BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEATHERLIFE SILHOUETTE SUTURE

    MDR report key: 4287638 · Received November 21, 2014

    Report

    Report Number
    3007009755-2014-00001
    Event Type
    Injury
    Date Received
    November 21, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 5, 2014
    Manufacturer
    SILHOUETTE LIFT INC.
    Product Code
    GAM
    PMA / PMN Number
    K060414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INVESTIGATION INTO THIS ISSUE CONTINUES. AT THIS TIME THIS WOULD APPEAR TO BE AN ISOLATED CASE, WITH NO OTHER SIMILAR REPORTED CASES TO DATE WITH THIS OR SIMILAR PRODUCTS. THE POTENTIAL FOR LIFE THREATENING OR SERIOUS DETERIORATION WOULD APPEAR VERY LOW. THE DEVICE HAS NOT BEEN RETURNED AS IT WAS SUCCESSFULLY IMPLANTED INTO THE PATIENT. A F/U REPORT SHALL SUBMITTED ON CONCLUSION OF THE COMPLAINT INVESTIGATION.

    Description of Event or Problem · 1

    AS DESCRIBED BY THE PATIENT: "DR (B)(6) DID MY PROCEDURE AND REMOVED MY STITCHES, BUT BECAUSE I LIVE OVER 100 MILES FROM (B)(6) IT WAS HARD TO SCHEDULE APPOINTMENT WITH DR (B)(6). OUR SCHEDULES JUST DON'T MATCH UP SO DR. (B)(6) HAS BEEN THE DOCTOR WHO DID HIS VERY BEST TO HELP MY LEFT SIDE HEAL. THE PROCEDURE WAS DONE AROUND (B)(6) 2013, SINCE THEN MY LEFT SIDE WOULD HEAL MOST OF THE WAY, BUT THEN WOULD REOPEN AGAIN AND IT WOULD DO THIS OVER AND OVER AGAIN. I WAS TOLD IT WAS A HAIR GROWING IN THE AREA THAT KEEPS GETTING INFECTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758373 FEATHERLIFE 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 35 YR Required Intervention