    PMA / PMN Number
    K163676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DESPITE SEVERAL REQUESTS, NO FURTHER UPDATES ON THE PATIENT'S CURRENT HEALTH STATUS HAVE BEEN RECEIVED FROM THE TREATING PHYSICIAN. 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 PHYSICIAN WAS CONDUCTED AND ALL 3 LOTS WERE FOUND TO HAVE BEEN MANUFACTURED AND RELEASED IN ACCORDANCE WITH SET SPECIFICATIONS. THERE IS CURRENTLY NO EVIDENCE TO SUGGEST A PRODUCT DEFECT. THERE ARE NO OTHER REPORTS OF SIMILAR EVENTS ASSOCIATED WITH ANY OF THE 3 LOT NUMBERS AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED IN ASSOCIATION WITH THIS PHYSICIAN. THIS EVENT HAS BEEN EVALUATED AND NO SPECIFIC CORRECTIVE ACTIONS HAVE BEEN IDENTIFIED AS NECESSARY. SINCLAIR PHARMACEUTICALS LTD. (REGISTRATION NUMBER (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF SILHOUETTE LIFT INC.(REGISTRATION NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT WAS IMPLANTED IN THE PATIENT IT WAS NOT RETURNED FOR INVESTIGATION. TO DATE THE LOT NUMBER HAS NOT BEEN PROVIDED. A COMPANY MEDICAL ADVISOR SPOKE WITH THE PHYSICIAN AND WAS OF THE OPINION THAT THE FEVER MAY BE COINCIDENTAL AND THAT THE PATIENT MAY HAVE CONCOMITANT INFLUENZA OR ANOTHER UNDERLYING ILLNESS THAT IS CAUSING THE ISSUE. IT WAS LATER REPORTED ON (B)(6) 2018 THAT THE PATIENT HAS AN AUTOIMMUNE DISEASE WHICH SHE DID NOT DISCLOSE TO HER TREATING PHYSICIAN. THE SILHOUETTE INSTALIFT INSTRUCTIONS FOR USE LISTS ACUTE INFLAMMATORY TISSUE REACTION AS A POTENTIAL ADVERSE EVENT THAT COULD OCCUR AS A RESULT OF TREATMENT HOWEVER THE UNDERLYING AUTOIMMUNE DISEASE COULD BE A FACTOR. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A NOTIFICATION WAS RECEIVED ON (B)(6) 2018 IN RELATION TO A PATIENT EXPERIENCING FEVER ON AND OFF FOLLOWING THEIR TREATMENT WITH SILHOUETTE INSTALIFT. IT WAS REPORTED THAT THE PATIENT HAD VISITED THE EMERGENCY ROOM. A NOTIFICATION WAS ALSO RECEIVED DIRECTLY FROM THE PATIENT ON (B)(6) 2018 WHERE THE PATIENT REPORTED THAT SHE HAD EXPERIENCED A REACTION TO THE SUTURES AND IS EXPERIENCING A FEVER, WITH SWELLING IN THE LYMPH NODE AREA. THE PATIENT ADVISED THAT SHE HAD VISITED THE EMERGENCY ROOM IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE BLOOD CULTURE TESTING AND WAS AWAITING AN MRI SCAN. THE RESULTS OF THESE TESTS HAVE NOT AT THIS STAGE BEEN PROVIDED. THE PATIENT WAS RECOMMENDED TO RETURN TO HER TREATING PHYSICIAN. THE PHYSICIAN REVIEWED THE PATIENT ON (B)(6) 2018 AND DOES NOT BELIEVE THAT THERE WAS LYMPH NODE SWELLING BUT SWELLING AROUND THE SUTURE DUE TO PLACEMENT. THE PATIENT HAS TAKEN TYLENOL AND WAS REPORTED TO BE IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028325 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SILHOUETTE LIFT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other