BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VICRYL RAPIDE SUTURE

    MDR report key: 20833676 · Received December 3, 2024

    Report

    Report Number
    2210968-2024-12759
    Event Type
    Injury
    Date Received
    December 3, 2024
    Date of Event
    January 1, 2024
    Report Date
    December 3, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    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. AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATIONS: DERMATOL SURG.2013;39:734¿8.PAGES :1-3.

    Description of Event or Problem · 0

    TITLE : IMMEDIATE CRYOTHERAPY AFTER CORE EXCISION: A PROMISING APPROACH TO REDUCE MECHANICAL TENSION IN RECALCITRANT KELOIDS. THE AIM OF THIS STUDY WAS TO INTRODUCES A NEW APPROACH INVOLVING CORE EXCISION WITH SIMULTANEOUS CRYOTHERAPY FOR TREATING RECALCITRANT KELOIDS IN DIFFERENT LOCATIONS. A RETROSPECTIVE ANALYSIS WAS CONDUCTED ON 10 PATIENTS (5 MEN AND 5 WOMEN), ENCOMPASSING 15 KELOID SCARS, WHO UNDERWENT CORE EXCISION AND SIMULTANEOUS CRYOSURGERY AT THE DEPARTMENT OF DERMATOLOGY, SEVERANCE HOSPITAL,BETWEEN MAY 2019 AND AUGUST 2022. THE MEDIAN AGE OF THE 10 PATIENTS WAS 31 YEARS (RANGE, 22;51YEARS). AFTER TRIMMING THE REDUNDANT FLAP, THE WOUND WAS CLOSED WITHOUT TENSION USING A 5-0 VICRYL RAPID THREAD. THE REPORTED COMPLICATIONS INCLUDED BACTERIAL INFECTIONS (N=1) AND RECURRENCE (N=2). IN CONCLUSION, THE COMBINATION OF CORE EXCISION AND SIMULTANEOUS CRYOTHERAPY IS A SAFE AND EFFECTIVE TREATMENT OPTION FOR RECALCITRANT KELOIDS IN VARIOUS LOCATIONS. THIS PROCEDURE RESULTED IN SIGNIFICANT IMPROVEMENTS IN THE VANCOUVER SCAR SCALE SCORE, PARTICULARLY IN THE HEIGHT AND PLIABILITY SUBCATEGORIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2202124 UNKNOWN VICRYL RAPIDE SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention