BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 14174665 · Received April 21, 2022

    Report

    Report Number
    2210968-2022-02849
    Event Type
    Injury
    Date Received
    April 21, 2022
    Date of Event
    March 3, 2021
    Report Date
    April 21, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? PLEASE VERIFY WHAT COUNTRY THE STUDY WAS CONDUCTED THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. DOI HTTPS://DOI.ORG/10.1055/S-0041-1722907.

    Description of Event or Problem · 0

    TITLE: THE MULTIPLE RHOMBOID VECTOR SUTURE¿OUR EXPERIENCE OF TWO YEARS WITH A MODIFIED SUSPENSION APPROACH FOR SMAS PLICATION FACELIFTS. THE AIM OF THIS STUDY IS TO PRESENT THE AUTHORS' NEW APPROACH NAMED THE MULTIPLE RHOMBOID VECTOR (MRV) SUTURE. A TOTAL OF 103 PATIENTS (89 FEMALE, 14 MALE; MEDIAN AGE WAS 57 YEARS [RANGE: 43¿74 YEARS]) RECEIVED A PRIMARY RHYTIDECTOMY WITH THE MULTIPLE RHOMBOID VECTOR (MRV) SUPERFICIAL MUSCULOAPONEUROTIC SYSTEM (SMAS) PLICATION SUTURE BETWEEN JUNE 2015 AND MAY 2017. SMAS PLICATION IS PERFORMED AFTERWARD WITH AN INTERLOCKED RUNNING 2¿0 VICRYL SUTURE FORMING TWO INTERLOCKING RHOMBI, WHICH INTERACT LIKE PARALLELOGRAMS UNDER TENSION (¿FIG. 1). SKIN CLOSURE IS PERFORMED WITH INVERTED SUBDERMAL 4¿0 VICRYL SINGLE SUTURES FOLLOWED BY 4¿0 ETHILON TRANSDERMAL SINGLE STITCHES RETROAURICULAR AND A RUNNING 4¿0 ETHILON INTRADERMAL SUTURE PREAURICULAR/TEMPORAL HAIRLINE. THE MEAN FOLOW-UP TIME WAS 6 MONTHS. REPORTED COMPLICATIONS INCLUDE RETROAURICULAR HEMATOMA (N=2) WHICH COULD BE DRAINED BEDSIDE IN CONCLUSION, THE MRV SUTURE TECHNIQUE HAS BEEN SHOWN TO ENHANCE THE ESTHETIC OUTCOME OF SMAS PLICATION OR STACKING APPROACHES WITH EQUAL COMPLICATION RATES COMPARED WITH OTHER SURGICAL FACELIFT TECHNIQUES. MOREOVER, IT MAY HELP REDUCE THE POSSIBILITY OF CONTOUR IRREGULARITIES AND CREATE LONG-LASTING ESTHETICALLY PLEASING RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2619062 ETHILON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention