BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 16094785 · Received January 4, 2023

    Report

    Report Number
    2210968-2023-00045
    Event Type
    Injury
    Date Received
    January 4, 2023
    Date of Event
    September 1, 2022
    Report Date
    January 4, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? 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? 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. RELATED EVENTS CAPTURED VIA 2210968-2023-00044 AND 2210968-2023-00045. CITATION: J CRANIOFAC SURG (SEPTEMBER 2022); 33(6):1813¿1815. HTTPS://DOI.ORG/10.1097/SCS.0000000000008455.

    Description of Event or Problem · 0

    TITLE: COMPLICATION RATES FROM OTOPLASTY AT A TERTIARY FACIAL PLASTIC SURGERY CENTER: A RETROSPECTIVE ANALYSIS. THE AIM OF THIS RETROSPECTIVE CROSS-SECTIONAL STUDY WAS TO DETERMINE THE SURGICAL OUTCOMES AND COMPLICATIONS OF OTOPLASTY AMONG PATIENTS WHO UNDERWENT THIS PROCEDURE AT A TERTIARY FACIAL PLASTIC SURGERY CENTER AT KING ABDULAZIZ UNIVERSITY HOSPITAL IN RIYADH, SAUDI ARABIA. A TOTAL OF 44 PATIENTS (25 MALE AND 19 FEMALE; MEAN AGE OF 21.04 YEARS) WITH 85 PROMINENT EARS (PE) DEFORMITIES UNDERWENT OTOPLASTY BETWEEN JANUARY 2019 AND JUNE 2021. OF THESE, 17 WERE PEDIATRIC PATIENTS AND 27 WERE ADULTS. 41 PATIENTS UNDERWENT BILATERAL OTOPLASTY AND 3 UNDERWENT UNILATERAL OTOPLASTY. MUSTARDE SUTURE WERE PLACED USING 4-0 MERSILENE (ETHICON US, LLC, NEENAH, WI) WITH A NEEDLE LENGTH OF 19 MM, AND FURNASE SUTURE WAS PLACED USING 3-0 MERSILENE (ETHICON US, LLC) WITH A NEEDLE LENGTH OF 24 MM. THE SKIN WAS CLOSED USING A 5-0 VICRYL RAPIED (ETHICON US, LLC), AFTER WHICH GELONET DRESSING AND PRESSURE DRESSING WERE APPLIED. REPORTED COMPLICATIONS INCLUDE RECURRENCE (N=4), HYPERTROPHIC SCAR (N=3), KELOID (N=2), GRANULOMA (N=2), INFECTION (N=2)WITH (N=1) ASSOCIATED WITH DISCOMFORT, WOUND DEHISCENCE (N=1), HEMATOMA (N=1), AND RETRACTED EAR (N=1). IN CONCLUSION, AMONG OTOPLASTY PATIENTS TREATED USING THE MUSTARDE AND FURNASE TECHNIQUE, POSTOPERATIVE COMPLICATIONS VARIED FROM MILD TO SEVERE, BUT THAT ALL COMPLICATIONS WERE MANAGEABLE, AND THE INCIDENCE RATES WERE CLOSE TO THOSE PREVIOUSLY REPORTED IN THE LITERATURE. OUR STUDY HIGHLIGHTED KELOID COMPLICATIONS AS THE MOST DIFFICULT COMPLICATION, AND FOUND ACCEPTABLE OVERALL SATISFACTORY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199430 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention