BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 9640959 · Received January 29, 2020

    Report

    Report Number
    3007009755-2020-00001
    Event Type
    Injury
    Date Received
    January 29, 2020
    Report Date
    February 6, 2020
    Manufacturer
    SILHOUETTE LIFT INC.
    Product Code
    GAM
    PMA / PMN Number
    K163676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER COMMENT: FOLLOWING A STERILITY TEST ON A RETAINED SAMPLE OF LOT 0369-28, IT WAS CONFIRMED THAT NO BACTERIAL GROWTH WAS PRESENT. CLINICAL COMMENT: THE TREATING PHYSICIAN INITIALLY ADVISED THAT PART OF THE SILHOUETTE INSTALIFT THREAD MAY HAVE BEEN TOO SUPERFICIALLY PLACED. THE PHYSICIAN USED SUBCISION TO INCREASE THE SPACE BETWEEN THE SUPERFICIAL DERMIS AND THE IMPLANTED PRODUCT STATED THAT THE THREAD HAD NOT BEEN TOO SUPERFICIALLY PLACED. A COMPANY MEDICAL ADVISOR IS OF THE OPINION THAT THE SILHOUETTE INSTALIFT THREAD HAD, MOST LIKELY, BEEN PLACED TOO SUPERFICIALLY. IT IS NOTED THAT THE PATIENT DID NOT FOLLOW THE TREATING PHYSICIAN'S TREATMENT RECOMMENDATION AND THIS APPEARS TO HAVE EXACERBATED THE ADVERSE EVENT. ADDITIONAL COMMENTS: NO OTHER REPORTED ADVERSE EVENTS OF A SIMILAR NATURE AND IN ASSOCIATION WITH THE TREATING PRACTITIONER HAVE BEEN RECEIVED. CONCLUSION: POTENTIAL ROOT CAUSES ARE: TOO SUPERFICIAL PLACEMENT, PATIENT INFLAMMATORY REACTION, UNDERLYING MEDICAL CONDITION. THERE IS NO EVIDENCE TO SUGGEST A PRODUCT DEFECT.

    Description of Event or Problem · 0

    THE PATIENT ATTEMPTED TO DRAIN THE AFFECTED AREAS PRIOR TO OBTAINING MEDICAL ADVICE FROM THE TREATING PHYSICIAN. ON (B)(6) 2020 THE PATIENT REPORTED HAVING BEEN REVIEWED BY A PLASTIC SURGEON WITH A VIEW TO HAVING THE THREAD REMOVED. THE PLASTIC SURGEON REPORTEDLY COULD NOT LOCATE THE SILHOUETTE INSTALIFT THREAD IN SITU (NO OFFICIAL RESULTS PROVIDED TO SINCLAIR). THE PATIENT HAS DECLINED SYSTEMIC STEROID TREATMENT TO TREAT THE EVENT AS RECOMMENDED BY HER TREATING PHYSICIAN AND A COMPANY EXPERT.

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMMENT: A REVIEW OF THE BATCH RECORDS CONFIRMED THAT LOT 0369-28 WAS MANUFACTURED AND RELEASED IN ACCORDANCE WITH SET SPECIFICATIONS. THERE IS NO EVIDENCE TO SUGGEST A PRODUCT DEFECT. A BATCH TREND REVIEW SHOWS TWO OTHER EVENT IN ASSOCIATION WITH LOT 0369-28: AN EXTRUDING SUTURE AND PAIN (SINCLAIR REF: (B)(4)); AN ABSCESS AND HEMATOMA ((B)(4)). RETAINED SAMPLE TESTING ON LOT 0369-28 HAS BEEN REQUESTED AND THE RESULTS WILL BE SUBMITTED WITHIN A FOLLOW UP REPORT. CLINICAL COMMENT: THE INVESTIGATION IS ONGOING AND CLINICAL COMMENTS WILL BE PROVIDED WITHIN A FOLLOW UP REPORT. CONCLUSION: THE INVESTIGATION IS ONGOING AND THE INVESTIGATION CONCLUSION WILL BE PROVIDED WITHIN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT TREATMENT WITH SILHOUETTE INSTALIFT ON (B)(6) 2019. A SUTURE WAS INSERTED INTO EACH SIDE OF THE FACE ALONG THE JAWLINE. FOLLOWING TREATMENT, THE PATIENT EXPERIENCED DIMPLING WHICH RESOLVED WITHOUT TREATMENT. ON (B)(6) 2019, THE PATIENT REPORTED SWELLING ON THEIR RIGHT SIDE. THE PHYSICIAN ADVISED THAT THE PATIENT WAS EXPERIENCING REDNESS AND PEELING SKIN FROM RETIN-A (VITAMIN A) TREATMENT AND FROM THE PATIENT PALPATING THE AREA. THE PHYSICIAN RECOMMENDED MEDROL (STEROID) TREATMENT HOWEVER THE PATIENT DID NOT WISH TO TAKE THIS TREATMENT. IN ADDITION, AN EXTRUDING CONE WAS TREATED BY SUBCISION. ON AN UNSPECIFIED DATE, OTHER AREAS OF THE PATIENTS FACE WERE REPORTED TO HAVE BECOME INFLAMED. ON (B)(6) 2019, THE PHYSICIAN INJECTED KENALOG (STEROID TREATMENT) INTO THE VISIBLE/PALPABLE LESIONS AND THE PATIENT REPORTED AN IMPROVEMENT. ON (B)(6) 2019, THE PATIENT REPORTED EXPERIENCING A NEW REGION OF SWELLING. THE PHYSICIAN ADVISED THAT AREA WAS RED AND TENDER WHEN PALPATING. THE PHYSICIAN RECOMMENDED THAT THE PATIENT TAKE MEDROL (STEROID TREATMENT) AND DOXYCYCLINE (ANTIBIOTICS). ON (B)(6) 2019, THE PATIENT BEGAN A COURSE OF DOXYCYCLINE ANTIBIOTICS AND SQUEEZED A LESION TO RELEASE FLUID. ON (B)(6) 2019, THE PHYSICIAN INJECTED KENALOG. FOLLOWING TREATMENT, THE PATIENT REPORTED AN IMPROVEMENT OF THE SYMPTOMS. ON (B)(6) 2019, THE PHYSICIAN NOTED AN IMPROVEMENT AND THE PATIENT UNDERWENT A LIGHT TREATMENT FOR REDNESS OF THE AREA. THE PATIENT DISCONTINUED THE DOXYCYCLINE ANTIBIOTICS AND SUBSEQUENTLY THEIR CONDITION DETERIORATED . SHE LATER RESUMED ANTIBIOTIC TREATMENT. ON (B)(6) 2020, THE PATIENT WAS REPORTED TO BE IMPROVING. THE PATIENT HAS ALSO RECEIVED THE FOLLOWING TREATMENTS: NANO SILVER GEL, LED TREATMENT, PROBIOTIC TREATMENT (THE PATIENT LATER DISCONTINUED THIS TREATMENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104718 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SILHOUETTE LIFT INC. 0369-28

    Patients

    Seq Age Sex Outcome Treatment
    1 Other