BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 12625718 · Received October 13, 2021

    Report

    Report Number
    2210968-2021-09613
    Event Type
    Injury
    Date Received
    October 13, 2021
    Date of Event
    May 15, 2020
    Report Date
    October 13, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS, DEMOGRAPHICS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 1. DOES THE AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL SUTURE, SILK SUTURE AND NYLON SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OP COMPLICATIONS (POSTOPERATIVE HEMORRHAGE, WOUND DEHISCENCE, INFLAMMATORY REACTION TO SUTURES, INCISION SCAR AND VERMILION SHAPE, HYPERPLASIA SCAR AND LOCAL NUMBNESS) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. 2. DOES THE AUTHOR/SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE, SILK SUTURE AND NYLON SUTURE) USED IN THIS STUDY? 3. IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS (POSTOPERATIVE HEMORRHAGE, WOUND DEHISCENCE, INFLAMMATORY REACTION TO SUTURES, INCISION SCAR AND VERMILION SHAPE, HYPERPLASIA SCAR AND LOCAL NUMBNESS)? 4. WERE ALL THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION CITE: JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY (2020) 73, 2217¿2224 HTTPS://DOI.ORG/10.1016/J.BJPS.2020.05.077. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. EVENTS WERE SUBMITTED VIA 2210968-2021-09614 AND 2210968-2021-09615.

    Description of Event or Problem · 0

    TITLE: A COMBINED METHOD OF ORAL COMMISSURE LIFTING FOR PERIORAL REJUVENATION IN ASIANS THIS WAS A RETROSPECTIVE STUDY OF PATIENTS WHO UNDERWENT ORAL COMMISSURE LIFTING BETWEEN OCTOBER 2012 AND MARCH 2019 AT THE DEPARTMENT OF PLASTIC SURGERY, PEKING UNIVERSITY THIRD HOSPITAL. THIS STUDY WAS APPROVED BY THE MEDICAL SCIENCE RESEARCH ETHICS COMMITTEE OF PEKING UNIVERSITY THIRD HOSPITAL. 159 PATIENTS OF CONGENITAL ORAL COMMISSURE DROOPING UNDERWENT BILATERAL ORAL COMMISSURES LIFTING PROCEDURES. THEN SUBCUTANEOUS DISSECTION WAS PERFORMED UPWARD FROM THE INCISION TO THE IPSILATERAL NASAL ALAR WHERE THE LIGAMENT ATTACHED TO THE PYRIFORM APERTURE WAS REACHED, AND THE ORAL COMMISSURE TISSUE WAS SUSPENDED HERE WITH 4-0 SILK SUTURE (JOHNSON & JOHN- SON, USA). AFTER OBSERVATION OF THE INSTANT IMPROVEMENTS AND SYMMETRY OF ORAL COMMISSURES, HEMOSTASIS WAS APPLIED CAREFULLY AND THE WOUND WAS CLOSED WITH 5-0 VICRYL ABSORBABLE SUTURES (JOHNSON & JOHNSON, USA) USING THE BURIED SUBCUTANEOUS SUTURE TECHNIQUE. IN THE END, SKIN WAS CLOSED WITH 7-0 NYLON SUTURE (JOHNSON & JOHNSON, USA) WITHOUT DRESSING. REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE HEMORRHAG(N=2), WOUND DEHISCENCE (N=1), INFLAMMATORY REACTION TO SUTURES(N=25), EIGHT PATIENTS WERE UNSATISFIED DUE TO INCISION SCAR IN 4 PATIENTS, VERMILION SHAPE 4, FOR THE FOUR PATIENTS WITH INCREASED SECONDARY EXTROVERSION OF THE VERMILION OF THE UPPER LIP, TWO UNDERWENT SECONDARY SURGERY FOR LOCAL REDUCTION, AND THE EXTROVERSION WERE IMPROVED. LONG TERM COMPLICATION: NINE PATIENTS WITH OBVIOUS INCISIONAL SCARS, SEVEN CASES OF HYPERPLASIA SCAR RECEIVED INTRALESIONAL STEROIDS (COMPOUND BE- TAMETHASONE INJECTION, SCHERING-PLOUGH LABO N.V. BELGIUM) INJECTION, AND TWO CASES OF PITTING AND IRREGULARITY SCAR RE- CEIVED CO 2 MATRIX LASER TREATMENT. SIX OUT OF THE NINE PA- TIENTS WERE IMPROVED AND THE SCARS BECAME INVISIBLE OVER A DISTANCE OF 0.5 M AFTER A COURSE OF TREATMENT, AND THE REMAINING THREE POOR-RESULT CASES WITH A HYPERPLASIA SCAR AT THE LINE D INCISION UNDERWENT SCAR RESECTION BY EXTEND- ING THE INCISION ALONG THE LOWER LIP, WHICH WAS FINALLY HID- DEN IN THE VERMILION BORDER, AND NO HYPERPLASIA SCAR WAS FOUND AFTER RECOVERY. LOCAL NUMBNESS(N=2) IN CONCLUSION THE COMBINED TECHNIQUE FOR THE ORAL COMMISSURE LIFTING DISPLAYED A SIGNIFICANT EFFECT WITH LITTLE COMPLICATION IN ASIAN PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520551 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention