BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9959055 · Received April 14, 2020

    Report

    Report Number
    2210968-2020-03032
    Event Type
    Injury
    Date Received
    April 14, 2020
    Report Date
    March 18, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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. 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 ETHICON PRODUCTS (VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE) USED IN THIS PROCEDURE? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS. CITATION: BIOMEDICAL RESEARCH 2018; 29 (11): 2342-2346. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: ROLE OF QUILTING TECHNIQUE OF MASTECTOMY FLAP IN PREVENTION AND REDUCTION OF SEROMA COMPLICATION IN BREAST CANCER PATIENTS." AUTHORS: MOHEND A. N. AL-SHALAH. CITATION: BIOMEDICAL RESEARCH 2018; 29 (11): 2342-2346. THE AIM OF THIS STUDY IS TO EVALUATE EFFECTIVENESS OF QUILTING OR TACKING MASTECTOMY FLAP TO THE UNDERLYING MUSCLES AND FASCIA TO OBLITERATE THE SURGICAL DEAD SPACE BY INTERRUPTED ABSORBABLE SUTURING IN PREVENTING OR REDUCING SEROMA FORMATION. THIS PROSPECTIVE COHORT STUDY INVOLVES 82 PATIENTS (MEAN AGE: 47.01± 10.17 YEARS) WITH DIAGNOSED BREAST CANCER AND AGREED TO DO MASTECTOMY WITH AXILLARY CLEARANCE SURGERY BETWEEN DECEMBER 2010 AND DECEMBER 2016 . PATIENTS WERE DIVIDED IN TWO GROUPS ACCORDING TO THE TECHNIQUE OF CLOSURE OF MASTECTOMY FLAP. NON-QUILTING TECHNIQUE WAS DONE TO THE FIRST GROUP OF PATIENTS (N-47; NON QUILTING TECHNIQUE GROUP) BETWEEN DECEMBER 2010 TILL JANUARY 2014 AND THE QUILTING TECHNIQUE WAS DONE FOR SECOND GROUP OF PATIENTS (N-35; QUILTING TECHNIQUE GROUP) IN-BETWEEN FEBRUARY 2014 TILL DECEMBER 2016. IN THE NON-QUILTING TECHNIQUE, THE SKIN EDGE AFTER MASTECTOMY WAS APPROXIMATED WITH 2/0 VICRYL SUTURE (ETHICON) AND CLOSED SUBCUTICALLY USING 0 NYLON SUTURE. IN THE QUILTING TECHNIQUE, AFTER MASTECTOMY AND AXILLARY CLEARANCE COMPLETION, MULTIPLE INTERRUPTED SUTURES WERE TAKEN STARTING IN THE LOWER FLAP FROM MEDIAL TO LATERAL BETWEEN THE MASTECTOMY FLAP AND UNDERLYING PECTORALIS MUSCLE AND FASCIA TACKING BETWEEN THEM USING 2/0 VICRYL SUTURE (ETHICON) TO OBLITERATE THE DEAD SPACE UNDERNEATH THE MASTECTOMY FLAP WITH CARE TO AVOID DIMPLING OF THE DERMIS. THE SECOND ROW WAS DONE BY THE SAME INTERRUPTED SUTURE FROM LATERAL TO MEDIAL TILL THE MEDIAL ANGLE. THE SAME WAS DONE FOR THE UPPER FLAP. THE SKIN EDGE AFTER MASTECTOMY WERE APPROXIMATED WITH 2/0 VICRYL SUTURE (ETHICON) AND CLOSED SUBCUTICALLY USING 0 NYLON SUTURE. REPORTED COMPLICATION IN THE NON QUILTING GROUP INCLUDED SEROMA (N-22) IN WHICH A TWO REDIVAC DRAIN WERE LEFT, ONE IN THE AXILLA AND THE OTHER UNDERNEATH MASTECTOMY FLAP AND WHICH REQUIRED ASPIRATION. REPORTED COMPLICATION IN THE QUILTING GROUP INCLUDED SEROMA (N-7) IN WHICH A REDIVAC DRAIN WAS LEFT ONLY IN THE AXILLA AND WHICH REQUIRED ASPIRATION. QUILTING OR TACKING MASTECTOMY FLAP TO THE UNDERLYING MUSCLES AND FASCIA TO OBLITERATE THE SURGICAL DEAD SPACE IS EFFECTIVENESS IN PREVENTION AND REDUCTION OF SEROMA FORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421311 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention