BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 9796613 · Received March 6, 2020

    Report

    Report Number
    3007009755-2020-00002
    Event Type
    Injury
    Date Received
    March 6, 2020
    Date of Event
    February 4, 2020
    Report Date
    February 6, 2020
    Manufacturer
    SINCLAIR PHARMA US INC.
    Product Code
    GAM
    PMA / PMN Number
    K163676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMMENT: A REVIEW OF THE BATCH RECORDS CONFIRMS THAT LOT 0402-28A WAS MANUFACTURED AND RELEASED IN ACCORDANCE WITH SET SPECIFICATIONS. THERE IS NO EVIDENCE TO SUGGEST A PRODUCT DEFECT. A BATCH TREND REVIEW SHOWS NO OTHER EVENTS OF A SIMILAR NATURE HAVE BEEN REPORTED IN ASSOCIATION WITH LOT 0402-28A CLINICAL COMMENT: A COMPANY MEDICAL ADVISOR IS OF THE OPINION THAT THE INFECTION MAY RELATE TO THE PATIENT'S UNDERLYING MEDICAL CONDITION (TYPE II DIABETES). THEY ADVISED THAT TYPE II DIABETES CAN DELAY THE PATIENTS HEALING TIME, WHICH INCREASES THE RISK OF INFECTION. CONCLUSION: THE PROBABLE ROOT CAUSE IS THE PATIENTS UNDERLYING MEDICAL CONDITION. A POTENTIAL ROOT CAUSE MAY RELATE TO POOR PATIENT AFTERCARE.

    Description of Event or Problem · 1

    ON (B)(6) 2020, A PATIENT UNDERWENT TREATMENT WITH 8 SILHOUETTE INSTALIFT SUTURES (4 TO EACH SIDE OF THE FACE). ON (B)(6) 2020, THE PATIENT CONTACTED THE TREATING PRACTITIONER TO REPORT A VISIBLE CONE IN THE RIGHT NASOLABIAL FOLD THAT WAS CAUSING IRRITATION. ON (B)(6) 2020, THE PATIENT WAS REVIEWED BY THE TREATING PRACTITIONER AND PRESENTED WITH AN EXTRUDING CONE ON THE RIGHT HAND SIDE OF THE FACE. THE PATIENT ALSO PRESENTED WITH AN INFECTION. THE PRACTITIONER REMOVED THE EXTRUDING CONE AND PRESCRIBED THE PATIENT ORAL ANTIBIOTICS (KEFLEX AND BACTRIM) TO TREAT THE INFECTION. THE PATIENT HAS RECEIVED THE FOLLOWING TREATMENTS: BACTRIM ANTIBIOTICS, REFLEX 500MG QID, (B)(6) (PAIN RELIEF), PREDNISONE TREATMENT (40 MG FOR DAYS). INCISION AND DRAINAGE OF THE AFFECTED AREA. REMOVAL OF THE CONE AND PART OF THE SUTURE. THE PATIENT IS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260353 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SINCLAIR PHARMA US INC. 0402-28A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other