BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 8239209 · Received January 11, 2019

    Report

    Report Number
    3007009755-2019-00001
    Event Type
    Injury
    Date Received
    January 11, 2019
    Report Date
    December 12, 2018
    Manufacturer
    SILHOUETTE LIFT INC.
    Product Code
    GAM
    PMA / PMN Number
    K163676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2019 THE PHYSICIAN PROVIDED THE LOT NUMBER OF THE PRODUCT USED. FOLLOWING A REVIEW OF THE BATCH RECORDS FOR THE REPORTED LOT IT CAN BE CONFIRMED THAT THE BATCH WAS MANUFACTURED, STERILIZED AND RELEASED PER THE SET SPECIFICATIONS, WITH NO EVIDENCE OF ANY STERILITY ISSUE. IN ADDITION, THERE ARE NO OTHER REPORTS OF ANY EVENTS OF ABSCESS, INFLAMMATION, INFECTION AND PUS ASSOCIATED WITH THIS BATCH. THE EVENT DOES NOT APPEAR RELATED TO THE SUPPLY CHAIN OR DISTRIBUTION OF THE PRODUCT. THE PROBABLE ROOT CAUSE OF THE EVENT IS NON-ASEPTIC TREATMENT CONDITIONS OR POOR PATIENT AFTERCARE FOLLOWING TREATMENT. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2018 THE PATIENT WAS TREATED WITH SILHOUETTE INSTALIFT BY PHYSICIAN. ON (B)(6) 2018 THE PATIENT VISITED THE PHYSICIAN FOR A ROUTINE FOLLOW-UP REVIEW APPOINTMENT FOLLOWING INITIAL TREATMENT. THE PHYSICIAN STATED THAT ALL SUTURE TRACKS WERE INFLAMED & ENGORGED WITH PUS. THE PHYSICIAN WAS ABLE TO PERFORM INCISION AND DRAINAGE TO ALL AREAS ALONG THE TRACKS. AT THE SAME TIME A CULTURE WAS TAKEN AND THE PATIENT WAS STARTED ON ANTIBIOTICS ((B)(6)) IN CASE IT WAS A (B)(6) INFECTION. (ON B)(6) 2018 THE PHYSICIAN ADVISED THAT THE PATIENT IS RECOVERING. ON (B)(6) 2018 THE PHYSICIAN ADVISED THAT THE CULTURE SHOWED MODERATE GROWTH OF (B)(6) TO (B)(6). (B)(6) 2018 THE PHYSICIAN ADVISED THAT THE PATIENT IMPROVED ON (B)(6) (TWICE A DAY) AND THAT PAIN HAD REDUCED. IT WAS REPORTED THAT THE SUTURE TRACKS WERE STILL SWOLLEN AND PALPABLE AND SOME EXUDATE WITH TINTED BLOOD WAS DRAINED OUT ON THE RIGHT SIDE OF THE FACE & RIGHT UPPER NECK. (NO EXUDATE WAS PRESENT ON THE LEFT SIDE OF THE FACE OR THE LEFT UPPER NECK.) THE PHYSICIAN INDICATED THAT (B)(6) SHALL BE CONTINUED FOR AT LEAST 15 DAYS. ON (B)(6) 2019 THE PHYSICIAN SPOKE WITH THE PATIENT. THE INFECTION HAS SUBSIDED WITH THE ANTIBIOTIC TREATMENT AND THE PATIENT WILL RETURN FOR FURTHER TREATMENT WITH SILHOUETTE INSTALIFT IN SPRING 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34652 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SILHOUETTE LIFT INC. 0377-28

    Patients

    Seq Age Sex Outcome Treatment
    1 Other