BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 18434719 · Received January 3, 2024

    Report

    Report Number
    3007009755-2024-00001
    Event Type
    Injury
    Date Received
    January 3, 2024
    Date of Event
    September 15, 2023
    Report Date
    December 4, 2023
    Manufacturer
    SINCLAIR PHARMA US INC.
    Product Code
    GAM
    PMA / PMN Number
    K200140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING COMMENT: A BATCH INVESTIGATION CONFIRMS THAT LOT 0454-30 WAS MANUFACTURED AND RELEASED WITHIN SPECIFICATION ON 13-DEC-2022. A BATCH INVESTIGATION CONFIRMS THAT LOT 0460-31 WAS MANUFACTURED AND RELEASED WITHIN SPECIFICATION ON 28-MAR-2023. FOR BOTH LOTS, THERE IS NO INDICATION OF ANY BATCH OR PRODUCT RELATED DEFECT. LOT NUMBER: 0454-30 - EXPIRY DATE: 01-MAY- 2024 AND MANUFACTURE DATE: 01-NOV-2022. LOT NUMBER: 0460-31 - EXPIRY DATE: 01-AUG- 2024 AND MANUFACTURE DATE: 01-FEB-2023. CLINICAL COMMENT: OUR MEDICAL ADVISOR IS OF THE OPINION THAT IT LOOKS LIKE AN INFECTION. SOMEHOW, THE SUTURES WERE CONTAMINATED, AND IT CREATED A LOW-GRADE, CLINICAL INFECTION. HE ADVISED TO REMOVE THE SUTURES. HE IS OF THE OPINION THAT THE SUTURE PLACEMENT LOOKS SUPERFICIAL. OTHER COMMENT: THE RMF LISTS THAT A PATIENT MAY EXPERIENCE AN INFECTION DUE TO: ·TOO SUPERFICIAL PLACEMENT OF THE SUTURE. ·INSUFFICIENT TRIMMING OF THE SUTURE. ·THE PHYSICIAN NOT ADEQUATELY STERILISING THE SKIN PRIOR TO TREATMENT. ·THE PHYSICIAN CONTAMINATING THE SUTURE WHICH IS SUBSEQUENTLY ·INSERTED INTO THE PATIENT. THE PHYSICIAN NOT MAINTAINING A STERILE ENVIRONMENT DURING TREATMENT. CONCLUSION: BASED ON THE INFORMATION AVAILABLE, THE MOST LIKELY ROOT CAUSE HAS BEEN DETERMINED AS USER ERROR; WHERE THE PHYSICIAN MAY HAVE PLACED THE SUTURES TOO SUPERFICIALLY.

    Description of Event or Problem · 0

    ON (B)(6) 2023 A PATIENT RECEIVED TREATMENT WITH SILHOUETTE INSTALIFT TO THE FACE. 2 WEEKS POST TREATMENT THE PATIENT DEVELOPED RED NODULES ON LEFT SIDE OF FACE ALONG UPPER SUTURE LINE. CULTURE TAKEN OF PURULENCE WAS NEGATIVE. PATIENT TREATED WITH CLINDAMYCIN PILLS AND IMPROVED, BUT HAD GI ISSUES AND WAS SWITCHED TO BACTRIM PILLS. INTRALESIONS TRIAMCINOLONE INJECTED, WHICH HELPED THE SWELLING. ON FOLLOW-UP ON 06-NOV-23, SHE WAS GETTING NEW LESIONS. BACTRIM NOT HELPING, SO IT WAS CHANGED TO MINOCYCLINE 100 BID (TWICE A DAY) AND CLARITHROMYCIN 250MG BID FOR 2-4 MONTHS, AS DETERMINED BY RESOLUTION. INTRALESIONAL 5-FU ALSO INJECTED ON (B)(6) 2023 TO AVOID ATROPHY. AWAITING THE NEXT FOLLOW-UP APPOINTMENT, BUT PATIENT NOT RESOLVED YET. AS OF 28-DEC-2023 SINCLAIR HAVE NOT RECEIVED ANY FURTHER UPDATES, DESPITE REQUESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762661 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SINCLAIR PHARMA US INC. 0454-30, 0460-31

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention