BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 6816814 · Received August 24, 2017

    Report

    Report Number
    3007009755-2017-00002
    Event Type
    Injury
    Date Received
    August 24, 2017
    Report Date
    August 10, 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 IN SECTIONS B4 AND G4 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

    SINCLAIR WERE INFORMED ON THE (B)(6) 2017 THAT THE RED NODULES HAD DECREASED IN SIZE. ON THE (B)(6) 2017 SINCLAIR WERE ADVISED THAT THE PATIENT HAD IMPROVED AFTER STEROID INJECTION AND WAS TO BE REVIEWED THE FOLLOWING WEEK. AN UPDATE WAS PROVIDED FROM THE PRACTITIONER ON THE (B)(6) 2017 THAT THE PATIENT HAD BEEN REVIEWED ON THE (B)(6) 2017 AND RECEIVED TREATMENT WITH STEROID INJECTION. THE ISSUE WAS RESOLVING. SINCLAIR WERE INFORMED ON THE (B)(6) 2017 THAT THE PATIENT WAS REVIEWED ON (B)(6) 2017 AND WAS INJECTED WITH STEROID. THE ISSUE HAD ALMOST RESOLVED. SINCLAIR WERE INFORMED BY THE PRACTITIONER ON THE (B)(6) 2017 THAT THE ISSUE HAS COMPLETELY RESOLVED. OUR DISTRIBUTOR'S MEDICAL ADVISOR ASSESSED THE AVAILABLE INFORMATION AND DISCUSSED DIRECTLY WITH THE TREATING PRACTITIONER. THEY CONCLUDED THAT THE MOST LIKELY ROOT CAUSE RELATED TO SUBCUTANEOUS FRICTION FROM A LONG SUTURE AND MAY ALSO RELATE TO THE PROXIMITY OF THE SKIN TO THE CONE. THIS WOULD BE A POTENTIAL PHYSICIAN ERROR RATHER THAN A DEVICE MALFUNCTION. THE MEDICAL ADVISOR FURTHER COMMENTED THAT A POSSIBLE, BUT UNLIKELY ROOT CAUSE MAY RELATE TO A RARE CONNECTIVE TISSUE IDIOSYNCRATIC RESPONSE TO PLLA OR PLGA BY THE PATIENT. HE IS OF THE OPINION THAT NODULES CAN FORM AFTER INJECTION OF A PARTICULAR AQEUOUS SUSPENSION OF PLLA. THE MEDICAL ADVISOR FURTHER COMMENTED THAT AN INFECTION OR CONTAMINATION OF THE THREADS ARE HIGHLY UNLIKELY AND THAT AN ERROR IN THE MANUFACTURING, STERILIZATION OR OTHER SINCLAIR-ORIGINATED PROBLEM IS HIGHLY UNLIKELY AND ALMOST CERTAINLY NOT THE CASE. A BATCH RECORD REVIEW CONFIRMED THAT THE REPORTED LOT NUMBER WAS RELEASED PER SET SPECIFICATIONS AND THAT THERE IS NO PRODUCT OR MANUFACTURING HISTORY RELATED TO THE REPORTED EVENT OF NODULES.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS REVIEWED BY THE TREATING PRACTITIONER ON THE (B)(6) 2017 WHERE THEY PRESENTED WITH A NODULE OVER THE LEFT LOWER FACE AT THE SITE OF ENTRY. THEY RECEIVED TREATMENT WITH KENALOG INJECTION (STEROID) WITH SUBSEQUENT IMPROVEMENT IN 24 HOURS. THE PATIENT WAS REVIEWED A SECOND TIME ON THE (B)(6) 2017 AND PRESENTED WITH TWO NEW NODULES ON THE LEFT MID FACE. THEY RECEIVED FURTHER TREATMENT WITH KENALOG INJECTIONS. WE WERE INFORMED ON THE (B)(6) 2017 THAT ONE NODULE PERSISTS AND THE PATIENT RECEIVED TREATMENT WITH KENALOG. THE PATIENT WAS REVIEWED ON THE (B)(6) 2017 WHERE THE OLD NODULES WERE RESOLVING AFTER STEROID INJECTION. THE PATIENT IS EXPERIENCING NEW NODULES ON THE UPPER PORTIONS OF THE SUTURE AND RECEIVED TREATMENT WITH STEROID INJECTION. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT CORRESPONDS TO REFERENCE (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT TREATMENT WITH SILHOUETTE INSTALIFT. APPROXIMATELY 1 MONTH AFTER TREATMENT THE PATIENT EXPERIENCED AN ITCHY, RED NODULE. UPON FURTHER REVIEWS, THE PATIENT HAS EXPERIENCED FURTHER NODULES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596849 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SILHOUETTE LIFT INC 0286-28

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention