BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEATHERLIFT SILHOUETTE SUTURE

    MDR report key: 4287625 · Received November 21, 2014

    Report

    Report Number
    3007009755-2014-00002
    Event Type
    Injury
    Date Received
    November 21, 2014
    Date of Event
    December 1, 2012
    Report Date
    December 12, 2012
    Manufacturer
    SILHOUETTE LIFT INC.
    Product Code
    GAM
    PMA / PMN Number
    K060414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INVESTIGATION INTO THIS ISSUE CONTINUES. THE POTENTIAL FOR LIFE THREATENING OR SERIOUS DETERIORATION WOULD APPEAR VERY LOW AND THE "POTENTIAL INFECTION" HAS NOT BEEN CONFIRMED. THE DEVICE HAS NOT BEEN RETURNED AS IT WOULD APPEAR TO HAVE BEEN SUCCESSFULLY IMPLANTED INTO THE PATIENT. A F/U REPORT SHALL BE SUBMITTED ON CONCLUSION OF THE COMPLAINT INVESTIGATION. THIS CASE WAS IDENTIFIED AS PART OF A RETROSPECTIVE REVIEW AND IS REPORTED IN CAUTION.

    Description of Event or Problem · 1

    AS DESCRIBED BY THE REPORTING PHYSICIAN. "I HAVE PLACED THE (B)(6) FEMALE ON AUGMENTIN -875MG BID X 10 DAYS FOR POSSIBLE INFECTION. IT WILL SEE THE PATIENT IN F/U IN 2 WEEKS FROM TODAY, SOONER IF HER CONDITION WORSENS. SHE REPORTS A 2-WEEK HISTORY OF LEFT CHEEK AND JOWL AREA SWELLING, WAXING AND WANING WITH NO FEVERS, CHILLS, LOCALIZED PAIN OR DRAINAGE, AND NOT ODONTOGENIC SYMPTOMS TISSUE IS SWOLLEN AND SOMEWHAT FIRM. NO ABSCESS OF FLUID POCKET IS SEEN ON ULTRASOUND OF THE SUBQ TISSUE ON EITHER SIDE OF THE FACE. THE REDNESS, INDURATION AND SWELLING IS LIMITED TO THE LEFT NLF AND JOWL AREAS,. THERE ARE NO SYMPTOMS ON THE RIGHT SIDE OF FACE OR INTO THE LEFT TEMPLE AREA. I WAS UNABLE TO DETERMINE IF PATIENT HAS HAD ANY DENTAL PROCEDURES RECENTLY DUE TO HER LIMITED ENGLISH VOCABULARY. I WILL TRY AND KEEP YOU INFORMED OF HER CONDITION. INCIDENTALLY SHE DID HAVE A SURGICAL FACE LIFT 10 MONTHS AGO IN RUSSIA. SHIS IS 6 MONTHS S/P SILHOUETTE MID-FACE LIFT WITH ME A HOGUE COSMETIC SURGERY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758490 FEATHERLIFT SILHOUETTE SUTURE SILHOUETTE LIFT SUTURE, GAM, 878, 4493 GAM SILHOUETTE LIFT INC. SMS01-PP-3.0.1-B-S

    Patients

    Seq Age Sex Outcome Treatment
    1 60+ Required Intervention