BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 14692037 · Received June 15, 2022

    Report

    Report Number
    2210968-2022-04565
    Event Type
    Injury
    Date Received
    June 15, 2022
    Date of Event
    September 1, 2021
    Report Date
    June 29, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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? WHAT SURGICAL OR MEDICAL INTERVENTION HAS BEEN PERFORMED? 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. COMPONENT CODE: (B)(4). CITATION: CHIN J AESTH PLAST SURG, SEP 2021; VOL. 32, NO. 9. DOI: 10.3969/J.ISSN .1673- 7040.2021.09.018.

    Additional Manufacturer Narrative · 0

    PC(B)(4). DATE SENT TO THE FDA: 6/29/2022 THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE DEATH OF THE PATIENTS DESCRIBED IN THE ARTICLE? 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?

    Description of Event or Problem · 0

    TITLE: TREATMENT AND ANALYSIS OF COMPLICATIONS AFTER THREAD-LIFT SUTURES FOR FACIAL REJUVENATION IN 142 PATIENTS. THE AIM OF THIS STUDY WAS TO EXPLORE THE POTENTIAL COMPLICATIONS ASSOCIATED WITH THREAD-LIFT SUTURES FOR FACIAL REJUVENATION, ANALYZE THE REASONS AND FIND IMPROVEMENT MEASURES. FROM (B)(6) 2013 TO (B)(6) 2020, 142 PATIENTS (2 MALES AND 140 FEMALES; AVERAGE AGE OF 35 YEARS [RANGED FROM 28 TO 62 YEARS]) WITH COMPLICATIONS AFTER THREAD-LIFT SUTURES FOR FACIAL REJUVENATION IN OTHER HOSPITAL WERE ADMITTED TO THE SCAR MINIMALLY INVASIVE TREATMENT CENTER, PLASTIC SURGERY HOSPITAL, (B)(6). AMONG THESE COMPLICATIONS, A 3-0 ETHIBOND ((B)(4), USA) NON-ABSORBABLE SUTURE WAS EXPOSED ONE WEEK AFTER CIRCULAR LIFTING OF TEMPORAL SUTURE EMBEDDING IN A 35-YEAR-OLD FEMALE PATIENT. ALL SUTURES WERE REMOVED THROUGH A SMALL INCISION. IN CONCLUSION, IT IS NECESSARY TO CHOOSE APPROPRIATE LAYER OF SKIN TO EMBED SUTURES ON THE BASIS OF FACIAL ANATOMY. GENTLY AND ACCURATE OPERATION IS IMPORTANT. THE COMBINATION OF THE ABOVE 2 POINTS IS THE KEY TO ACHIEVE GOOD POSTOPERATIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1627756 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention