BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 9178271 · Received October 11, 2019

    Report

    Report Number
    3007009755-2019-00005
    Event Type
    Injury
    Date Received
    October 11, 2019
    Date of Event
    August 2, 2019
    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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING COMMENT: RETAINED SAMPLE TESTING HAS BEEN REQUESTED AND THE RESULTS WILL BE SUBMITTED WITHIN A FOLLOW-UP REPORT. CLINICAL COMMENT: TWO COMPANY MEDICAL ADVISORS ARE OF THE OPINION THAT THE EVENT IS LIKELY TO BE AS A RESULT OF TOO SUPERFICIAL PLACEMENT OF THE SUTURES AND NON-ASEPTIC TREATMENT CONDITIONS AND/OR POOR PATIENT AFTERCARE. THE INVESTIGATION IS ONGOING AND ANY ADDITIONAL INFORMATION WILL BE PROVIDED WITHIN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    MANUFACTURING COMMENT: FOLLOWING A STERILITY TEST ON A RETAINED SAMPLE OF LOT 0398-28, IT WAS CONFIRMED THAT NO BACTERIAL GROWTH WAS PRESENT. A BATCH TREND REVIEW SHOWS ONE OTHER ADVERSE EVENT ASSOCIATED WITH LOT 0398-28, FDA REF: 3007009755-2019-00010 (INTERNAL REFERENCE (B)(4)). ADDITIONAL INFORMATION: THE PHYSICIAN RECEIVED ADDITIONAL TRAINING ON 18-OCT-2019. A REVIEW OF ALL ADVERSE EVENTS REPORTED TO SILHOUETTE LIFT INC. CONFIRM NO OTHER REPORTED ADVERSE EVENTS OF A SIMILAR NATURE IN ASSOCIATION WITH THE TREATING PRACTITIONER. CONCLUSION: NO PRODUCT DEFECT HAS BEEN HIGHLIGHTED. POTENTIAL ROOT CAUSES MAY RELATE TO: A FOREIGN BODY REACTION, TOO SUPERFICIAL PLACEMENT OF THE SUTURES, NON-ASEPTIC TREATMENT CONDITIONS, POOR PATIENT AFTERCARE, OTHER AESTHETIC TREATMENTS I.E. DERMAL FILLERS, UNDERLYING MEDICAL CONDITION.

    Additional Manufacturer Narrative · 1

    MANUFACTURING COMMENT: A REVIEW OF THE BATCH RECORDS CONFIRM THAT LOT 0398-28 WAS MANUFACTURED AND RELEASED WITHIN SET SPECIFICATIONS. THERE IS NO EVIDENCE OF A PRODUCT DEFECT. A BATCH TREND REVIEW SHOWS NO OTHER ADVERSE EVENTS ASSOCIATED WITH THIS LOT. CLINICAL COMMENT: A SINCLAIR COMPANY EXPERT IS OF THE OPINION THAT THE PATIENT HAS EXPERIENCED A FOREIGN BODY REACTION AND THAT WITH CONTINUED TREATMENT, THE PATIENT'S SYMPTOMS WILL RESOLVE. CONCLUSION: NO PRODUCT DEFECT HAS BEEN HIGHLIGHTED. THE PROBABLE ROOT CAUSE IS A FOREIGN BODY REACTION. SINCLAIR PHARMACEUTICALS LTD. (REGISTRATION NUMBER (B)(4)) IS SUBMITTING THIS REPORT ON BEHALF OF SILHOUETTE LIFT INC.(REGISTRATION NUMBER (B)(4)).

    Description of Event or Problem · 1

    A PATIENT UNDERWENT TREATMENT IN THE FACE WITH SILHOUETTE INSTALIFT ON (B)(6) 2019. ONE WEEK POST TREATMENT, THE PATIENT EXPERIENCED REDNESS AND SWELLING ON THE RIGHT SIDE OF THE FACE. ALTHOUGH THE PATIENT'S CONDITION IMPROVED, FOLLOWING RUPTURE AND DRAINAGE OF THE AFFECTED AREA, THE PATIENT SUBSEQUENTLY EXPERIENCED THE SAME SYMPTOMS ON THE LEFT SIDE OF THE FACE, INCLUDING MULTIPLE NODULES BILATERALLY THAT WERE NOT PURULENT. THE TREATING PHYSICIAN INITIALLY PRESCRIBED KEFLEX (CEFALEXIN) AND A WARM COMPRESS. ADDITIONALLY, THE PATIENT UNDERWENT TESTING FOR CULTURE AND SENSITIVITY FOR WHICH THE RESULTS WERE NEGATIVE. THE PATIENTS ANTIBIOTICS WERE SUBSEQUENTLY CHANGED TO BACTRIM (TRIMETHOPRIM/SULFAMETHOXAZOLE) AND SHE UNDERWENT TREATMENT WITH INTRALESIONAL STEROID INJECTIONS. THE TREATING PHYSICIAN RECOMMENDED TREATMENT WITH MEDROL HOWEVER IF THIS DOES NOT BRING ABOUT ANY IMPROVEMENT THEN TO MAINTAIN A TREATMENT PLAN OF INTRALESIONAL STEROID INJECTIONS WITH 5FU, FOLLOWED BY IPL LASER THERAPY. THE PATIENT IS BEING REVIEWED BY A SECOND PHYSICIAN FOR FOLLOW UP OF THE ADVERSE EVENT, WHICH IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975460 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SILHOUETTE LIFT INC. 0398-28

    Patients

    Seq Age Sex Outcome Treatment
    1 Other